Pharmacovigilance Auditor

2 months ago

High Wycombe, Buckinghamshire, United Kingdom Kenvue Full time

About Kenvue

Kenvue is a leading consumer goods company that has been at the forefront of science for over a century. We are a house of iconic brands, including NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSON'S, and BAND-AID.

Job Summary

We are seeking a highly skilled Pharmacovigilance Auditor - Lead Specialist to join our team. As a key member of our BioResearch Quality and Compliance team, you will be responsible for leading the planning, conduct, and reporting of audits to ensure compliance with regulatory requirements and corporate policies.

Key Responsibilities

  1. Lead Audits
  • Plan, conduct, and report on routine and non-routine audits of activities, data, internal facilities, and processes in Good Vigilance Practices (GVP) to verify adherence to corporate policies, internal standards/requirements, and compliance with applicable regulatory requirements.
Conduct Specialized Audits
  • Conduct non-routine audits, including Due Diligence, for cause audits, cross-functional, system/service provider audits as defined by the scope.
Support Other Auditors
  • Support other auditors in planning, conduct, and reporting of audits.
Ensure Audit Quality
  • Ensure the relevant standard procedures, diagnostic tools, and audit plans and scope are fully understood and applied in audit activities.
Participate in Regulatory Inspections
  • Participate in regulatory inspections in core and supporting roles.
Contribute to PV Quality & Compliance Strategy
  • Contribute to the overall PV Quality & Compliance strategy.
Assist in Training and Coaching
  • Assist in preparation and delivery of training materials.
  • Advise and contribute to coaching, including audit outcomes and Corrective and Preventive actions.
Meet Priorities and Timelines
  • Meet priorities, checkpoints, and timelines for all aspects of work and projects to achieve adequate progress.
Provide Expertise and Knowledge
  • Provide expertise and knowledge to others in BioResearch Quality and Compliance, Business Partners, and the core business sector on quality and compliance processes/procedures.
Interpret and Apply Regulations
  • Interpret and apply regulations/policies to issues of moderate complexity, when required.

Requirements

  1. Education
  • A minimum of a Bachelor's Degree is required.
Experience
  • A minimum of 5 years of experience in pharmacovigilance, quality, and/or compliance is required.
Knowledge and Skills
  • Comprehensive knowledge of the drug development process, applicable regulations (GxP), R&D practices, and scientific and quality terminology is required.
  • 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 proficient in Microsoft Office applications and possess a Quality mindset.

What We Offer

  1. Competitive Compensation and Benefits
  • Paid Company Holidays, Paid Vacation, Volunteer Time & More
Learning and Development Opportunities
  • Learning & Development Opportunities.

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