Total 48 Manager Management job vacancies in Quality Assurance / Control category in Malaysia

Job Description:

-Provide oversight on all compliance and risk management matters across business operations with relevant l-legislation/ regulations/ rules/ internal policies
-Monitor and assess regulatory updates, and provide advisory on compliance and risk implications of business decisions, both for on-going issues and in project decisions
-Provide advice and conduct training on regulatory and risk matters internally
-Liaise and coordinate with MAS and SGX on all reporting and submission requirements as well as addressing any queries
-Provide advice to CEO and management team on new products and initiatives including all regulatory and risk requirements. Support management through the provisions and implementation of new policies
-Build and maintain strong framework of compliance and risk management policies, procedures and programs, including but not limited to enterprise-wide risk assessment and annual compliance monitoring review program
-Work closely with internal stakeholders to deliver compliance and risk programs in Singapore office
-Establish and maintain effective relationship with MAS, SGX and other relevant authorities
-Provide assistance in legal matters and liaise with external legal counsel
-Undertake additional functions and duties when required

Requirements:

-Graduate with a Degree in Finance/ Accountancy/ Law
-At least 5 - 10 years of experience within Compliance and/ or Risk Management function in banks/ brokerage firms and experience in various businesses (e.g. corporate finance, global markets, asset management, private wealth management, institution equity) will be an added advantage
-Strong knowledge of SFA & FAA (including its subsidiary legislations and related regulatory instruments issued by MAS) as well as SGX rules requirements
-Oversight experience in compliance/ risk management monitoring programs/ models, or policy drafting experience
-Self-motivated individual who can accomplish tasks independently to meet compliance objectives and with excellent communication and stakeholder management skills

Interested applicants, please send your resume to sg.hr@htisec.com

Our client is an asset management firm that invests in multi-asset classes such as private equity funds, credit funds etc. As the business continues to grow, they are looking for a Compliance Manager and the role is based in Singapore.

Responsibilities:

• Liaise with regulators on regulatory license requirements and compliance filing
• Manage and update the firm’s compliance policies and framework
• Keep track of new regulatory development and provide updates to the firm
• Update and advise the management on compliance issue and ensure the firm is in line with the regulatory standard and requirements
• Assist in KYC/AML review on investors, CRS/FATCA filing
• Identify any potential compliance issues and provide solutions to the business
• Provide compliance training and updates to the firm’s employees
• Participate in compliance projects when necessary

Skills / experience requirements

• At least four years of Compliance experience in the Asset Management / Fund Management experience
• Bachelor’s degree or other tertiary qualification
• Good understanding on regulatory compliance
• Good communication and analytic skills
• Hands-on and adaptable to work in a small office environment
• Meticulous, diligent, motivated

Interested parties please send your resume to Loretta Chan at loretta@amethystasiapartners.com

Regrettably only shortlisted candidates will be contacted

EA License Number: 20C0180| Registration no: R1876188 |

• Take the lead in driving IT service maturity and information security risk management with your strong stakeholder management skills
• Flat structure with flexibility and autonomy
• Fast paced environment – established Maritime MNC

Key Responsibilities:

• Govern cyber information risk management and compliance, including risk documentation and remediation.
• Ensure alignment with industry frameworks and regulations such as NIST, CIS Controls, and BIMCO.
• Manage audits and maintain compliance with regulations, overseeing access rights.
• Lead IT service, application, and vendor management, coordinating with business partners to drive enhancements.
• Oversee IT problem management and establish SOPs for improved ecosystem management.
• Collaborate with stakeholders to consolidate vendors and enhance procurement processes.
• Support project handover and change advisory board discussions.

Qualifications & Experience:

• Minimum qualification in Information Systems or Computer Science.
• Minimum 7 years of experience in IT Service Management, Risk Management, and Governance.
• Proficiency in managing IT risk registers, problem management, and vendor relationships.
• Solid understanding of technical IT aspects including cyber, cloud computing, and infrastructure.
• ITIL Foundation Certified and experienced in building capabilities within smaller teams.

If you are interested in the above position or other cyber security or IT compliance positions, please kindly send your updated CV to Shannagh.Wu@ethosbc.com.
*Due to high volume of applications, only shortlisted applicants will be contacted.*

Reg No.R23112660
BeathChapman Pte Ltd
Licence no. 16S8112

• Well Established Company
• Basic $6800 - $8000 + AWS + Variable Bonus
• Excellent Welfare and Benefits + Career progression
• Working location: Boon Lay
• Working day: Monday to Friday
• Working hours: 8.30am to 5.30pm

Job Responsibilities:

• Maintain the Quality Management System to ensure compliance with ISO 13485:2016 requirements, applicable international standard/regulation requirements, and customer requirements
• Identify the gap in the QMS and make continuous improvements to ensure the effectiveness of QMS implementation and consistency with product and process requirements. Lead the training on procedures and practices to QMS requirements
• Lead the internal audit and customer audit, follow-up on audit non-conformance activities till closure
• Responsible for major customer projects and quality deliveries, handling product quality issues, and responding to major customer complaints and quality improvement
• Authorize the release of major customer products
• Manage and verify CAPA, NCR, SCAR handling, root cause analysis, and action taken
• Risk management, validation and verification activities
• Provide the necessary training, such as QMS, supplier management, design control, MSA, G R&G, 8D etc.
• Support on monthly quality objective and KPI review
• Support on Quality Management Review
• Any other duties as assigned from time to time

Job Requirements:

• Bachelor’s Degree with minimum 5 years of experience in quality management/ assurance and/or risk assessment in medical device industry
• Qualified lead auditor or ISO 13485:2016 internal auditor, be familiar with ISO 14971:2019, Cleanroom, and applicable regulatory and standards

Candidates are encouraged to apply this position via Apply Now button with the following information in the resume

• Work experiences and job responsibilities
• Current and Expected salary
• Reason for leaving
• Date of availability
• Education background

We regret that only shortlisted candidates will be contacted.

LIONG ZHAO GUAN (R22107632)

EA Recruitment Pte Ltd

EA License No: 21C0492

• Well Established Company
• Basic $6500 - $8000 + AWS + Variable Bonus
• Excellent Welfare and Benefits + Career progression
• Working location: Boon Lay
• Working day: Monday to Friday
• Working hours: 8.30am to 5.30pm

Job Responsibilities:

• Maintain the Quality Management System to ensure compliance with ISO 13485:2016 requirements, applicable international standard/regulation requirements, and customer requirements
• Identify the gap in the QMS and make continuous improvements to ensure the effectiveness of QMS implementation and consistency with product and process requirements. Lead the training on procedures and practices to QMS requirements
• Lead the internal audit and customer audit, follow-up on audit non-conformance activities till closure
• Responsible for major customer projects and quality deliveries, handling product quality issues, and responding to major customer complaints and quality improvement
• Authorize the release of major customer products
• Manage and verify CAPA, NCR, SCAR handling, root cause analysis, and action taken
• Risk management, validation and verification activities
• Provide the necessary training, such as QMS, supplier management, design control, MSA, G R&G, 8D etc.
• Support on monthly quality objective and KPI review
• Support on Quality Management Review
• Any other duties as assigned from time to time

Job Requirements:

• Bachelor’s Degree with minimum 5 years of experience in quality management/ assurance and/or risk assessment in medical device industry
• Qualified lead auditor or ISO 13485:2016 internal auditor, be familiar with ISO 14971:2019, Cleanroom, and applicable regulatory and standards

Candidates are encouraged to apply this position via Apply Now button with the following information in the resume

• Work experiences and job responsibilities
• Current and Expected salary
• Reason for leaving
• Date of availability
• Education background

We regret that only shortlisted candidates will be contacted.

LIONG ZHAO GUAN (R22107632)

EA Recruitment Pte Ltd

EA License No: 21C0492

Our client focuses on real estate investment, real estate development, and hospitality as its areas of interest in the key cities across Asia Pacific regions.

Responsibilities:

• Follow-up with process owners to ensure recommendations put forth by Internal Auditors are duly implemented.
• Perform internal control reviews on ad-hoc projects assigned.
• Ensure Group policies and procedure manuals are updated before dissemination to staff.
• Ensure compliance with local rules and regulations (e.g. set by URA, SGX, etc.)
• In-charge of business continuity management (BCM) project.
• Manage/ review risk framework, maintain risk register, prepare annual risk report and write-up on risk management section of the Sustainability Report.
• Ensure Internal Control Self-Assessment Checklist is completed by the various Business Units on an annual basis.

Requirements:

• A degree in Accountancy/ACCA with professional CA qualification or CIA certification would be an advantage.
• Relevant 8 years’ experience in internal control, risk management, internal audit and compliance, preferably in the Real Estate or Hospitality industry. Prior Big 4, and commercial ERM / Internal Audit / Internal Control experience will be a plus.

All applications will be treated in the strictest confidence. Personal data provided will be used for recruitment purposes only.

Please apply with your CV in word document format. We regret to inform that only shortlisted candidates will be notified. For other positions related to real estate, please go to https://careers.tri-cap.com.sg/.

EA Licence: 17C8777

​EA Personnel: R21102223

Job Objectives

The candidate will work closely with the respective stakeholders across the organisation to drive testing transformation which is aligned to the organisation’s transformation strategy.

Reporting to Test Lead, the candidate will ensure the overall successful delivery of all testing services provided by the organisation for any projects, change requests and production fixes for Customer Management & Credit Origination suite of applications.

The candidate is also expected to manage and ensure the successful the delivery of testing services provided by the organisation’s appointed test service providers, and in accordance to the organization’s standards and processes.

Key Responsibilities

· Overall accountable and responsible for delivery of testing services across the Customer Management & Credit Origination Domain.

· Manage and oversee the day-to-day delivery of test services by Bank appointed vendors in the conduct of testing

· Works with the testing service providers and other Bank’s stakeholders to review, provide feedback and sign off on the test strategy, test plans and other test service providers’ artefacts for the testing service delivery.

· Coordinates with the Test Governance team to ensure adoption of testing methods, standards and tools, and to coordinate any health checks or audits.

· Ensures that any changes to the scope of services are communicated to the respective test service providers and the impact is factored into the plan.

· Engages with various Bank’s stakeholders (including but not limited to, application, security, infrastructure, business), testing service providers to ensure testing services meet the banks’ objectives and demand.

· Act as the first point of escalation for any issues raised by the Bank’s stakeholders, testing service providers.

· Quantify, manage, track and report test related statuses, SLA and KPIs, and ensure that defined testing transformation SLA and KPI targets are met for the portfolio accountable.

· Drive and collaborate with all Bank’s stakeholders and test service providers to plan all testing related deliveries for the portfolio accountable.

· Participate and contribute in forums, as required, to drive testing transformation and innovation.

· Works closely with the Test Engineering Lead to provide inputs around domain specific test engineering requirements and ensure that they are met.

· Establishes and maintains effective working relationships with the Vendor Test Managers/Test Leads for the respective domains.

· Engages stakeholder communities to get their feedback on testing service delivery and identify improvement opportunities to be fed back to the Test team.

Qualifications and Skills Required

· Bachelor’s Degree or Master’s degree in computer engineering or related field.

· Proven working experience in test delivery or equivalent role with at least 12 to 15 years relevant experience in large and complex organisations preferably in the area of Banking and Finance and at least 5 years’ senior manager experience in testing.

· Extensive experience in managing end to end delivery of testing services from multiple vendor test service providers.

· Strong domain knowledge on Customer Management and Credit Origination. Experience in managing testing one or more areas of these domains will be an advantage.

· Proven experience in testing standards, tools, processes & methodologies, frameworks, and various delivery methodologies e.g. Agile, Hybrid Agile and Waterfall, DevOps.

· A proven, successful track record of managing shared IT service development and/ or IT Testing Services.

· Demonstrated success in developing highly effective working relationships with internal and external stakeholders to deliver collaboration, partnerships and services.

· Strong attention to details, excellent analytical and problem solving skills.

· Experience in managing multiple external testing service providers.

· Experience in managing multi-cultural, diverse, direct and virtual teams.

· Experience in various testing tool suites like HP UFT/QTP, Loadrunner/Performance Center/Sitescope, HP ALM / Quality Center, Tosca, Selenium, JIRA etc.

· Must display a high level of professional judgment, commitment, integrity, and teamwork.

· Excellent client facing, internal communications, written and verbal communication skills.

· Testing or quality certifications, PMP certifications, and Test Maturity Model integration (TMMi) Framework awareness will be preferred.

about the company

Our client is a leading materials testing laboratories and solutions provider for a wide range of fields including construction, life sciences, environmental, energy, transportation etc. They’re now on a look out for a Quality Engineer/Manager to join their dynamic team.

about the job

• Implement, maintain and improve the quality management system (QMS)
• Drive quality improvements and proactive participation in continuous improvement and process improvement projects
• Represent our Singapore and Malaysia business units during assessments by accreditation bodies and audits by clients and controlled document holding
• Interact with clients & Accreditation Bodies and be responsible for advising operational colleagues of the importance of quality, accuracy and integrity in the provision of the testing, calibration inspection and certification services we provide.
• Ensure buy-in to the effective implementation of our quality policies and procedure
• Manage scheduled internal audits across management system and technical disciplines
• Monitor laboratory test equipment for calibration currency and advise management of upcoming schedules,ensuring corrective and preventive actions identified within specific laboratories are implemented and verified in a timely manner.
• Manage external and internal proficiency testing programs and prepare compliance and improvement metrics as required.
• Write and review quality documentation and effective and efficient management of personal work schedules and timely generation of quality reports.

job requirement

• Diploma/Degree of Science or Engineering qualification.
• Minimum 2 years of managing quality management systems within a multi-discipline testing, inspection and certification environment
• Candidates with more experience (min 4 years) can be considered for the Quality Manager position.
• Demonstrable experience auditing against ISO/IEC 17025, ISO/IEC 17020 and ISO/IEC 17065.
• Sound knowledge of equipment calibration and analyzing proficiency test data.

If you are interested in the position, kindly apply directly or send your CVs to yiling.tan@randstad.com.sg.

We regret that only shortlisted candidates will be contacted

EA: 94C3609 / Reg: R21103172

Royal Brisbane Institute of Technology /Royal Brisbane International College Quality Assurance and Compliance Manager Needed

We, at Royal Brisbane Institute of Technology / Royal Brisbane International College are in Westbrook, Queensland.

We are introducing new courses and our mission is to deliver quality courses and teaching based on morals and values. Our college is closely affiliated to Pure Land Learning College Association Inc, Buddhist centre which follows the teachings of Venerable Master Chin Kung.

To achieve this vision, we seek a Full-time Quality Assurance & Compliance Manager

About the role

As Quality Assurance & Compliance Manager, you will be responsible for ensuring the training and assessment systems meet all requirements of the rules of evidence and principles of assessment so students can be assessed and issued with qualifications.

You will be in charge of establishing ties and partnership with other high-quality education providers within the VET and Higher Education Sectors and with Education Agencies. Your primary role will be to ensure consistent high quality of policies and procedures, partnership management, software and learning systems, validation and documentation.

Responsibilities


Design & maintain quality assurance, tools and processes for education systems



Ensuring policies and procedures are in accordance with the VET Quality Framework, government contracts and organisational needs.



Prepare reports, correspondence and present on quality assurance data and compliance activities to a range of internal and external stakeholders including the Board, Management, CEO and government bodies.



Ensure resources meet all the necessary standards/regulatory requirements



Consult with key product specialists to seek final quality assurance approval of materials



Work closely with the product development team and provide advice to mitigate any issues to satisfy quality and compliance standards



Maintaining systems objectives (PRISMS, JobReady, ASQA Net, etc as necessary



Ensure stakeholders engagement to main workflow and quality outputs


Qualification / Experience


Relevant Bachelor’s degree



At least 3 years’ experience in Quality Assurance and Compliance


Skills preferred:


Experience in compliance with the records, information and knowledge management requirements



Monitoring and adaptation of policies and procedures



Knowledge of ASQA standards and audits



Experience in managing compliance reporting systems



Practising Buddhist



Must be able to read, write and converse in Mandarin.



Able to speak some Chinese Dialects, i.e. Hokkien, Teochew, and Cantonese


Salary: $60,001 - $80,000

Application Deadline: 19/04/2024

Job Types: Full-time, Permanent

Salary: $60,001.00 – $80,000.00 per year

• Follow-up with process owners to ensure recommendation put forth by Internal Auditors are duly implemented.

• Perform internal control reviews on ad-hoc projects assigned.

• Ensure Group policies and procedure manuals are updated before dissemination to staff. • Ensure compliance with local rules and regulations (e.g. set by URA, SGX, etc.)

• In-charge of business continuity management (BCM) project.

• Manage/ review risk framework, maintain risk register, prepare annual risk report and writeup on risk management sec on of the Sustainability Report.

• Ensure Internal Control Self-Assessment Checklist is completed by the various Business Units on an annual basis.

Royal Brisbane Institute of Technology /Royal Brisbane International College Quality Assurance and Compliance Manager Needed

We, at Royal Brisbane Institute of Technology / Royal Brisbane International College are in Westbrook, Queensland.

We are introducing new courses and our mission is to deliver quality courses and teaching based on morals and values. Our college is closely affiliated to Pure Land Learning College Association Inc, Buddhist centre which follows the teachings of Venerable Master Chin Kung.

To achieve this vision, we seek a Full-time Quality Assurance & Compliance Manager

About the role

As Quality Assurance & Compliance Manager, you will be responsible for ensuring the training and assessment systems meet all requirements of the rules of evidence and principles of assessment so students can be assessed and issued with qualifications.

You will be in charge of establishing ties and partnership with other high-quality education providers within the VET and Higher Education Sectors and with Education Agencies. Your primary role will be to ensure consistent high quality of policies and procedures, partnership management, software and learning systems, validation and documentation.

Responsibilities


Design & maintain quality assurance, tools and processes for education systems



Ensuring policies and procedures are in accordance with the VET Quality Framework, government contracts and organisational needs.



Prepare reports, correspondence and present on quality assurance data and compliance activities to a range of internal and external stakeholders including the Board, Management, CEO and government bodies.



Ensure resources meet all the necessary standards/regulatory requirements



Consult with key product specialists to seek final quality assurance approval of materials



Work closely with the product development team and provide advice to mitigate any issues to satisfy quality and compliance standards



Maintaining systems objectives (PRISMS, JobReady, ASQA Net, etc as necessary



Ensure stakeholders engagement to main workflow and quality outputs


Qualification / Experience


Relevant Bachelor’s degree



At least 3 years’ experience in Quality Assurance and Compliance


Skills preferred:


Experience in compliance with the records, information and knowledge management requirements



Monitoring and adaptation of policies and procedures



Knowledge of ASQA standards and audits



Experience in managing compliance reporting systems



Practising Buddhist



Must be able to read, write and converse in Mandarin



Able to speak some Chinese Dialects, i.e. Hokkien, Teochew, and Cantonese


Salary: $60,001 - $80,000

Application Deadline: 18/04/2024

Job Types: Full-time, Permanent

Salary: $60,001.00 – $80,000.00 per year

Ebang International Holdings Inc., a NASDAQ-listed company. Over the years, we have established strong footprint and are known for our professionalism, secure, convenient and stable financial services platform in the digital assets world. Growing strong, we have obtained digital currency trading licenses and financial service licenses in regions such as Australia etc.

Join us in impacting a blueprint in the fintech world! We have subsidiaries/branches/offices in Singapore, Hong Kong, Australia and New York. Take your chance and join us!

The ideal candidate will help to ensure that all corporate processes and procedures comply with the law. Ensure that company operations comply with internal standards for all entities.

Compliance Manager/Senior Manager

Responsibilities

• Establish the Compliance function and put in place a compliance framework to ensure compliance with the local regulations (e.g. PSA and PDPA) and the Company’s policies
• Oversee the Compliance function and ensure that the operations and conduct of IR SG are compliant with regulatory and licensing requirements, e.g. Payment Services Act in Singapore.
• Develop manuals, compliance policies and procedures
• Key liaison officer to work with Monetary Authority of Singapore (MAS) and other regulatory bodies, and maintain best practices, policies, and procedures for all compliance obligations
• Provide compliance advice or trainings to the various business units
• Evaluate regularly internal controls and compliance programs through transaction analysis, compliance reviews/ compliance framework and training sessions
• Provide information and updates to Senior Management and the Board, and apprise them on money laundering, terrorist financing and PDPA identified risks and related action plans
• Actively monitor regulatory notices and developments in Singapore and other international jurisdictions that might impact the operations of IR SG.
• Not limited to management and implementation of appropriate AML/CFT policy and procedures in line with the risk management framework and regulatory requirements and maintaining an internal reporting process for handling Suspicious Activity Reports
• Any ad-hoc duties assigned globally by management

Requirements

• Degree and above qualification are highly preferred
• Minimum 8 years of experience working in a Compliance function in a regulated financial services institution/ Payments firm would be an advantage.
• Expertise in financial services regulation in Asia Pacific, specifically the Payment Services Act in Singapore.
• Good to have global compliance experience
• knowledge of derivatives products, platforms and regulations (preferred).
• Proven experience with dealing with regulatory authorities, with experience directly engaging with MAS highly regarded.
• Skilled at identifying any gaps in process and compliance frameworks and implement tailored solutions.
• Leadership and key stakeholder engagement skills and experience required.
• Excellent verbal and written communication, presentation, and leadership skills.
• Demonstrates high levels of intelligence, a positive attitude, and patience.
• Logical and analytical in approach with a problem-solving attitude.
• Resilient in withstanding pressure and delivering efficiently.
• The candidate must be proactive, independent, adaptable, with effective communication and interpersonal skills.
• You are not restricted to what has been assigned only but always looking to add value for process improvement and standardization.
• Ability to work well under pressure with a high level of motivation and tenacity.
• Ability to cope with the fluid nature of the role.
• Proactive in seeking guidance and willing to contribute wherever and whenever asked.
• Proficient in Chinese and English is highly preferred due to business nature in managing external and internal parties.
• Must have: Payment Services Act (PSA), Compliance Formulation and PDPA experience

Am Standort in Büchen suchen wir zum nächstmöglichen Zeitpunkt eine/n Quality Manager für Claim Management (w/m/d) zur Verstärkung unseres Teams.

Responsibilities / Tasks

• Abwicklung von internen und externen Kundenreklamationen

• Durchführung von Fehler- und Ursachenanalysen

• Koordination aller beteiligten Abteilungen im Rahmen von Reklamationsbearbeitungen

• Kommunikation der „Lessons Learned“ an die Stakeholder

• Einleiten von Maßnahmen zur Fehlervermeidung und Qualitätssicherung

• Erstellung von Untersuchungsberichten, 8D-Reports und Fehlerauswertungen

Your Profile / Qualifications

• Sie haben ein abgeschlossenes Bachelor Studium oder sind Techniker/in den Fachrichtungen: Maschinenbau, Elektrotechnik oder Mechatronik

• Idealerweise verfügen Sie über Erfahrungen im Umgang mit Prozesskomponenten in hygienischen Anwendungen

• Sie überzeugen durch eine systematische wie pragmatische Vorgehensweise, Organisationsgeschick und Umsetzungsstärke

• Sie arbeiten selbstständig, gern mit Kunden und in einem internationalen Team

• Sie bringen gute Kenntnisse in MS Office und SAP mit

• Sie kommunizieren sicher in Deutsch und Englisch

Wir bieten:

• Flexible Arbeitszeiten

• Mobiles Arbeiten möglich

• Strukturierte Einarbeitung

• Familiäres Arbeitsumfeld

• Gute Anbindung an öffentliche Verkehsmittel

• JobRad

• 30 Tage Urlaub

• Kantine am Standort

• Kostenfrei Parkplätze

Did we spark your interest?
Then please click apply above to access our guided application process.

Quality Assurance Manager (m/w/d) Change/CAPA Management & Product Quality Review 

an unserem Standort in Freiburg, zunächst befristet für 2 Jahre

Das erwartet Sie:

• Mitarbeit in den Qualitätssystemen Change Management, CAPA Management und Product Quality Review (PQR)
• Sicherstellung der Compliance mit gesetzlichen und Konzern-Anforderungen
• Genehmigung von Change Control Protokollen, Berichten und Maßnahmen sowie Koordination und Überwachung der fristgerechten Umsetzung dieser
• Planung, Erstellung und Nachverfolgung des zeitgerechten Abschlusses von Product Quality Reviews inklusive zugehöriger Maßnahmen
• Systemverantwortliche(r) entsprechender Datenbank-Module, Schulung und Unterstützung der Fachbereiche
• Kontinuierliche Systempflege und Verbesserung
• Festlegung, Monitoring und Auswertung von Kennzahlen
• Erstellen und Schulen zugehöriger SOPs
• Präsentation der Qualitätssysteme bei Audits
• Vertretung / Mitarbeit bei anderen Qualitätssystemen

Das bringen Sie mit:

• Approbation als Apotheker (m/w/d) oder ein abgeschlossenes naturwissenschaftliches Studium
• Mehrjährige Berufserfahrung im Bereich pharmazeutische Produktion, Qualitätskontrolle oder Qualitätsmanagement, adäquate Fort‐ und Weiterbildung
• Erfahrung und Spezialwissen im Bereich Change/CAPA Management oder Product Quality Review wünschenswert
• Kenntnisse des aktuellen regulatorischen und arzneimittelrechtlichen Umfeldes (D, EU, USA, JP)
• Ein ausgeprägtes Qualitäts- und GMP-Bewusstsein
• Die Fähigkeit, Strategien und Konzepte zu entwickeln und umzusetzen
• Sicheres Auftreten sowie ausgeprägte Kommunikationsfähigkeiten
• Sehr gute Kenntnisse der deutschen und englischen Sprache in Wort und Schrift
• Gute EDV‐Kenntnisse

  
 

Gemeinsam stehen wir für: 

Breakthroughs that change patients' lives – Um unseren Unternehmenszweck zu erfüllen, leitet eine wertorientierte Unternehmenskultur unser Handeln. Pfizers Werte sind: Courage, Excellence, Equity & Joy.

Courage: Eine mutige Art und Weise, wie wir unsere Ziele erreichen, ist unsere unternehmensweite Strategie der digitalen Transformation. Unsere flachen Hierarchien ermöglichen kurze Entscheidungswege.

Excellence: Wir fokussieren uns auf das, was wirklich wichtig ist, übernehmen Verantwortung, messen Fortschritte und arbeiten vertrauensvoll zusammen. Gemeinsam setzen wir auf eine agile Arbeitsweise, die unsere Mitarbeiter:innen dazu ermutigt, sowohl ihr Privat- und Arbeitsleben in Einklang zu bringen als auch die persönliche Weiterentwicklung voranzutreiben. 

Equity: Wir sind davon überzeugt, dass unterschiedliche Erfahrungen wertvoll sind, weshalb jede Meinung gehört und wertgeschätzt wird. Diese Erfahrungen und Meinungen bereichern das gesamte Unternehmen. So fördern wir ein vielfältiges und inklusives Arbeitsumfeld in dem sich Kolleg:innen in verschiedenen Diversity, Equity & Inclusion (DE&I) Arbeitsgruppen wie, u. a. Empowered Women, LGBT*IQ , DisAbility, X-Gen engagieren. 

Joy: Wenn wir unsere Arbeit als sinnstiftend erleben, erhalten wir auch viel zurück. Das erreichen wir, indem wir stolz auf den Beitrag sind, den wir leisten, uns gegenseitig wertschätzen und dies auch mit Freude und Anerkennung teilen. Unser BRAVO Award Programm gibt uns hier eine wertschätzende Möglichkeit dazu. Unsere Mitarbeiter:innen profitieren auch während der Arbeitszeit von einem umfangreichen Betrieblichen Gesundheitsmanagement "Pfizer in Balance".

Wir glauben an Partizipation und binden unsere Mitarbeiter:innen aktiv in unser gesellschaftliches Engagement ein. So schaffen wir ein gemeinsames Werteverständnis und ermöglichen jedem, diese im Arbeitsalltag einzubringen und weiterzutragen. Die Möglichkeit sich sozial zu engagieren, erhalten Sie bei uns u.a. während der Engagement Tage, durch Online Mentoring für Geflüchtete und vieles mehr.

Selbstverständlich sind für uns eine faire Vergütung nach dem Tarifvertrag IG BCE sowie eine ansprechende Altersvorsorge und viele weitere attraktive Benefits. 

Weiterführende Informationen erhalten Sie auf unserer Website unter: Arbeiten bei Pfizer Deutschland 

Bei weiteren Fragen stehe ich Ihnen sehr gerne zur Verfügung.
Luisa Strack I karriere@pfizer.com 

Quality Assurance and Control

Your role

• You will contribute and support maintenance and effectiveness of CZM’s Quality Management System in compliance with regulatory requirements, quality strategy and business needs

• Executing governance as well as taking on a moderating role about internal QMS requirements, the function drives best practice sharing across the organization and ensures best fit of the QMS for business

• You will take on a coordinating role for internal / external audits and inspections

• You will provide and manage tools to monitor QMS compliance, effectiveness and efficiency

• You will contribute to fulfilling general requirements for QMS in interaction with external stakeholders such as Authorities/Notified Bodies and distributing sites

• Moreover, you will lead or contribute to QMS projects for further standardization and continuous improvement, including steering of corrective and preventive actions

Your profile

• Master’s degree, preferably in scientific/technical studies or business administration or equivalent work experience in combination with another degree

• At least 5 years proven experience in Quality Management or Regulatory Affairs in the medical device industry

• Experience in project management or consultancy, taking leading role in standardization or business process excellence projects

• Strong knowledge of statutory and regulatory requirements that apply to medical device industry (e.g. ISO 13485, MDR)

• Methodological and task-specific qualifications (e.g. internal auditor)

• Knowledge on implementing management and internal control systems including their monitoring

• Conceptual strength, open "out-of-the-box" thinking and experience in the coordination of cross-disciplinary collaboration

• A working knowledge of collaborative tools (e.g. SharePoint, Teams, etc.)

• A passion for management systems, cross-department intercultural teamwork and the willingness to travel

• Strong communication, networking and analytical skills as well as the ability to handle conflicts

• A high level of commitment and outstanding initiative; objectivity in your work

• Very good written and spoken English

Your ZEISS Recruiting Team:

Marina Löw