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Job Description
***PLEASE SEND YOUR CV IN ENGLISH***
General position summary:
Associate Director, Regional QA Lead (LATAM & Central America) is a leader within International Quality organization who holds responsibility in ensuring quality compliance in LATAM and Central American Vertex Affiliates. This position holder has an oversight of the distribution network, including distribution partners, and will lead quality oversight initiatives associated with LATAM and Central American region. Associate Director, Regional QA Lead will also ensuring ongoing maintenance of the licenses, leading regulatory inspections, and supporting International Quality in wider regional or global projects.
This Position Reports to: Director, Market Quality
This is a hybrid role based in Sao Paulo, Brazil.
Key Responsibilities:
LATAM & Central American Regional activities:
Key technical knowledge and skills:
Minimum qualifications:
Master’s degree and relevant work experience, or Bachelor’s degree in a scientific or allied health field (or equivalent degree) and significant years of relevant work experience.
Qualifications:
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
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At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.
We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As Associate Director Clinical QA, you will be trusted to provide input and assist in establishing the vision and strategic direction for Clinical R&D activities in the R&D, QA, GCP, GLP and Medical Safety Operations Groups at our Main Campus in Fort Worth, TX.
POSITION PURPOSE
In this role, a typical day will include:
WHAT YOU'LL BRING TO ALCON:
PREFERRED QUALIFICATIONS:
HOW YOU CAN THRIVE AT ALCON:
ATTENTION: Current Alcon Employee/Contingent Worker
If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.
Find Jobs for Contingent Worker
Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.
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Job Description
Director of Quality Cell.& Gene, Manufacturing Systems is accountable for ensuring Operational Systems related improvements and projects are planned, prioritized, and executed in a systematic manner. The role is accountable for leading/supporting continuous improvements of quality operations processes, development of digital roadmaps including Quality user requirements, details of Quality process flows and assuring realization of such requirements into systems and procedures.
The role provides Quality oversight to assure that the Quality requirements are appropriately built in and executed within the key Vertex initiatives such as commercial launches, technology projects and efficiency driving measures.
The role will be highly cross-functional and will require meticulous planning, resources allocation and effective partnering with quality and other stakeholders – MSAT, DTE, QC – to participate in Cell and Gene therapies program oversight and associated governance.
Key Duties & Responsibilities
Knowledge and Skills:
Education and Experience:
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
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(The role is only open to candidates based in Poland)
Job Overview
This role is assigned to designated Delivery Unit(s), country/countries, sponsor(s), business units(s), and/or specific tasks as defined by the line manager (LM). Contributes to the development and is responsible for the implementation of specific quality improvement initiatives as agreed with the relevant Head(s) of assigned business lines. Provides advice and supports relevant key stakeholders with regards to quality control, risk assessment, risk management, and corrective/preventive actions.
Essential Functions
• Contributes to the development, and supports implementation of the Quality Management Plan within the scope of the assignment this will include: Planning and executing the Quality Management activities. Risk identification and assessment through data review and quality control processes. Providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement. Supporting the assigned business line management and staff to enhance effectiveness in project delivery.;
• Cooperate closely with the relevant business lines and other stakeholders, support maintaining focus on quality in project delivery.
• Provides advice and support to teams within the assigned business line on all aspects of Good Clinical Practice (GCP) compliance.
• Works in close cooperation with teams to manage non-compliance, quality issues
• Assist in planning corrective/preventive actions, as applicable according to Standard Operating Procedures (SOPs).
• Informs the assigned business line and Quality Assurance of quality issues according to SOPs.
• Works closely with Quality Assurance and assigned business staff in case of suspected misconduct, as required by the applicable SOPs.
• May provide assistance during audits and regulatory inspections to the teams to the extent agreed with the line manager, as required by the applicable SOPs.
• Acts as the primary contact for Quality Assurance on quality matters – on the level of the assignment, attend meetings/teleconferences.
• Prepares periodic reports to business lines on quality related matters, risk assessments and specific quality improvement initiatives.
• Manages staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work, appraising performance and guiding professional development, rewarding and disciplining employees, addressing employee relations issues and resolving problems. Approve actions on human resources matters.;
• Upon agreement with the Head of relevant business line: Performs any other reasonable tasks as required by the role.
Qualifications
• Bachelor's Degree Req
• Typically requires 5-7 years of prior relevant experience.
• Requires deep knowledge of one or more related job areas typically obtained through advanced education combined with experience.
• Sound working knowledge of relevant terminology, International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), applicable regulatory requirements, quality management processes.
• Excellent organizational, interpersonal and communication skills.
• Excellent judgement and decision-making skills.
• Demonstrated leadership and line management skills.
• Excellent influencing and negotiation skills.
• Strong computer skills including Microsoft Office applications.
• Excellent problem-solving skills.
• Demonstrated ability to work in a matrix environment.
• Ability to lead and motivate a clinical team also required.
• Ability to travel within the region/country.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients.
• Fluent in English.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
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Your new company
Senior Tax Manager required in the Tax Assurance and Risk Management team, by a highly respected Accountancy Firm located in Birmingham. The client is a global accountancy and business advisory firm, a recognised leader in providing assurance and support to clients, and specialises in a range of tax, audit, and assurance matters. The Tax Assurance and Management team is the fastest growing of its kind, making this an exciting opportunity and a great time to join.
Your new role
The main focus of this role is on its various and exciting clients, therefore excellent communications skills are a must - especially the ability to make complex concepts easily understandable for a variety of audiences. As a Senior Manager, you will be looking after a portfolio of clients, managing their project delivery, and being their key point of contact, while also recognising business opportunities where possible. Other responsibilities will also include supporting other Senior members of the team and the Partners, while also managing junior colleagues providing training where necessary.
What you'll need to succeed
To successful candidate will already be CTA/ACA qualified (or equivalent), with demonstrable experience of Tax Assurance and Risk Management work. The ideal candidate will also possess great communication skills, with the ability to communicate effectively with clients, build and maintain long-lasting relationships, and train staff accordingly. There will also be a desire to achieve success and push further growth.
What you'll get in return
In return, you will be working within an experienced yet still expanding team, and gain access to a range of truly exciting clients. The firm offer a highly competitive salary, reviewing remuneration regularly, and support when required. The firm also offers a range of flexible lifestyle benefits to choose from upon starting.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.
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