Specialist QA Supplier Quality Management

Description

Work Policy
On-site (Halle, Germany)

Core Tech Stack
Electronic QMS platforms (Veeva / TrackWise)

Experience Level
2+ years in Quality Assurance preferred

Job Type
Full-Time

Simtra BioPharma Solutions has spent more than six decades manufacturing sterile injectable medicines for over 60 pharmaceutical clients worldwide, with a particular specialty in cancer treatments. The company runs three sites — two in the US (Indiana and New Jersey) and one in Halle/Westfalen, Germany — employing roughly 2,000 people and offering a full range of injectable delivery formats, from pre-filled syringes to lyophilized vials, plus supporting services like formulation, freeze-drying, and regulatory support. The Halle site specifically produces treatments for cancer and other serious illnesses.

About the Role

This Specialist-level opening (req 2129) owns supplier quality management within a GMP-regulated manufacturing environment, making sure suppliers are properly qualified and continuously monitored.

What You’ll Do

• Maintain and improve the site’s Supplier Quality Management System over time.
• Keep supplier-related records and workflows current in the electronic QMS.
• Handle supplier qualification, approval, and ongoing performance tracking.
• Manage supplier-related deviations, CAPAs, and change requests as they arise.
• Coordinate and support change-control processes tied to suppliers.
• Draft and maintain Supplier Quality Agreements.
• Assist during regulatory inspections and customer audits.
• Contribute input to Annual Product Quality Reviews and other quality reporting.
• Act as a point of contact between internal teams and external supplier partners.

What You’ll Need

• A university degree in a natural science field (pharmacy, chemistry, biology, or similar), or an equivalent qualification such as a German State Pharmacy Examination.
• Roughly 2+ years of Quality Assurance experience is preferred, though not strictly mandatory.
• A solid working knowledge of GMP requirements.
• Prior exposure to supplier qualification work is a plus.
• Familiarity with electronic QMS tools such as Veeva or TrackWise is helpful.
• Some background with CAPA processes, deviation handling, or document management is an advantage.
• Fluent German and English (C1 level or higher in both).
• A communicative, self-directed, solutions-focused working style.

Benefits

Collectively bargained pay including a 13th-month salary bonus and vacation pay, a company pension plan, and supplemental long-term care coverage. Additional perks include a subsidized on-site cafeteria, 30 vacation days plus extra special leave, a 37.5-hour standard work week, a bike-leasing program, discounts through a corporate benefits scheme, convenient transit access with free employee parking, financial help with relocation costs, and free company sports activities such as badminton, football, and fitness classes.