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Manager QA PV Auditor

J&J Family of Companies

Manager QA PV Auditor

Salary Not Specified

J&J Family of Companies, Kilsby, Northamptonshire

  • Full time
  • Permanent
  • Onsite working

Posted 2 weeks ago, 2 May | Get your application in now before you miss out!

Closing date: Closing date not specified

job Ref: c02508a86b334299be4e28257d5f76bf

Full Job Description

  • Actively shares business area and regulatory knowledge/expertise and may act as a primary contact for internal and/or external stakeholders.

  • Conducts Peer review of audit reports, as required

  • Independently provides consultation and advice to Business Partners on quality and compliance processes/procedures.

  • Interprets and applies regulations/policies to unique and/or complex issues, when required., Auditing

  • Independently leads the planning, conduct, reporting of RnD QA routine and non-routine audits of processes, internal organizations like Operating Companies, External Partners (e.g. distributors, External Service Providers, Marketing Partners) in Pharmacovigilance area to assure adherence to corporate policies, internal standards/requirements, compliance with applicable regulatory requirements and contractual obligations.

  • Non-routine audits include Due Diligence, for cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope. Manages complex or business critical audits/issues in a supporting or leading role.

  • Supports other auditors in planning, conduct and reporting of audits.

  • Ensures the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities.

  • Supports the CAPA process following the audit as needed.

  • Encourages and supports others to properly manage and document the risk-based approach in the audit planning and conduct


    • Inspection Support
  • May participate in regulatory inspections in a leadership role (e.g. host, backroom lead)


    • Training & Development
  • Identifies training needs. Supports Development and provides training. Independently advises and coaches other auditors.

  • Involved with the review and approval of curriculum as applicable

  • Completes training requirements in a timely manner to ensure inspection readiness at all times.


    • People Management
  • Able to supervise junior auditors/contractors

  • Deputises for Team Lead, as required.


    • Project Management
  • Leads initiatives and actively participates in key projects across the organization or company. Interacts with key stakeholders and can influence and effectively drive projects to completion.

    Minimum bachelor's or equivalent University degree required; Focused degree in a life, natural, or computer science is preferred, A minimum of 5-10 years of relevant work experience is required with at least 2 years of pharmacovigilance audit experience.

  • Strong project management experience

  • Strong verbal and written skills, including presentation skills.

  • Strong teamwork and analytical skills


    • Preferred:
  • Experience in leading complex pharmacovigilance audit types e.g., system audits


    • Other:
  • Must be fluent in English.

  • This position requires 10%-30% domestic and international travel.

    At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.


    • Diversity & Inclusion are crucial to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions! Are you ready to join our team? Then read further!