Senior Manager PV Quality Assurance
A fantastic opportunity has arisen for a Senior PV Quality Assurance Manager. You will be provide Quality Oversight, including clinical safety and implementation of global PV regulations. You will also be given the flexibility to work from home during the week.
- Serve as a strong partner with functional areas in the enhancement of the global pharmacovigilance system, including ensuring compliance with GVP regulations. This includes review of procedural documents.
- Support GxP QA activities requiring PV expertise..
- Execute on global core auditing processes for licensing partners, external vendors, internal process audits, affiliates, and other applicable service providers in a post-marketing environment.
- Determine, evaluate and investigate Quality Events. Confirm adequacy of root cause analyses and CAPAs. Applies risk-based thinking in determining required actions.
- Effectively communicate and escalate critical matters to management.
- Provide QA Audit, CAPA and Supplier data for the PV System Master File (PSMF). Develop and maintain efficient process 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.
- Provide Quality oversight of 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.
- Develop and maintain PV QA Training Plan; conduct PV training sessions for QA and EAs.
Skills and Responsibilities
- Educated to university degree (preferably life sciences) or equivalent qualification or experience
- Extensive experience in the Pharmaceutical industry in a quality or compliance function..
- Audit skills, and experience of conducting GVP audits is preferred.
- Understanding of and working experience with international GVP regulations, FDA PV requirements, Health Authority guidances and ICH.
- Experience supporting Health Agency inspections.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.