Total 21 module manager job vacancies in Quality Assurance / Control category in Pasir Gudang, Johor

Job Responsibilities:

1. New product registration:

• Prepare and compile registration dossiers in accordance with relevant regulatory requirements including: 
  

  • Constructing/ editing letters of response/ justification/ declaration and clinical documentation for submission packages in accordance with guidelines checklists.

  • Compile/ review/check material for dossier prior to submission, incorporate feedback from relevant stakeholders.

  • Conduct checks on artworks to ensure in compliance with local regulation.

• Submit product registration applications to local health authorities  according to target submission timelines.
• Liase with and respond to additional requests or queries from health authorities and follow up (when necessary) until approval per target timelines.
• Liase with enternal and external stakeholders/ departments to build rapport and to achieve target outcomes.

2. Comply with regulatory requirements: to maintain validity of existing licenses/ certification/ authorization (e.g, product licenses, manufacturing licenses, establishment license, GDPMD licenses, import/ export license) through timely variations and/ or renewals to ensure supply continuity.

3. Keep abreast of regulatory updates from health authorities in the drugs, cosmetics, and medical device space.

• Assess regulatory updates on impact to business and communicate insights on approach to handle affairs.
• Propose solutions to arising issues.

4. Update and maintain database of regulatory and product registration information.

5. Good maintenance of final submitted documentation and local repository.

6. Ensure compliance with quality procedures stipulated for regulatory affairs, its administartive maintenance, and plan/ suggest improvements to operations.

7. Support any audits or inspections.

8. Guide/ oversee work performance and development of direct report.

9. Provide input for periodic operation metrics/ budget initiatives by managing  operating expenses within approved budget for the year.

10. Handle any other assingment as advised by supervisor.

Requirements: 

• Possess a Bachelor Science
• Work experience in regulatory affairs.
• Familiar with drugs/ cosmetics/ medical device regulatory landscape and GxP related matters.
• Proficiency in Microsoft Office Applications and relevant regulatory system software.
• Adopt good practices in documentation and communication.

Perks & Benefits

• Allowance ( mileage,transportation)
• Medical insurance

工作職責：

1、新產品註冊：

• 根據相關監管要求準備和編制註冊檔案，包括：
  

  • 根據指南清單建立/編輯提交包的回應/理由/聲明和臨床文件。

  • 在提交之前編譯/審查/檢查檔案資料，納入相關利害關係人的回饋。

  • 對藝術品進行檢查，以確保符合當地法規。

• 根據目標提交時間表向當地衛生部門提交產品註冊申請。
• 與衛生當局聯絡並回應其他請求或詢問，並跟進（必要時）直至按照目標時間表獲得批准。
• 與內部和外部利害關係人/部門聯絡，建立融洽關係並實現目標成果。

2. 遵守監管要求：透過及時變更和/或更新來維持現有許可證/認證/授權（例如產品許可證、製造許可證、企業許可證、GDPMD許可證、進出口許可證）的有效性，以確保供應連續性。

3. 隨時了解衛生當局在藥品、化妝品和醫療器材領域的最新監管動態。

• 評估監管更新對業務的影響，並就處理事務的方法傳達見解。
• 針對出現的問題提出解決方案。

4.更新和維護監管和產品註冊資訊資料庫。

5. 妥善維護最終提交的文件和本機儲存庫。

6. 確保遵守監管事務、行政維護規定的品質程序，並規劃/建議營運改善。

7. 支持任何審計或檢查。

8. 指導/監督工作績效和直接報告的發展。

9. 透過在年度核准的預算內管理營運費用，為定期營運指標/預算計畫提供輸入。

10. 處理主管建議的任何其他分配。

要求：

• 擁有科學學士學位
• 監管事務方面的工作經驗。
• 熟悉藥品/化妝品/醫療器材監管環境和 GxP 相關事宜。
• 熟練Microsoft Office應用程式和相關監管系統軟體。
• 在文件和溝通方面採用良好的做法。

津貼和福利

• 津貼（里程、交通）
• 醫療保險

The Quality Control manager is responsible for the maintenance and improvement of operational service quality. Reporting directly to Singapore DGM, you will work cross-functionally with our various Business Units (BUs) including Freight, Cross-Border and Supply Chain Management to drive overall operational excellence.

Key responsibilities:

· Lead ongoing monitoring of key operational metrics and data reporting

· Drive performance improvement based on key operational metrics

· Develop and implement internal quality control standards

· Analyse existing operational flows and highlight potential process weaknesses

· Evaluate and execute process improvement opportunities

· Work closely with BUs to ensure adherence to operational processes and SLAs

Requirements:

· 5 years of working experience in similar position

· Previous exposure to e-commerce and/or logistics sector(s) highly advantageous

· High level of resourcefulness and adaptability

· Collaborative and data-driven approach to problem solving

· Able to work independently and with high attention to detail

· Language proficiency in both English and Chinese (reading, writing and verbal) is a must for liaison with HQ and Chinese speaking stakeholders

· Proficiency in Microsoft Excel and PowerPoint

Assistant Manager / Manager, Quality Assurance

About CorDx:

CorDx is a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,000 employees across the world, serving millions of users in over 100 countries.

CorDx is transforming the global diagnostics industry with innovative R&D solutions, a vertically integrated supply chain, and manufacturing footprints in the United States and around the world.

With nearly two decades of IVD experience, CorDx is a leader in IVD research and development, manufacturing, and supply chain. Our proprietary line of rapid diagnostic products is recognized by families and medical professionals for reliability, affordability, and rapid results.

CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.

Job Responsibilities

• Implement, manage and constantly improve the company’s quality management system, including but not limited to the IVD products and equipment;
• Regularly perform internal audits, compile audit reports, problem analysis reports, improvement proposals, and monitor the rectification plan and its implementation;
• Lead and Participate in the internal audits and management reviews of the company's quality system as key member of company's quality department;
• Manage the system and documents of company’s quality management system, including but not limited to the IVD products and equipment;
• Be specifically responsible for the IVD equipment quality management system;
• Statistical analysis of IVD equipment quality data, and draft reports and corrective and preventive measures;
• Update quality standards, laws and regulations and publish company quality policy;
• Establish collaborative and cooperative working relationship with key opinion leaders and the regulatory bodies;
• Collaborate with cross-functional teams to meet projects goals with overall organizational objectives.
• Any other ad-hoc duties or projects as required by the management team.

Qualifications:

• Quality system related training and internal auditor training;
• Familiar with ISO9000 & ISO13485 quality management system and certification work, experience with successful case(s) will be preferred;
• Familiar with GMP and medical device industry standards and specifications;
• Strong quality management system knowledge and capabilities;
• A bachelor's degree with 7 years of relevant experience, a master's degree with 3 years of relevant experience, or a doctorate degree with at least 1 year of relevant experience. Others are welcome to apply.
• Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, Immunoassay etc;
• Familiar with IVD product development and commercialization life cycle;
• Systematical project management, good planning, execution and timely communication. Good presentation skills.
• Majoring in biology, medicine, laboratory science, immunology, pharmacy or quality engineering are preferred;
• Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player;
• Meticulous and strong sense of responsibility; able to handle stress and tight schedule;

How to Apply:

• Please send a comprehensive resume, a cover letter (if applicable), along with your current and expected salary to foongying@cordx.com or click to submit here @ My careerfuture.
• We regret that only shortlisted candidates will be contacted

Responsibilities:

• To ensure supply chain processes comply with national regulatory compliance and meet international benchmarks and standards.
• Leads in addressing quality assurance issues in the production department
• Conduct walk by inspections and give real time feedback to team leaders and operators.
• Conduct regular internal audits, surveillance and inspections.
• Complete internal audits on time
• Update Quality manual
• Develop QA plans by conducting hazard analysis, identify Critical Control Points, implement preventive measures, establishing critical limits, monitor procedures, corrective actions and verification procedures.
• Provide advices on and propose in-house quality procedures, standards, and specifications to management.
• To assure consistency in product safety and quality by developing and enforcing Good Manufacturing Practice, validating existing processes, providing documentation and staff management.
• To work closely with Sales, Marketing, and Customer Service Departments to analyse customer complaints and feedbacks, and act as a catalyst for change and improvement in product quality to meet changes in existing customer’s requirements.
• Ensure ISO standards are implemented by all QC Executives (Food Technologist), team leaders and operators.
• To provide leadership and guidance, orientate, train, and guide QC / QA staff and other subordinates on their job.
• Work with Production and QC to establish SOP / WI for use in training staff, like new workers

Requirements:

• At least 3 years and above experience in a similar role in a food production company
• Mastery of FSSC 22000, ISO, HACCP, and Halal standards
• Experience in Food Safety regulatory auditing will be an added advantage
• Self-driven, self-discipline, good team worker
• Self-management (stress management, work organization, time management)
• Willingness and flexibility to work in special projects requiring his/her skills
• Able to communicate fluently in Mandarin and written Chinese

1. Leadership and Management: Quality Manager requires strong leadership committed to quality improvement. Leaders set the vision, goals, and strategies for TQE implementation, allocate resources, and provide support and guidance to employees.
2. Quality Planning: This involves setting quality objectives, identifying customer requirements, establishing processes to meet those requirements, and developing plans to achieve continuous improvement.
3. Training and Education: Quality Manager emphasizes the importance of training and educating employees at all levels of the organization to ensure they understand quality concepts, tools, and techniques, and can contribute effectively to improvement efforts.
4. Quality Control: Monitoring and measuring processes and outputs to ensure they meet quality standards. This may involve statistical process control, inspections, audits, and other quality control techniques.
5. Quality Improvement: Identifying opportunities for improvement, analyzing root causes of problems, implementing corrective and preventive actions, and continuously striving to enhance processes and products/services.
6. Customer Focus: Understanding customer needs and expectations, gathering feedback, and using it to improve products/services and enhance customer satisfaction.
7. Supplier Management: Working closely with suppliers to ensure they meet quality standards and deliver high-quality inputs, materials, and components.
8. Employee Involvement and Empowerment: Encouraging and empowering employees to participate in quality improvement efforts, share their ideas and suggestions, and take ownership of quality-related activities.
9. Measurement and Analysis: Collecting and analyzing data to track performance, identify trends, measure progress toward quality objectives, and make data-driven decisions.
10. Continuous Improvement: Establishing a culture of continuous improvement where all employees are encouraged to seek opportunities for improvement, experiment with new ideas, and learn from successes and failures.
11. Communication and Collaboration: Facilitating open communication and collaboration across departments and levels of the organization to ensure alignment of quality goals and efforts.
12. Documentation and Documentation Control: Maintaining accurate records of quality-related activities, processes, and outcomes, and ensuring proper documentation control to prevent errors and ensure compliance with quality standards and regulations such as ISO 9001-2015.

JOB DESCRIPTION:

• Responsible for day-to-day business data management and regular business report preparations, which includes SAP material master maintenance, data integrity checking and statistics.
• Daily monitoring of basic system health and to flag out any inconsistency in API/System functions when found/reported.
• Daily monitoring of system backend jobs and ensure transactional data are interfacing in healthy state with external/internal system.
• To support Business Analytics, extracting and reorganizing original data, dealing with data related issues with other departments.
• Responsible for data preparation, data mining, to create/identify opportunities through analytics, to optimize business objectives.
• Communicate findings and insights to relevant stakeholders in order to assist Manager in making data-driven decisions in KPI assessments.
• Drive continuous improvements /optimization of campaign performance tracking report with business while complying to A*STAR policies.

REQUIREMENTS:

• Bachelor's Degree or Diploma (with at least 5 years or more relevant experience), preferably Business Analytics, Information systems or Computer Science.
• Strong analytical skills, with experience solving problems using data and providing practical business insights.
• Self-Starter with a strong sense of urgency.
• Aptitude to challenge the status quo, think outside the box, and question what has been done.
• Comfortable with dealing with sets of data points from different sources.
• Qualities of matured thinking, dependable and requires minimum supervision.
• Excellent communication skills (oral and written).

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

The essential responsibilities include:

• Manage, motivate, coach, and develop the Assembly staff.
• Ensure overall adherence to safety practices.
• Review the quality of products including all incoming shipments.
• Performance manage team members, giving direction and feedback to aid good performance
• Check and verify customers' complaints
• Handle customers' product warranty & repair issues via phone calls and emails.
• Fixing and repairing minor defects of products.
• Prepare documents for customer service items to return to retail stores.
• Perform any other tasks as and when assigned

Formal Education & Certification

• Secondary Education or relevant experience

Knowledge & Experience

• Minimum 5 years of relevant experience managing a team in QC setting
  Experience in supervising different shifts
• Proven ability to effectively coach & monitor QC assistants to lead and achieve desired performance goals & objectives
• Good understanding of budgeting and resource allocation
• Experienced in and a desire to lead change and work with others to implement new practices, roles, and structures

Personal Attributes

• Ability to strategically plan for the future, combined with the ability to deliver on details
• A team leader and analytical thinker with strong administrative, decision-making, time management and organizational skills
• Good interpersonal skills – ability to work and interact with all levels of management and stakeholders
• Motivational skills and an ability to supervise and lead a team
• Positive attitude
• Strong problem-solving and conflict-resolution skills
• Ability to work effectively under pressure
• Good active listening skills
• High level of initiative and integrity

Careers that Change Lives

We are a learning culture. An inventive and collaborative group. We are dedicated to making sure that every patient gets the best product — when they need it. We have strong ties to our local communities. Our vibrant employee communities respect and value individual experience and perspective as we aim to improve lives and the access to healthcare.

A Day in the Life

• Leads the QA function to ensure quality system development and compliance with FDA's Quality System Regulation, 13485, MDD / EU MDR, and other quality requirements.
• Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Provides guidance and coaching to all direct reports, includes establishing individual performance & development objectives and plan
• Leads the strategic planning the functional team in driving continual improvement and effectiveness of Quality Operations and Quality Systems.
• Establishes quality programs and initiatives to ensure products and assemblies are developed and manufactured in accord with applicable requirements.
• Leads and/or supports initiatives at Medtronic Singapore and across sites to ensure effective quality reporting, quality systems and quality improvement efforts and Customer-Focused Quality; supervise the Quality System implementation. Supports the implementation of engineering projects, including design transfers and provide management oversight in establishing the quality system requirement at other facilities and Medtronic projects.
• Act as the CAPA board chair to ensure effective CAPA process and drive the development of systems and processes for the identification, analysis, correction, and prevention of quality issues.
• Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
• Works with Singapore and platform leadership team members in developing long and short-term business goals and strategies.
• Represents Singapore on OU/ enterprise Quality Leaders team meeting, collaborate with peers across all sites and Operating Units for global quality initiatives and works closely with peers on similar quality concerns between MDT sites.

Qualifications

Must Have

• Requires a Bachelor’s degree minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years prior relevant experience.

Your Profile

• Minimum of 5 to 7 years management expertise in the Pharmaceutical, Medical Devices or any highly regulated manufacturing industry.
• Overall operational and financial acumen, Business and Project Management skills and experience a plus.
• Familiar with Quality System requirement and knowledge of Quality System Regulations and ISO.
• Broad management knowledge to lead a team and have a prior experience in manufacturing environment and Quality function.

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

JJIM aims to cultivate industry-leading capabilities that enhances competitiveness, aligned with HCP needs, and ultimately deliver improved outcomes for patients.

Under this umbrella, the CX& CD CoE aims JJIM to be the preferred partner for HCPs. The vision of this CoE is to deliver industry-leading, data-driven engagement with HCPs that is personalised, orchestrated and seamless across channels. Integrating Content Strategy and Operations closely with Content Approvals is a key enabler. This synergy between content and compliance ensures omnichannel content delivery with the highest quality and speed without compromising risk.

Tasked with the role of improving our content compliance approval workflow, this position will have a significant opportunity to directly drive enterprise growth and efficiency.

*Please note that the role will require 20% travel due to the regional portfolio.*

Key Responsibilities

The Content Compliance Manager will be responsible for supporting the optimized workflow and general management of the copy approval process for advertising and promotional materials and implementing modern practices of approval for content such as claims, components and modular content.

1. Copy Approval Process and Approval Framework:

Enables, advises, and implements risk framework for review and approval of ad/promo materials, claims, components, and modular content in APAC markets. Should be able to significantly reduce time of approval without compromising on risks.

2. Process Implementation:

Ensures optimized workflow is followed in markets with clear adoption plan. Ongoing partnership and communication with Compliant Communications Managers and cross-functional stakeholders (Regulatory, Medical, Legal, HCC, Data Privacy, ITS, Communications, Marketing) in order to achieve business objectives.

3. Technology / system expertise:

Will be expert on copy approval workflow and digital asset management system, provides guidance and support to the current team. Pro-actively collaborate with the business technology team to identify and implement technology optimization for reference, end to end workflow.

4. Cross functional squad delivery teams:

Building, leading and being part of cross-functional teams to deliver on content transformation initiatives. Support the adoption of key initiatives for cross-functional brand teams in the organization.

5. Collaborated with stakeholders beyond APAC:

Collaborate with global and cross-regional teams within JJIM to ensure best practices are identified and transferred to APAC.

Qualifications

At Johnson & Johnson, we value diverse experience, and we look for potential in candidates to move beyond the position they’re hired for. Below is a list of the top 4-5 skills and competencies that are important for this position, which candidates can either bring to this role, or where candidates may be able to learn and grow whilst in the role (this will be dependent on position).

Skills & Competencies

· Content Approvals & Change Management: Ability to lead large scale transformational change in Content approvals.

· Influencing & Stakeholder Management: Ability to influence, drive decisions and outcomes across multiple levels of the organisation, especially with HCC. Ability to work cross-functional teams.

· Strategic thinking and ability to translate strategy into actionable plans: Ability to distill insights into clear strategies aligned to our Vision, translate these into actionable plans (RACI) that drive business outcomes.

· Communication Skills: Excellent verbal, written, visual and facilitation communication skills.

Experience or qualifications that are critical to this position.

· Pharmaceutical experience. Medical, Regulatory or Legal experience, especially in content approvals

· Experience leading workflow optimization

· Understanding of new content practices such as modular content

· Understanding content, and content approvals workflows

· Understanding of approval systems in Veeva promo mats.

· Experience working in an Agile environment (desirable)

Job Descriptions

- Perform hands on pest control work on customers' sites

• Attend to Clients' complaints on pest issues and understand the potential causes of pests' activities

• Conduct on-site routine reviews to Client's premises to check on the quality of the technical team and ensure Company's SOP and Protocol are followed thru' by technicians.

• Prepare ad-hoc / monthly formal reports to clients with recommendations for remedial actions for enhanced protection of their premises.

• Attend meetings with technical team as well as NEA inspectors on site.

• Do presentations during meetings in front of customers/NEA officers to review pest issues

• Implement on work plan, Risk Assessment, Safe Work Procedures, hygiene standards to ensure compliance with Workplace Safety & Health Environment.

• Maintain mandatory records and other documentations for Bizsafe Level 3 Certification.

• Strong knowledge on General pests & safety regulations will be an added advantage.

• Proficient in MS Office.

• Ability to lead

• Good command of English

• Minimum 4 years experience in the relevant field.

• NEA Pest Management Licence preferred

• Must have Class 3 driving licence

• Able to start work immediately or short notice.

• Must be prepared to be on standby duty 24/7 even on weekends or public holidays

Job Summary :

We are looking for a Test Program Manager :

Requirements:

• 20 years of experiences in Banking Domain
• Experiences in Test Program Management Skills
• Experience in Investment Banking, Wealth Management Domain
• Experience in Temenos T24 Implementation Testing
• Excellent Communication and Stakeholder Management Skills

Qualification:

• Degree in related Discipline

JOB DESCRIPTION:

• Responsible for day-to-day business data management and regular business report preparations, which includes SAP material master maintenance, data integrity checking and statistics.
• Daily monitoring of basic system health and to flag out any inconsistency in API/System functions when found/reported.
• Daily monitoring of system backend jobs and ensure transactional data are interfacing in healthy state with external/internal system.
• To support Business Analytics, extracting and reorganizing original data, dealing with data related issues with other departments.
• Responsible for data preparation, data mining, to create/identify opportunities through analytics, to optimize business objectives.
• Communicate findings and insights to relevant stakeholders in order to assist Manager in making data-driven decisions in KPI assessments.
• Drive continuous improvements /optimization of campaign performance tracking report with business while complying to A*STAR policies.

REQUIREMENTS:

• Bachelor's Degree or Diploma (with at least 5 years or more relevant experience), preferably Business Analytics, Information systems or Computer Science.
• Strong analytical skills, with experience solving problems using data and providing practical business insights.
• Self-Starter with a strong sense of urgency.
• Aptitude to challenge the status quo, think outside the box, and question what has been done.
• Comfortable with dealing with sets of data points from different sources.
• Qualities of matured thinking, dependable and requires minimum supervision.
• Excellent communication skills (oral and written).

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

Quality and Supply Chain Manager

Job Description

Nuevocor is a pre-clinical stage biopharmaceutical company dedicated to developing genetic medicines to treat the underlying cause of genetic cardiomyopathies. Backed by an international syndicate of reputable venture capital firms, it will focus on advancing its pipeline of programs to clinical trials. It will also leverage its platform technology, underpinned by a deep understanding of cardiac mechanobiology, to discover and develop therapies for multiple cardiomyopathies.

Nuevocor’s Singapore site is seeking to hire a Quality Manager to join our Tech Ops department to support advancing our therapeutic candidates forward. Reporting to the Head of Tech Ops, you will play a key role in setting up, managing and maintaining our Quality Management System and processes in compliance with relevant standards and regulatory requirements. You will be part of a dynamic and fast-paced biotech working environment.

Responsibilities

· Implement, manage and maintain a compliant GxP Quality Management System, encompassing the aspects of Quality Risk Management, CAPA, Deviations, Change Control, Quality Documentation.

· Conduct internal and external audits, including at sub-contractor facilities and processes.

· Provide on-site support at CDMOs for manufacturing production.

· Manage supply chain of materials across sites of CDMOs, CROs and clinical trial sites.

· Prepare Quality documentation and agreements.

· Review GxP protocols, reports and Standard Operating Procedures to ensure compliance.

· Develop and deploy the GxP quality assurance strategy as approved by senior management.

· Reports all critical and relevant quality and compliance issues to management.

· Ensures quality assurance expertise is available and effective for GxP operations.

· Provide Quality Assurance review and disposition of GxP products, as appropriate.

· Acting as a point of contact with regulatory authorities.

· Support the development and harmonization of quality standards and processes.

· Maintain good relationships with regulatory agencies.

· Ensure that all personnel training, investigations, actions, CAPAs are completed on time.

· Assists in the development and maintenance of training program.

· Lead and assist in the development of SOP and procedures to support GxP functions.

Requirements

· Scientific degree in Pharmaceutical Sciences or related fields.

· 5-10 years experience in GxP particularly GCP and GMP areas and other regulations applicable in the Pharmaceutical Industry.

· Experience with supply chain and shipping, preferably with biologics materials.

· Knowledge of drug development regulations and implementing GxP in Gene Therapies

· Actively able to manage multiple projects to meet timelines, while maintaining compliance.

· Ability to work in teams with diverse cultural and professional backgrounds

· High standards in documentation and record keeping.

· Strong interpersonal and organizational skills

· Strong collaboration and team working skills

· Excellent writing and verbal communication skills

· Excellent problem solving ability

· Ability to multitask

· Possess a mindset of no job too big or too small

Nuevocor is an equal opportunity and equal benefits employer. All qualified applicants will receive consideration for employment. Position is commensurate with experience.

Interested candidates, please submit a CV and cover letter to tinyurl.com/nuevocorcareer

This role will Ensure products manufactured by contract manufacturer meet all defined specifications and are developed and manufactured in compliance with all applicable quality system requirements and provide leadership to work with different Medtronic entities and set up the strong relationship to support the implementation of Quality Systems for the new entity in implementing China localization strategy.

Primary Responsibilities

• Set up the Quality Systems to it meets Singapore, China and requirement countries requirement.
• Establishes quality programs and initiatives to ensure products and assemblies are developed and manufactured per applicable requirements.
• Establish strong supplier control and Quality oversight over suppliers and Medtronic entities.
• Driving continual and preventive improvement of quality management systems in supporting the conformity of process and product quality.
• Supports and develops systems for the identification, analysis, correction, and prevention of quality issues.
• Contributes quality expertise to product development and manufacturing transfers including working closely with suppliers to implement robust manufacturing processes and Quality oversight.
• Oversees and lead key quality systems processes to ensure its effectiveness which includes Design Control, Supplier Controls, Quality Planning, Document Controls, Training, Audits, Change Controls, Nonconformance CAPA, Manage External Requirement, etc.
• Leads the site audit readiness and manages, conducts and coordinates external (Singapore, China, ISO, etc.) audits.
• Take preventive actions to improve the compliance and effectiveness of Quality Management Systems by proactive learning from other sites and best practices from the industry.
• Provides QA support, participate and collaborate with Operating Units improvement program
• Works with local management team members in developing long and short-term quality goals and strategies.
• CAPA board memberParticipate in CAPA and board meetings to review the trending of all input sources and determine if any further action is needed
  Perform review on the CAPA investigation, action plan and effectiveness to determine if CAPA process requirement are fulfilled.
• Represents the new entities to collaborate with peers across all Operating Units for global quality initiatives and works closely with peers on similar quality concerns between Medtronic sites

Qualifications - External

Must Haves

• Bachelors Degree required
• Minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience