At a Glance
- Tasks: Lead pharmacovigilance strategy and manage inspection readiness for global compliance.
- Company: Join Kenvue, part of Johnson & Johnson, a leader in everyday care.
- Benefits: Enjoy competitive pay, paid holidays, volunteer time, and summer Fridays.
- Other info: Hybrid work environment with opportunities for global travel and career growth.
- Why this job: Make a real impact on health and safety while working with iconic brands.
- Qualifications: 8+ years in pharmacovigilance, strong leadership, and regulatory knowledge required.
The predicted salary is between 70000 - 90000 £ per year.
Kenvue is currently recruiting for an Associate Director PV Strategy and Inspection Management.
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.
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.
- 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:
- 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 Officer 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 Sonning 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, employees enjoy a hybrid work model that fosters flexibility and collaboration, while also having access to extensive learning and development opportunities to enhance their careers. Join us at Kenvue, where your contributions can make a meaningful impact on millions of lives every day.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director PV Strategy and Inspection Management in Sonning
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those at Kenvue. A friendly chat can open doors and give you insights that a job description just can't.
✨Tip Number 2
Prepare for interviews by researching Kenvue's values and recent projects. Show us how your experience aligns with our mission of delivering extraordinary care through science.
✨Tip Number 3
Practice your pitch! Be ready to explain how your skills in pharmacovigilance and compliance can help Kenvue maintain its high standards during inspections.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed and shows us you’re serious about joining the Kenvue family.
We think you need these skills to ace Associate Director PV Strategy and Inspection Management in Sonning
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Associate Director PV Strategy and Inspection Management role. Highlight your relevant experience in pharmacovigilance and compliance, and don’t forget to showcase your leadership skills!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about Kenvue and how your background aligns with our mission of delivering extraordinary care. Keep it concise but impactful!
Showcase Your Communication Skills:Since this role involves influencing across all levels, make sure to demonstrate your excellent written communication skills in your application. Clear, professional language will go a long way in making a great impression.
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 you’ll be one step closer to joining our amazing team at Kenvue!
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 who can navigate complex compliance topics, so be ready to discuss your experience with inspections and regulatory authorities.
✨Showcase Your Leadership Skills
As an Associate Director, you'll need to demonstrate strong leadership abilities. Prepare examples of how you've led teams through challenging situations, especially in the context of inspection readiness and compliance management.
✨Communicate Effectively
Kenvue values clear communication, especially when dealing with regulatory authorities. Practice articulating your thoughts clearly and concisely, and be prepared to discuss how you've influenced stakeholders at all levels in previous roles.
✨Be Proactive
Kenvue is looking for someone who can take initiative. Think about times when you've identified potential compliance issues before they became problems. Be ready to share these insights during your interview to show that you can drive a culture of inspection preparedness.
