Manager Quality Control (80-100%)

Ophtapharm AG seeks a Manager Quality Control to lead the QC department at its sterile pharmaceutical manufacturing site in Hettlingen, ensuring GMP compliance and operational excellence.

The company is looking for a leader to oversee the Quality Control department, including Analytical Chemistry and collaboration with Microbiology and In-Process Control. The role focuses on ensuring reliable, compliant testing of materials and products while driving continuous improvement, digitalization, and inspection readiness within a highly regulated GMP environment.

Responsibilities

• Direct and develop the QC team, fostering collaboration with Microbiology and In-Process Control units.
• Oversee GMP-compliant testing and release processes for raw materials, in-process samples, and finished goods.
• Enhance laboratory performance through continuous improvement, digitalization efforts, and strict data integrity standards.
• Lead root cause investigations, implement CAPAs, and maintain readiness for regulatory inspections.
• Manage, coach, and develop the professional growth of QC staff.

Requirements

• University degree in Chemistry, Pharmacy, or a related Life Sciences field.
• Proven experience in pharmaceutical Quality Control, including leadership roles within GMP-regulated manufacturing.
• Strong analytical skills, particularly with HPLC and conducting laboratory investigations.
• Deep understanding of GMP regulations and experience supporting regulatory inspections and audits.
• Fluent proficiency in both German and English.

What the company offers

• A prominent leadership position overseeing Quality Control at an FDA/EU-GMP certified facility.
• The chance to influence laboratory performance, process optimization, and continuous improvement projects.
• Direct engagement with health authorities, customer auditors, and senior management.
• A multifaceted role blending people management, regulatory compliance, and operational excellence.
• A lean organizational structure characterized by short communication paths, rapid decision-making, and visible impact.

About the company

Ophtapharm AG is a certified manufacturer specializing in ophthalmic pharmaceutical products. The company produces high-quality eye drops, ointments, and gels aseptically, filling and packaging them for distribution across international markets.

• Operates as an FDA/EU-GMP certified manufacturer in the pharmaceutical sector.
• Focuses on aseptic production, filling, and packaging of ophthalmic products for global markets.