Pharmacovigilance QA Manager

A global, innovative biopharmaceutical company are searching for a driven PV QA manager to provide vital strategic input at a global level. Within this role you will be responsible for ensuring the highest Quality and Regulatory standards (GMP, GDP, PV) are maintained across all affiliate sites as well as the design, roll-out and execution of PV compliance audit programs.

What will you be doing?

• Serve as the primary contact for internal stakeholders, fostering collaboration and providing expert PV guidance on complex issues.
• Lead key projects and offer strategic advice to drive policy and decision-making.
• Act as the local PV QA Manager for affiliate sites, ensuring the implementation of a standardized PV system aligned with HQ procedures.
• Oversee a risk-based global PV QA audit program, including audits of vendors and affiliates, ensuring adherence to FDA and EMA regulations.
• Ensure audit results are tracked, corrective actions are effective, and vendors are inspection-ready.
• Escalate significant PV compliance issues to senior management and provide necessary QA output for maintaining the PSMF Quality section.
• Collaborate with EU QPPV, ASMs, and Competent Authorities during inspections, representing PV QA.
• Ensure procedures for CAPA, deviation management, and archiving are aligned with company policies; review the effectiveness of these procedures.
• Manage training records and documentation within the Quality System, ensuring compliance and developing local procedures as needed.
• Maintain knowledge of global PV regulations, evaluate changes in country-specific laws, and support impact assessments for new or updated PV regulations.
• Drive accountability for quality and compliance to foster a culture of excellence.

What do you bring to the table?

• Strong working knowledge of global PV regulations (including product complaint and recall management), as well as GMP/GDP requirements.
• Extensive pharmaceutical industry experience (10+ years), specifically within PV, QA and auditing.
• Graduate degree in Pharmacy or related Scientific degree.
• English (fluent), German (desirable), French (desirable).
• Excellent communication and interpersonal skills.