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 benefits, paid holidays, and learning opportunities.
- Other info: Hybrid work environment with global travel opportunities.
- Why this job: Make a real impact in healthcare by ensuring product safety.
- Qualifications: 8+ years in pharmacovigilance with strong leadership skills required.
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:
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, 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.
Associate Director PV Strategy and Inspection Management in Sonning Common employer: KENVUE
Kenvue is an exceptional employer that prioritises employee well-being and professional growth, offering a competitive benefits package alongside unique opportunities for learning and development. With a vibrant hybrid work culture in Reading, Berkshire, employees are empowered to make impactful contributions while being part of a global team that values every voice and fosters innovation. Join us to be part of a company that not only cares for its customers but also invests in the success and happiness of its employees.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director PV Strategy and Inspection Management in Sonning Common
✨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 a job description just can't.
✨Tip Number 2
Prepare for the interview by diving deep into Kenvue's values and products. Show us that you understand the extraordinary power of everyday care and how your experience aligns with their mission. Tailor your responses to reflect their culture and priorities.
✨Tip Number 3
Practice your STAR technique! When discussing your past experiences, structure your answers around Situation, Task, Action, and Result. This will help you clearly demonstrate your leadership skills and problem-solving abilities, which are crucial for this role.
✨Tip Number 4
Don’t forget to follow up after your interview! A simple thank-you email reiterating your enthusiasm for the position can set you apart from other candidates. Plus, it shows us that you’re genuinely interested in being part of the Kenvue team.
We think you need these skills to ace Associate Director PV Strategy and Inspection Management in Sonning Common
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Associate Director role. Highlight your experience in pharmacovigilance and compliance, and show how your skills align with Kenvue's mission of delivering extraordinary care.
Showcase Your Leadership Skills:Since this role involves strategic direction and team management, don’t forget to mention any leadership experiences you have. We want to see how you've influenced teams and driven compliance in previous roles.
Be Clear and Concise:When writing your application, keep it straightforward. Use clear language and avoid jargon where possible. We appreciate a well-structured application that gets straight to the point while showcasing your qualifications.
Apply Through Our Website:We encourage you to submit your application through our official website. This ensures that your application is reviewed promptly and gives you the best chance to stand out in the process!
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 abilities. Think of examples where you've successfully led teams or projects, especially in complex compliance situations. Be ready to share how you can inspire and guide others at Kenvue.
✨Prepare for Scenario Questions
Expect questions that ask how you'd handle specific inspection scenarios or compliance challenges. Practice articulating your thought process and decision-making strategies, as this will show your problem-solving skills and readiness for the role.
✨Engage with Their Culture
Kenvue values a culture where every voice matters. During the interview, express your enthusiasm for collaboration and innovation. Share how you’ve contributed to a positive workplace culture in the past, and how you plan to do the same at Kenvue.
