Associate Director PV Strategy and Inspection Management

Associate Director, Pharmacovigilance (PV) Strategy and Inspection Management  

Who we are 

At Kenvue, part of the Johnson & Johnson Family of Companies, we believe there is extraordinary power in everyday care. Built on over a century of heritage and propelled forward by science, our iconic brands—including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® —are category leaders trusted by millions of consumers who use our products to improve their daily lives.  Our employees share a digital-first mindset, an approach to innovation grounded in deep human insights, and a commitment to continually earning a place for our products in consumers’ hearts and homes. 

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. 

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. 

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;-       

KNOWLEDGE, EDUCATION, EXPERIENCE, COMMUNICATION SKILL REQUIREMENTS:  

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 identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.