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Senior Quality Assurance Manager
vor 2 Wochen
Company Overview
We are a leading specialist in the pharmaceutical industry, dedicated to delivering exceptional talent and HR services to our clients. Our team of experts has a deep understanding of the complex regulatory landscape and is well-equipped to handle even the most challenging projects.
Main Responsibilities:
- Provide QA oversight for GCP/PV/GLP activities within the company and at vendor/investigator sites for assigned studies / compounds
- Support and coordinate vendor qualification activities, including audits
- Support continuous improvement of the Quality Management System (QMS) and related processes, including establish and update QMS documents
- Ensure timely and appropriate management of non-conformances related to relevant GCP/PV/GLP deviations, quality issues, investigations, CAPAs, and change control
- Ensure audit results are formally tracked, recorded and reported
- Coordinate and lead internal or external training activities
- Support departmental and cross-functional compliance initiatives as assigned
- Act as QA contact person for vendors/investigator sites for related GCP/PV/GLP studies
- Support and contribute to a risk-based strategy for QA activities (GCP/PV/GLP)
- Support inspection readiness and Vendors conducting GCP, PV, and GLP activities through review audit findings, CAPA generation and review, and training
- Support preparation, conduct and follow up of audits and inspections at client sites and partners as required
- Report critical issues to the Head of Global Quality Management assess their impact and propose risk mitigation as appropriate
- Establish and manage work orders with external QA consultants and CROs
- Maintain a high level of knowledge of current GxP regulations
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required
- Minimum 5 years of experience in the pharmaceutical industry and a minimum of 3 years' experience in QA GCP/GVP
- University or master's degree in pharmacy, chemistry, or equivalent
- Working knowledge of GCP and PV legislation
- Knowledge of product development processes and experience in cross-functional teamwork
- Experience in auditing GCP, PV and GLP, an auditor qualification would be an asset
- Experience in GCP/GVP related Health Authority Inspections (FDA, BfArM, other HA)
- Ability to work both independently and collaboratively, well-organized and structured
- Excellent communication and presentation skills at different levels
- Fluency in English written and spoken is essential, any other language would be beneficial
