At a Glance
- Tasks: Lead pharmacovigilance strategy and ensure compliance during inspections.
- Company: Join Kenvue, a part of Johnson & Johnson, known for iconic brands.
- Benefits: Enjoy competitive pay, paid holidays, volunteer time, and summer Fridays.
- Other info: Hybrid work model with global travel opportunities.
- Why this job: Make a real impact in healthcare while working with a passionate team.
- Qualifications: 8+ years in pharmacovigilance with strong leadership and communication skills.
The predicted salary is between 80000 - 100000 £ 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:
Describe the primary working relationships (internal & external) and primary interfaces along with the frequency and purpose/nature. 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
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 Newtown employer: KENVUE
Kenvue is an exceptional employer that prioritises employee well-being and professional growth, offering a competitive benefits package alongside a vibrant work culture where every voice is valued. Located in Reading, Berkshire, our hybrid work model fosters flexibility while empowering you to make a meaningful impact on global health through our iconic brands. Join us to be part of a passionate team dedicated to innovation and care, with ample opportunities for learning and development.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director PV Strategy and Inspection Management in Newtown
✨Tip Number 1
Network like a pro! Reach out to people in your industry, especially those who work at Kenvue or similar companies. A friendly chat can open doors and give you insider info that could help you stand out.
✨Tip Number 2
Prepare for interviews by researching Kenvue's values and recent projects. Show them you’re not just another candidate; you’re genuinely interested in their mission of everyday care and innovation.
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience aligns with the role of Associate Director PV Strategy and Inspection Management. Highlight your leadership skills and compliance expertise to make a lasting impression.
✨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 serious about joining the Kenvue team.
We think you need these skills to ace Associate Director PV Strategy and Inspection Management in Newtown
Some tips for your application 🫡
Read the Job Description Carefully:Before you start your application, make sure to read through the job description thoroughly. It’s packed with important details about what Kenvue is looking for, and it’ll help you tailor your application to match their needs.
Showcase Your Relevant Experience:When writing your application, highlight your experience in pharmacovigilance and quality settings. Use specific examples that demonstrate your leadership skills and how you've tackled complex compliance topics in the past.
Be Clear and Concise:Keep your application clear and to the point. Avoid jargon and overly complex language. Kenvue values effective communication, so make sure your writing reflects that by being straightforward and easy to understand.
Apply Through Our Website:Don’t forget to submit your application through our website! It’s the best way to ensure it gets seen by the right people. Plus, you’ll find all the resources you need to make your application stand out.
How to prepare for a job interview at KENVUE
✨Know Your Stuff
Make sure you brush up on pharmacovigilance regulations and compliance guidelines. Kenvue is looking for someone with a solid understanding of these areas, so be prepared to discuss your experience and how it relates to their needs.
✨Showcase Your Leadership Skills
As an Associate Director, you'll need to demonstrate your leadership capabilities. Think of examples where you've successfully led teams or projects, especially in complex compliance situations. Be ready to share these stories during the interview.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific inspection scenarios or compliance challenges. Practise articulating your thought process and decision-making strategies, as this will show your ability to navigate complex issues effectively.
✨Engage with Insightful Questions
At the end of the interview, have some thoughtful questions ready about Kenvue's approach to inspection readiness and compliance. This not only shows your interest but also gives you a chance to assess if the company aligns with your values and career goals.
