Quality R&D Site Lead
The purpose of this role is to manage overall Quality and Compliance activities during the product development & sustainment life cycle end to end processes, support the R&D Categories, compliance support and oversight of research and development pilot plants and labs, and to ensure adherence to market(s) Health Authority regulatory requirements as well as GSK Standards.
This role provides specific GMP Quality Assurance oversight to the local Pilot Plant, Analytical Labs, Stability, and Clinical Supplies areas:
- Drive the implementation of a robust Quality Management System across GMP regulated areas in R&D.
- Manage and lead the Quality / Compliance activities for all assigned new product launches in the Pain and Respiratory categories, as well as provide regional support for other category activities in the EU.
- Be the Quality ambassador and lead the Quality / Compliance activities for all sustainment product remediation and launches for Product Sustainment. Provide quality/compliance support during the product transfer from R&D to internal /external sites
- Manage overall Quality Assurance activities during the product development life cycle processes.
- As Responsible Person for IMPs legally responsible for all products released for human use studies manufactured under his responsibility according to article 5 of local Swiss regulations
- Manage the quality oversight of Pilot, Lab, and Clinical Supply facilities, including compliance responsibilities..
- Manage Heath Authorities and internal audits at local R&D sites and follow up on the appropriateness and completeness of corrective action plans.
- Lead GMP training for R&D and personnel at the site and ensure training practices are in compliance with the current standards.
- Manage a team of 5 direct people
- Advanced degree in Chemistry, Pharmacy Biology, or equivalent scientific degree.
- Minimum 10 years experience in the pharmaceutical industry related to Quality Assurance, Drug Regulatory Affairs, Technical Operations, or Drug Development in a GMP environment.
- Wide-ranging experience preferred.
- QP/RP status (optional)
Knowledge of regulatory requirements, eg. EU, US FDA, EMEA, ICH, MHRA
- Working knowledge of applicable GMP and Regulatory Affairs regulations and guidelines
- Experience working in global and multidisciplinary environments
- Experience with Equipment Qualification/Computer System Validation and Cleaning Validation a must.
- Must be IT systems literate (MS Word, Excel, & Power Point) and be familiar with audit tracking systems (e.g., Trackwise) and regulatory submission management submissions
- Fluent in English
You may apply for this position online by selecting the Apply now button.
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