Associate Director PV Strategy and Inspection Management
Associate Director PV Strategy and Inspection Management What we do
At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we are 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.
Who We AreOur global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact 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. For more information, .
Director Global Consumer Bioresearch QC
LocationEurope/Middle East/Africa, United Kingdom, Reading, Berkshire
Work LocationHybrid
What you will doAssociate Director, Pharmacovigilance (PV) Strategy and Inspection Management
What will you doThe PV Strategy and Inspection Management Lead is responsible for guiding the R&D and Medical Safety business partners through the complexities of PV regulatory requirements.
This position will drive the strategic design, implementation and execution of an effective and proactive external inspection readiness and management framework. This framework will serve to optimally prepare and support the Kenvue R&D/Medical Safety organization for external inspections company wide from Regulatory Authorities and third‑party partners with whom Kenvue co‑markets products.
In the role, the Lead will provide PV strategic direction before, during and after external inspections (including strategic direction for communication with Regulatory Authorities), and develop a culture of inspection and audit preparedness by monitoring external industry and internal Kenvue inspection outcomes and trends, proactively sharing insights.
This is a key global cross functional strategic role that drives continued and enhanced compliance across Kenvue. The incumbent will manage company wide complex compliance issues interfacing with senior leadership on an ongoing basis.
It is expected that approximately five inspections from various global Regulatory Authorities will occur each year and two external audits will take place at the country office.
Principal Responsibilities- Providing expert strategy, direction, and advice to R&D/Medical Safety business partners related to PV regulatory requirements, audit scope, risk assessment and annual schedule development.
- Leading Bioresearch Quality & Compliance (BRQC) PV inspection support strategy, acting as the primary front‑room host for inspections and leading the organization in the preparation, conduct, and post‑inspection activities for PV inspections globally.
- Providing strategic direction for communication with Regulatory Authorities post‑inspection, including review and input to inspection observation responses prior to submission and the oversight of inspection commitments ensuring documented evidence of completion.
- Monitoring external industry and internal Kenvue inspection outcomes and trends. Proactively sharing insights to develop and implement effective inspection and audit readiness measures.
- Supporting Regulatory Compliance in the conduct of Special Investigations where specific PV expertise is needed.
- Ensuring timely submission of inspection‑related information into company databases.
- Providing input to BRQC PV Audit Strategy and collaboration audits to support inspection readiness.
- Providing strategic leadership, people management, coaching, and mentoring to the PV Inspection Management Team and broader BRQC colleagues, Business Partners, when necessary.
Resolves strategic business/regulatory issues with franchise, corporate and business group leaders. Global spokesperson and negotiator with Regulatory Authorities.
Independence/AutonomyOperates with minimal guidance from…
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