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Senior Manager, Pharmacovigilance Audit Programme Lead
hace 2 meses
**About Us**
At Johnson & Johnson, we are driven by a passion to care for the world, one person at a time. Our corporate philosophy is built on the internationally applicable Credo, which inspires and unites our people around the world.
**Job Summary**
We are seeking a highly skilled and experienced professional to lead our Pharmacovigilance Audit Programme. As a Senior Manager, Pharmacovigilance Audit Programme Lead, you will be responsible for shaping and executing audit strategies to enhance the effectiveness and sustainability of our audit program, while ensuring compliance with global regulatory expectations.
**Key Responsibilities**
- Develop and implement audit strategies to ensure compliance with regulatory requirements and corporate policies.
- Lead the planning, conduct, and reporting of routine and non-routine audits to ensure adherence to internal standards and regulatory requirements.
- Manage and maintain audit risk prioritization tools and provide expert input to risk management strategies.
- Collaborate with business partners to develop and align QA compliance positions.
- Support auditors in the scope definition, planning, conduct, and reporting of audits, providing regulatory and process expertise.
- Provide expert support to auditors and business partners in developing and approving CAPAs.
- Drive resolution of complex CAPAs and foster robust CAPA processes.
- Support regulatory inspection activities and provide training and development strategies for team members.
**Requirements**
- Proven experience in pharmacovigilance and quality assurance.
- Strong knowledge of regulatory requirements and industry standards.
- Excellent leadership and communication skills.
- Ability to work in a fast-paced environment and prioritize multiple tasks.
