Senior Manager, Quality Country GxP Compliance (Alpine) & Responsible Person (Switzerland)
Reports to: Associate Director, CENE Regulatory Affairs
Job Summary
The Senior Manager, Quality Country GxP Compliance (Alpine) and Responsible Person (Switzerland) is responsible for ensuring compliance with Swiss GMP/GDP regulations and maintaining the quality management system (QMS) for all GMP/GDP activities in Switzerland.
Key Responsibilities
* Direct technical supervision of the company's operations to ensure safe trading of medicinal products in Switzerland.
* Operating the Swiss Establishment License for import with market release and ensuring traceability of medicinal products traded within Switzerland.
* Ensuring medicinal products are supplied in accordance with GMP and GDP rules in Switzerland.
* Decision on the release or non-release of a batch for the Swiss market, independently of company management.
* Archiving general and batch-specific documents concerning manufacture and testing of medicinal products released onto the Swiss market.
Quality Management System (QMS) Management
* Implementing, monitoring, and maintaining the local QMS for all GMP/GDP activities in Switzerland.
* Setting-up and updating quality agreements (QAGs) for delegated or subcontracted activities.
* Maintaining the Swiss Site Master File.
Product Quality Complaints, Defects, and Recalls
* Monitoring local complaints from the Swiss market and notifying the Global Complaint Handling Unit of all local complaints.
* Evaluating classification of quality defects and ensuring they are reported to Swissmedic according to Swiss requirements.
* Contacting Corporate QA regarding potential product recall issues in Switzerland.
Other Responsibilities
* Partnering with leads and colleagues to ensure roll-out and ongoing compliance to Alexion's global quality and compliance systems.
* Providing internal auditing resource to assess cluster compliance on a regular basis.
* Managing review and implementation of quality improvement/remediation plans for identified affiliates through corporate audits.
Qualifications
The Responsible Person must demonstrate appropriate education, knowledge, experience, trustworthiness, and independence, as per Swiss MPLO (Art. 17 and 18). Required qualifications include higher education in natural sciences, one to four years of GMP and GDP experience, and technical knowledge of processes for which the RP will be responsible.