External Supply QA Manager GMP Compliance & Vendor Quality

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

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