Senior Pharmacovigilance Audit Team Lead
3 weeks ago
We are seeking a highly experienced and skilled Pharmacovigilance Audit Team Lead to join our team at Johnson & Johnson. As a key member of our Quality Assurance and Compliance department, you will be responsible for leading and managing audit teams to ensure compliance with regulatory requirements and company policies.
Key Responsibilities- Develop and implement audit strategies to ensure compliance with global regulatory expectations.
- Lead and manage audit teams to conduct audits and inspections, ensuring adherence to company policies and regulatory requirements.
- Provide regulatory and process expertise to auditors, guiding them in the scope definition, planning, conduct, and reporting of audits.
- Identify and resolve audit plan challenges, supporting the strategic direction for the global audit plan.
- Ensure appropriate allocation of auditors to audits within the PV domain.
- Conduct peer review of audit reports.
- Support regulatory inspection activities, ensuring inspection readiness and coordinating with other functions as needed.
- Develop and implement training and development strategies for team members to ensure required skills are available to deliver the audit schedule.
- Provide career guidance and ensure development plans are in place for direct reports.
- Mentor auditors to leverage data analytics tools to analyze relevant data sources and identify trends and insights.
- A minimum of 8 years of experience in the pharmaceutical/biotech industry.
- Pharmacovigilance Quality and Compliance experience is required.
- Knowledge of Pharmacovigilance and/or QMS audit is required.
- Audit strategy experience is preferred.
- Experience with driving culture and change management across a large organization is preferred.
- Experience with project leadership is preferred.
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, please submit your application.
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