At a Glance
- Tasks: Lead pharmacovigilance strategy and manage inspection readiness for global compliance.
- Company: Join Kenvue, part of Johnson & Johnson, known for iconic brands like NEUTROGENA® and TYLENOL®.
- Benefits: Enjoy competitive pay, paid holidays, volunteer time, and summer Fridays!
- Other info: Hybrid work model with opportunities for global travel and career growth.
- Why this job: Make a real impact in healthcare while working with a passionate global team.
- Qualifications: 8+ years in pharmacovigilance or quality, strong leadership, and communication skills required.
The predicted salary is between 70000 - 90000 £ per year.
Kenvue is currently recruiting for an Associate Director PV Strategy and Inspection Management.
What we do
At Kenvue, we realise 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.
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 – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours.
Role reports to: DIRECTOR GLOBAL CONSUMER BIORESEARCH QC
Location: Europe/Middle East/Africa, United Kingdom, Reading, Berkshire
Work Location: Hybrid
What you will 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. 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 companywide 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 companywide 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.
- Monitor external industry and internal Kenvue inspection outcomes and trends. Proactively sharing insights, to develop and implement effective inspection and audit readiness measures.
- Support Regulatory Compliance in the conduct of Special Investigations where specific PV expertise is needed.
- Responsible for ensuring timely submission of inspection-related information into company databases.
- Provide input to BRQC PV Audit Strategy and collaboration audits to support inspection readiness.
- Provides 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. Global spokesperson and negotiator with Regulatory Authorities.
Independence/Autonomy:
Operates with minimal guidance from supervisor. Expected to lead and be proactive in the setting of priorities to achieve BRQC goals and objectives.
REPORTING RELATIONSHIPS:
Reports directly to the Head BRQC, Kenvue. 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 & across the entire BRQC organization if necessary.
WORKING RELATIONSHIPS/INTERFACES:
Interfaces with Health Authorities during the inspection/audit process. Represents BRQC on appropriate management and leadership board(s). Incumbent for this position will have contact with individual employees and all levels of management up to the Chief Medical Office and Chief Quality Officer, manufacturing functions, and 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. Interacts as appropriate with quality professionals in third party organizations and worldwide Health Authority officials as needed.
Qualifications - External
What we are looking for:
- Requires at least 8 years of experience in relevant pharmacovigilance or quality setting with demonstrated leadership working on complex and significant compliance topics. Must have knowledge of worldwide Pharmacovigilance & other applicable compliance regulations and guidelines (e.g. GMP, GCP, GLP, IT).
- Must have experience with facilitating PV or other GxP Regulatory Inspections (front room) and supporting submissions during inspections (back-room) and logistics.
- Requires a strong understanding of inspection methodologies and quality assurance principles, with a proven track record of effective investigating and remediating non-compliance within complex organizations.
- Excellent written and verbal communications skills, demonstrating effective influencing across all levels of an organization.
- Regulatory Authority experience is desirable.
- Bachelor’s degree is required. Masters in related field, advanced degree desirable.
RELATED EXPERIENCE:
Experience with Regulatory Authorities is a significant asset.
WORKING CONDITIONS/TRAVEL REQUIREMENTS:
Travel requirements: approx. 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, colour, 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.
Associate Director PV Strategy and Inspection Management in Reading employer: KENVUE
Kenvue is an exceptional employer that prioritises a culture of care, innovation, and collaboration, making it an ideal place for professionals seeking to make a meaningful impact in the field of pharmacovigilance. With a hybrid work model based in Reading, Berkshire, employees benefit from a competitive package that includes generous paid time off, learning and development opportunities, and a supportive environment that values every voice. Join a global team dedicated to improving everyday lives through science and care, where your contributions are recognised and growth is encouraged.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director PV Strategy and Inspection Management in Reading
✨Tip Number 1
Network like a pro! Reach out to current or former Kenvue employees on LinkedIn. Ask them about their experiences and any tips they might have for landing the Associate Director role. Personal connections can give you insights that job descriptions just can't.
✨Tip Number 2
Prepare for the interview by diving deep into Kenvue's values and products. Show us how your experience aligns with our commitment to care and innovation. Bring specific examples of how you've tackled compliance challenges in the past—this will make you stand out!
✨Tip Number 3
Practice makes perfect! Set up mock interviews with friends or mentors. Focus on articulating your strategic vision for pharmacovigilance and inspection management. The more comfortable you are discussing your ideas, the more confident you'll be during the real deal.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you're genuinely interested in being part of the Kenvue family. Let's get you on board!
We think you need these skills to ace Associate Director PV Strategy and Inspection Management in Reading
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that align with the Associate Director PV Strategy and Inspection Management role. Highlight your relevant experience in pharmacovigilance and compliance, and don’t forget to mention any leadership roles you've had!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to tell us why you're passionate about this role and how your background makes you the perfect fit. Be sure to connect your experiences to Kenvue's mission of everyday care.
Showcase Your Communication Skills:Since this role involves influencing across all levels of the organisation, make sure your written application showcases your excellent communication skills. Use clear, concise language and avoid jargon where possible.
Apply Through Our Website:We encourage you to apply directly through our website for the best chance of being noticed. It’s super easy and ensures your application goes straight to the right people. Plus, we love seeing applications come through our own channels!
How to prepare for a job interview at KENVUE
✨Know Your Stuff
Make sure you brush up on pharmacovigilance regulations and compliance guidelines. Familiarise yourself with Kenvue's iconic brands and their commitment to quality. This will show that you're not just interested in the role, but also in the company’s mission.
✨Prepare for Scenario Questions
Expect questions about how you would handle specific inspection scenarios or compliance challenges. Think of examples from your past experience where you successfully navigated complex regulatory issues. This will demonstrate your problem-solving skills and strategic thinking.
✨Showcase Your Leadership Skills
As an Associate Director, you'll need to lead teams and influence stakeholders. Be ready to discuss your leadership style and provide examples of how you've coached or mentored others in the past. This will highlight your ability to drive a culture of compliance and inspection readiness.
✨Ask Insightful Questions
Prepare thoughtful questions about Kenvue's approach to pharmacovigilance and how they handle inspections. This not only shows your interest but also gives you a chance to assess if the company aligns with your values and career goals.
