Pharmacovigilance Audit Team Lead
3 weeks ago
At Johnson & Johnson, we are committed to delivering innovative solutions that improve human health. As an Associate Director, Pharmacovigilance Audit Team Lead, you will play a critical role in shaping our audit strategy and ensuring compliance with global regulatory expectations.
Key Responsibilities:- Develop and implement risk-based audit plans to drive efficiency and sustainability of the audit program.
- Collaborate with regional partners to ensure QA compliance positions are aligned and effective.
- Lead audit execution to ensure adherence to corporate policies, internal standards, and regulatory requirements.
- Guide auditors in scope definition, planning, conduct, and reporting of audits.
- Identify and resolve regional audit plan challenges and support the strategic direction for the global audit plan.
- Ensure appropriate resources are allocated to support Health Authority inspections.
- May support regulatory inspection activities commensurate with expertise.
- Identify training needs and develop strategies for team to support GxP compliance activities.
- Provide career guidance and ensure development plans are in place for direct reports.
- Directly responsible for supervision and development of direct reports.
- Take an active role in and lead projects and teams in key initiatives across the organization.
- Apply and implement innovative QA audit methodologies.
A minimum of a bachelor's degree is required. A minimum of 8 years of experience in the pharmaceutical/biotech industry is required. Pharmacovigilance Quality and Compliance experience is required. Knowledge of Pharmacovigilance and/or QMS audit required. Audit strategy experience is preferred. Experience with driving culture and change management across a large organization is preferred. Experience with project leadership preferred. Up to 25% travel as per business needs.
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