Manager External Supply QA (a) 100% - (temporary, 12 month)

Bachem; Bubendorf; Hybrid; CHF 140.000 - 200.000; Vollzeit

Benefits dieser Stelle

Flexible hours & home office

Development opportunities

Pension plan with 60% contributions

Swibeco platform discounts

Staff restaurant

Sports on campus

Zusammenfassung

Bachem AG in Bubendorf, Switzerland, seeks an experienced Manager QA (a), 100% temporary for 12 months, to strengthen External Supply Quality Assurance. You will ensure GMP compliance across the external supply network, work with suppliers, contract manufacturers and cross-functional teams, and help maintain quality, safety and reliability of sourced materials.

The role offers a dynamic pharma environment with development opportunities, flexible hours and home-office days.

Qualifikationen

• 5+ years of QA experience in pharma or CDMO.
• Strong GMP knowledge (EU/US/CH) and vendor management.
• Master or PhD in natural sciences or equivalent experience.
• Fluent English (C1); German a plus.
• Experience with SAP, MasterControl or similar systems.

Aufgaben

• Vendor incidents: investigate, manage, and follow up on quality issues (SCAR/CAPA).
• Process change notifications and vendor change requests.
• Vendor qualification: monitor and coordinate qualifications and re-qualifications.
• Approve vendors and manage Trusted Vendor Program expansions.
• Interface coordination with Procurement, QC Compliance, Regulatory Affairs, and local QA teams.

Kenntnisse

GMP knowledge

Vendor management

Quality Assurance

Regulatory compliance

Documentation control

Ausbildung

Master's or PhD in natural sciences

Tools

SAP

MasterControl

DocuSign

Jobbeschreibung

To support our continued organic growth, we are looking for a dedicated and experienced Manager QA (a), 100% (temporary, 12 months) to strengthen our External Supply Quality Assurance team.

In this role, you will be responsible for ensuring compliance with GMP requirements and quality standards across our external supply network. Working closely with suppliers, contract manufacturers, and cross-functional stakeholders, you will play a key role in maintaining the quality, safety, and reliability of externally sourced materials and services. This position offers the opportunity to contribute to a dynamic, fast-growing, and internationally operating pharmaceutical environment.

Your tasks:

• 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.

Your profile:

• 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.

Our offer:

• A dynamic and rapidly growing work environment with internal development opportunities
• Flexible working hours with home office days
• Employee development through numerous internal and external training opportunities
• 60% coverage of pension fund contributions by Bachem AG as well as option for extra-mandatory pension provision with our Pension Plan Plus
• Access to the Swibeco benefits platform with discounts from external partners
• Fresh, healthy and varied food in our staff restaurant
• A wide range of free sports activities on the Bachem Campus

Would you like to drive innovation together with us?

Learn more about the Bachem Group and get inspired by our exciting work environment at our location in Bubendorf!