Senior Manager, Quality Assurance (PVQA)

Location: Maidenhead

Work Mode: Hybrid

Requisition ID: 2751

About the Role

Alnylam is looking for a Senior Manager, Quality Assurance (PVQA) to join our team in Maidenhead. This role is critical in ensuring the highest standards of pharmacovigilance quality and compliance across our global operations.

Key Responsibilities

• Lead and manage pharmacovigilance quality assurance audits, including internal process audits and external vendor audits.
• Develop and maintain the PV Quality Management System (QMS) to ensure compliance with global regulations (GVP).
• Provide expert guidance on PV compliance issues and support regulatory inspections.
• Manage CAPA (Corrective and Preventive Actions) processes resulting from audits and inspections.
• Collaborate with cross-functional teams to drive continuous improvement in PV processes.

Requirements

• Extensive experience in Pharmacovigilance Quality Assurance within the pharmaceutical or biotech industry.
• In-depth knowledge of global GVP regulations and standards.
• Proven track record of managing complex audit programmes and regulatory inspections.
• Strong leadership skills with the ability to influence stakeholders at all levels.
• Excellent analytical and problem-solving capabilities.

Benefits

• Competitive salary and benefits package.
• Hybrid working environment.
• Opportunities for professional growth and development within a leading biotech company.

Alnylam is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, colour, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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