Global Senior PV QA Manager
Location: Basel, Switzerland
Employment: Full‑time, Permanent
The Global Senior Pharmacovigilance QA Manager plays a key strategic role in ensuring the robustness, compliance, and continuous improvement of the global Pharmacovigilance (PV) Quality System. The position leads global PV audit activities, supports inspection readiness, and ensures harmonized PV processes across affiliates in alignment with international regulatory requirements.
Key Responsibilities
- Lead, plan, and execute global risk‑based PV QA audit programs (internal, external, vendor, affiliate).
- Ensure consistent implementation of PV Quality Systems across global affiliate sites.
- Act as PV QA liaison for affiliates, providing expert guidance, oversight, and strategic support.
- Manage audit reporting, tracking, trending, and CAPA effectiveness verification.
- Support and lead interactions with global Health Authorities during PV inspections; ensure inspection readiness.
- Monitor PV compliance issues and escalate significant risks to senior leadership.
- Provide timely Quality input for PSMF (Quality section and audit annexes).
- Ensure vendors conducting PV activities meet compliance standards through ongoing oversight, metrics, audit outcomes, and CAPA follow‑up.
- Oversee local quality documentation, training compliance, and GxP‑related processes (deviations, change controls, CAPAs).
- Maintain strong knowledge of global PV regulations (EU, US, Canada, ICH) and assess impact of regulatory changes.
- Facilitate PV Quality knowledge exchange across affiliates and promote a culture of quality and compliance.
- (Advantage) Support commercial affiliate QA/GDP activities, including supply chain QA oversight.
Qualifications & Experience
- Master's degree in Pharmacy or relevant life sciences.
- Extensive background in Pharmacovigilance and Quality Assurance (approx. 10+ years).
- Proven experience conducting PV audits across HQ, affiliates, distributors, or partners.
- Strong understanding of global PV laws and guidelines (EU GVP, FDA, Health Canada, ICH).
- Prior experience supporting or coordinating PV inspections (FDA, EMA, MHRA, ANSM, BfArM, Swissmedic).
- Skilled in training, risk management, problem‑solving, and cross‑functional collaboration.
- Excellent communication skills with the ability to influence and manage stakeholders globally.
- Fluent English; German or French is a plus.
- Proficient in Microsoft Office.
- (Advantage) Experience in GDP, warehousing, distribution, or Supply Chain QA.
Ready to make an impact?
Apply now with your CV.
Please note : Only candidates with the right to work in Switzerland (EU citizens or holders of a valid Swiss work permit) can be considered.
Only selected candidates will be contacted.
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