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

Job-Room; Lavamünd; Hybrid; EUR 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Flexible working hours

Home office days

Training opportunities

Pension plan

Zusammenfassung

Bachem AG is seeking a Manager External Supply QA (a) for 100% capacity on a temporary 12-month contract. The role focuses on ensuring GMP compliance and quality across the external supply network, working with suppliers, contract manufacturers and cross-functional teams to safeguard quality and reliability of materials and services.

Key responsibilities include incident management, vendor qualification, change management and oversight of the Trusted Vendor Program, with expansion to equipment

Qualifikationen

• University degree at Master or PhD level in natural sciences or equivalent with multi-year experience.
• At least 5 years of professional experience in quality assurance within pharma industry or CDMO.
• Strong knowledge of GMP regulations (EU/US/CH) and vendor-facing experience.
• Fluent English (C1); German language skills are a plus.

Aufgaben

• Vendor Incident Management: investigate and follow up on quality incidents involving external vendors, including SCAR processing and CAPA control.
• Process change notifications and vendor change requests.
• Vendor qualification monitoring, execution and coordination for ongoing supply chain compliance.
• Approve vendors and manage the Trusted Vendor Program, expanding to equipment suppliers and outsourcing providers.
• Coordinate with Direct Procurement, QC Compliance, Regulatory Affairs and local QA teams to address operational challenges.

Kenntnisse

Quality assurance

GMP knowledge

Vendor management

Documentation

Ausbildung

Master or PhD in natural sciences or equivalent

Tools

SAP

MasterControl

DocuSign

Jobbeschreibung

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

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. For further information, see www.bachem.com. 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

The (a) in the job title stands for all.

We welcome applications from all candidates. What matters are your skills and motivation-regardless of age, gender, background, religion, or sexual orientation.

Please note: unsolicited resumes from recruitment agencies will not be considered.