Associate Director PV Strategy and Inspection Management
Location: Europe/Middle East/Africa, United Kingdom, Reading, Berkshire Work Location: Hybrid
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’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID®. Science is our passion; care is our talent.
Who We Are
Our 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.
Role Reports To
Director Global Consumer Bioresearch QC
What will you do
The 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. The position will drive the strategic design, implementation, and execution of an effective and proactive external inspection readiness and management framework, serving to optimally prepare and support the Kenvue R&D/Medical Safety organization for external inspections across the company. The Lead will provide PV strategic direction before, during, and after external inspections (including communication with Regulatory Authorities), and develop a culture of inspection and audit preparedness by monitoring outcomes and trends, proactively sharing insights. This key global cross‑functional strategic role drives continued and enhanced compliance across Kenvue, managing complex compliance issues and interfacing with senior leadership on an ongoing basis.
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 overseeing inspection commitments to ensure 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.
Decision-Making and Problem Solving
Resolves strategic business/regulatory issues with franchise, corporate and business group leaders. Acts as a global spokesperson and negotiator with Regulatory Authorities.
Independence/Autonomy
Operates with minimal guidance from the supervisor and is expected to lead and be proactive in setting priorities to achieve BRQC goals and objectives.
Reporting Relationships
Reports directly to the Head BRQC, Kenvue, and works closely with Kenvue Medical Safety and Head Medical Safety Performance and Compliance.
Responsibility for Others (If Applicable)
Champions coaching and mentoring for success in the PV Inspection Management team and across the entire BRQC organization when necessary.
Working Relationships / Interfaces
* Interfaces with Health Authorities during the inspection/audit process.
* Represents BRQC on appropriate management and leadership boards. Incumbent will have contact with individual employees and all levels of management up to the Chief Medical Officer and Chief Quality Officer, manufacturing functions, R&D Operations functions, HCC, Finance, Corporate and the Law Department, etc.
* Works very closely with other BRQC functions to influence or execute strategies.
* Interacts with quality professionals within QHS and with quality professionals in third‑party organizations and worldwide Health Authority officials as needed.
Qualifications
* At least 8 years of experience in relevant pharmacovigilance or quality setting with demonstrated leadership working on complex compliance topics.
* Knowledge of worldwide Pharmacovigilance and other applicable compliance regulations and guidelines (e.g., GMP, GCP, GLP, IT).
* Experience with facilitating PV or other GxP regulatory inspections (front‑room) and supporting submissions during inspections (back‑room) and logistics.
* Strong understanding of inspection methodologies and quality assurance principles, with a proven track record of effective investigation and remediation of non‑compliance within complex organizations.
* Excellent written and verbal communication skills, demonstrating effective influencing across all levels of an organization.
* Regulatory Authority experience is desirable.
* Bachelor’s degree required; Master’s in a related field or advanced degree desirable.
Related Experience
Experience with Regulatory Authorities is a significant asset.
Working Conditions / Travel Requirements
Travel requirements: approximately 30% global travel will be required.
What’s In It For You
* Competitive Benefit Package
* Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!
* Learning & Development Opportunities
* Employee Resource Groups
* This list could vary based on location/region
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. If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.
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