Come work at the forefront of science - and help the brands you grew up with grow and evolve into the next generation.
Job Description - Pharmacovigilance Auditor - Lead Specialist (2407025369W)
Kenvue is currently recruiting for a:
BioResearch Q&C Pharmacovigilance Auditor - Lead Specialist
This position is based at our High Wycombe office (hybrid working policy) and requires overnight travel, nationally and internationally, up to 50%.
Who We Are
At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSON’S and BAND-AID that you already know and love. Science is our passion; care is our talent. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact the life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours.
What you will do
1. Independently lead the planning, conduct and reporting of BRQC routine and non-routine audits of activities, data, internal facilities and processes in GVP to verify adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements.
2. Conduct non-routine audits including Due Diligence, for cause audits, cross-functional, system/service provider audits as defined by the scope.
3. Support other auditors in planning, conduct and reporting of audits.
4. Ensure the relevant standard procedures, diagnostic tools, and audit plans and scope are fully understood and applied in audit activities.
5. Participate in regulatory inspections in core and supporting roles.
6. Contribute to the overall PV Quality & Compliance strategy.
7. Assist in preparation and delivery of training materials.
8. Advise and contribute to coaching, including audit outcomes and Corrective and Preventive actions.
9. Complete training requirements in a timely manner to ensure inspection readiness at all times.
10. Take an active role in projects as assigned by supervisor and interact with key stakeholders as appropriate.
11. Meet priorities, checkpoints and timelines for all aspects of work and projects to achieve adequate progress.
12. Provide expertise and knowledge to others in BRQC, Business Partners and the core business sector on quality and compliance processes/procedures.
13. Interpret and apply regulations/policies to issues of moderate complexity, when required.
What we are looking for
1. A minimum of a Bachelor’s Degree is required.
2. A minimum of 5 years of experience in pharmacovigilance, quality and/or compliance is required.
3. Comprehensive knowledge of the drug development process, applicable regulations (GxP), R&D practices, and scientific and quality terminology is required.
4. Expertise in GVP regulations and one or more specific compliance disciplines (GLP, GCP) preferred.
5. Knowledge of procedural and records management requirements in a regulated industry preferred.
6. Prior pharmaceutical, consumer personal products and quality/compliance related experience preferred.
7. Must have excellent communication skills and be fluent in written and spoken English.
8. Must be a team player, organized and detail oriented, and possess sound problem-solving and good negotiating skills.
9. Must be proficient in Microsoft Office applications and possess a Quality mindset.
What’s in it for you
1. Paid Company Holidays, Paid Vacation, Volunteer Time & More!
2. Learning & Development Opportunities.
3. Employee Resource Groups.
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location
Europe/Middle East/Africa-United Kingdom-England-High Wycombe
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