Manager External Supply QA - temporary, 12 month
📍 4416 Bubendorf
Rolle und Verantwortlichkeiten
Vendor Incident Management: Independently handling, investigating, and following up on quality incidents and complaints involving external vendors (including SCAR processing and CAPA control). Change Requests: Processing change notifications and change requests from vendors. Vendor (Re-)Qualification: Actively monitoring, executing, and coordinating vendor qualifications as well as periodic re-qualifications to ensure compliant supply chains. Approving vendors and managing the Trusted Vendor Program, with an ongoing expansion to include equipment suppliers and outsourcing service providers. Interface Coordination & Support: Closely collaborating across departments with Direct Procurement, QC Compliance, Regulatory Affairs, and local QA teams to master current operational challenges.
Team / Beschreibung
Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange.
Qualifikationen und Fähigkeiten
Education: University degree Master or PhD with focus on natural sciences (Chemistry, Process Engineering, Pharmacy, Food Technology or similar field) or an education with equivalent, multi-year professional experience.
Professional Experience: At least 5 years of sound professional experience in quality assurance within the pharmaceutical industry or a pharma CDMO organization.
Expertise & Working Style: A pronounced sense of quality and compliance with a sharp eye for details, sound knowledge of GMP regulations (EU/US/CH), and experience in dealing professionally with vendors.
Language Skills: Fluent English spoken and written (C1 required); German skills are an advantage.
IT & Systems: Routine handling of electronic management and ERP systems (e.g., SAP, MasterControl, and DocuSign) as well as common MS Office applications.