Pharmacovigilance Auditor - Lead Specialist

The Bioresearch Quality & Compliance (Q&C) Pharmacovigilance Auditor Lead Specialist independently leads the planning, conduct and reporting of routine/non-routine Good Pharmacovigilance Practice (GVP) audits, including internal processes, partners and service providers. These audits provide an independent quality assessment to verify compliance with appropriate regulations, SOPs, processes, etc. as they pertain to company-sponsored R&D and post-marketing pharmacovigilance activities, within the regions (Americas, Europe Middle East & Africa (EMEA), Asia Pacific). Also contributes to or may lead other compliance and quality activities, as assigned.

• Independently leads the planning, conduct and reporting of BRQC routine and non-routine audits of activities, data, internal facilities and processes in GVP to verify adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements
• Non-routine audits include Due Diligence, for cause audits, cross-functional, system/service provider audits as defined by the scope
• May support other auditors in planning, conduct and reporting of audits
• Ensures the relevant standard procedures, diagnostic tools, and audit plans and scope are fully understood and applied in audit activities
• Participates in regulatory inspections in core and supporting roles
• Contributes to the overall PV Quality & Compliance strategy
• Assists in preparation and delivery of training materials
• Advises and contributes to coaching, including audit outcomes and Corrective and Preventive actions
• Completes training requirements in a timely manner to ensure inspection readiness at all times
• Takes an active role in projects as assigned by supervisor and interacts with key stakeholders as appropriate
• Meets priorities, checkpoints and timelines for all aspects of work and projects to achieve adequate progress
• Provides expertise and knowledge to others in BRQC, Business Partners and the core business sector on quality and compliance processes/procedures
• Interprets and applies regulations/ policies to issues of moderate complexity, when required
  
  What we are looking for
• A minimum of a Bachelors Degree is required
• A minimum of 5 years of experience in pharmacovigilance, quality and/or compliance is required
• Comprehensive knowledge of the drug development process, applicable regulations (GxP), R&D practices, and scientific and quality terminology is required
• Expertise in GVP regulations and one or more specific compliance disciplines (GLP, GCP) preferred
• Knowledge of procedural and records management requirements in a regulated industry preferred
• Prior pharmaceutical, consumer personal products and quality/compliance related experience preferred
• Must have excellent communication skills and be fluent in written and spoken English
• Must be a team player, organized and detail oriented, and possess sound problem solving and good negotiating skills
• Must be proficient in Microsoft Office applications and possess a Quality mindset
  
  At Kenvue, we realise the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, were the house of iconic brands - including NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSONS and BAND-AID that you already know and love. Science is our passion; care is our talent. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of 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 futureand yours.
  
  Competitive Benefit Package
• Paid Company Holidays, Paid Vacation, Volunteer Time & 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, 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.