Senior GVP QA Manager

The company is seeking a Senior GVP QA Manager in Pratteln to maintain and improve its global Pharmacovigilance System, ensuring compliance with legal obligations for MAH and clinical trial sponsor roles.

The company operates as a Swiss specialty pharmaceutical firm dedicated to creating innovative treatments for patients with rare and high unmet medical needs. This position focuses on upholding and enhancing the global Pharmacovigilance System to guarantee adherence to all legal PV duties for both marketing authorization and clinical trial sponsorship. The role also drives process enhancements and ensures alignment with worldwide regulatory standards.

Responsibilities

• Review and refine the company's Pharmacovigilance System on an ongoing basis.
• Release new PV protocols or update existing ones promptly when necessary.
• Oversee staff training completion for PV requirements, coordinating with line managers.
• Monitor the application of PV standards and procedures across global and local operations.
• Develop the annual PV Audit Plan and adjust it as needed for ad-hoc changes.
• Conduct or assist with internal PV audits and third-party qualification audits.
• Assist with external PV audits and regulatory inspections targeting the company.
• Draft CAPA proposals in response to audit results, inspection outcomes, or safety deviations.
• Approve GVP quality events such as CAPAs, deviations, and quality controls.
• Track CAPA plan execution and closure progress.
• Present audit and inspection findings along with CAPA statuses in the PSMF, contributing to PSMF sections as directed by Drug Safety and Pharmacovigilance.
• Maintain an audit trail for CAPA plans with PV relevance, providing a live overview of their execution and completion status.
• Alert the GCP & GVP QA Lead, Head of DS&PV, and EU/UK Qualified Person for Pharmacovigilance about overdue or at-risk CAPAs.
• Monitor GVP-related KPIs and provide input on GVP quality matters to the company's Quality Council.

Requirements

• Minimum of five years in international Pharmacovigilance, including two years in quality assurance.
• Solid understanding of general quality system standards.
• Prior experience conducting or participating in PV audits and inspections.
• Strong familiarity with European Drug Safety and Pharmacovigilance regulations, with additional knowledge of other regions preferred.
• Fluency in English is required; proficiency in other languages is a plus.

Nice to have

• Proficiency in additional languages beyond English.

About the company

The company emphasizes that its employees are the core of its achievements. Driven by loyalty, courage, and resilience, the team collaborates effectively to navigate change. The workplace is designed to be purposeful, ensuring every contribution counts, fostering professional growth, and enabling the team to make a tangible difference for patients with rare diseases and among themselves.

• Employees are recognized as the primary drivers of company success.
• The team values loyalty, courage, and resilience to thrive through changes.
• The workplace is purposeful, ensuring individual contributions are valued.
• Professional growth is actively fostered within the organization.
• The team works collaboratively to make a real impact for patients and each other.