Manager, PV Quality Assurance
A global Pharma is looking for an experience Quality Assurance Manager PV to support Quality oversight.
- Manager, PV QA supports all the GVP QA responsibilities as listed below. Different members of the team will have specific focus areas:
- Execute on global core auditing processes for licensing partners, external vendors, internal audits, affiliates, and other applicable service providers in a post-marketing environment.
- Support cross GxP QA activities requiring PV expertise, as requested.
- Determine, evaluate, and investigate Quality Events. Determine adequacy of root cause analyses and CAPAs. Applies risk-based thinking in determining required actions.
- Effectively communicate and escalate quality concerns and critical matters to management.
- Provide QA Audit, CAPA and Supplier data for the PV System Master File (PSMF). Develop and maintain efficient processes to ensure comprehensive and accurate data.
- Develop and maintain processes and tools to support quality audit execution and outcomes.
- Support PV / post-marketing surveillance inspection readiness and inspection management activities.
- Support Quality oversight activities for PV and PV related vendors. This includes vendor notification, qualification assessments, Quality Agreements, KQIs and audits.
- Develop and report PV QA metrics and dashboards to support Quality oversight.
Skills and Requirements
- Educated to university degree (preferably life sciences) or equivalent qualification or experience
- Experience in the Pharmaceutical industry in a quality or compliance function, GxP auditing, pharmacovigilance, regulatory affairs, and/or clinical research.
- Audit skills, and experience of conducting GVP audits is preferred.
- Knowledge of and working experience with international GVP regulations, FDA PV requirements, Health Authority guidances and ICH.
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