Director of Quality Control

Metric Bio; Bayern; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

A leading global CDMO is seeking a Head of Quality Control to manage QC operations at their biologics fill/finish facility in Germany. This role involves ensuring GMP compliance, leading a high-performing team, and driving operational excellence. The ideal candidate will have significant experience in Quality Control within the biopharmaceutical sector and strong knowledge of QC processes. This position offers a unique opportunity to lead QC operations at a key facility.

Qualifikationen

• Significant experience in Quality Control leadership within the biopharmaceutical or CDMO sector.
• Strong knowledge of GMP regulations and QC requirements for biologics fill/finish manufacturing.
• Proven track record in method validation, stability testing, and batch release for drug substance and drug product.

Aufgaben

• Lead end-to-end Quality Control operations, including method validation and stability testing.
• Ensure full compliance with GMP requirements and internal quality standards.
• Manage and develop cross-functional QC teams, fostering a culture of accountability.
• Collaborate closely with manufacturing, quality assurance, and regulatory teams.
• Oversee laboratory operations ensuring timely and accurate execution of analytical testing.
• Lead QC readiness for inspections and audits from regulatory authorities.

Kenntnisse

Quality Control leadership

GMP compliance

Method validation

Stability testing

Lean management

Cross-functional collaboration

Fluent English

Ausbildung

Advanced degree in a relevant scientific discipline

Jobbeschreibung

Position Overview

A leading global CDMO is seeking a Head of Quality Control to lead all QC operations at their biologics fill/finish manufacturing site in Germany.

This role offers the opportunity to drive operational excellence, ensure GMP compliance, and lead a high-performing QC team supporting both clinical and commercial supply.

Key Responsibilities

• Lead end-to-end Quality Control operations, including method validation, stability testing, and release of drug substance and drug product.
• Ensure full compliance with GMP requirements, regulatory guidelines, and internal quality standards.
• Manage and develop cross-functional QC teams, fostering a culture of accountability, efficiency, and continuous improvement.
• Implement and refine QC processes using lean management principles to enhance efficiency and reduce cycle times.
• Collaborate closely with manufacturing, quality assurance, and regulatory teams to support clinical and commercial production needs.
• Oversee laboratory operations, ensuring timely and accurate execution of analytical testing and reporting.
• Lead QC readiness for inspections and audits from regulatory authorities and clients.

Qualifications & Experience

• Advanced degree in a relevant scientific discipline (e.g., Biology, Chemistry, Biochemistry, Pharmaceutical Sciences) preferred.
• Significant experience in Quality Control leadership within the biopharmaceutical or CDMO sector.
• Strong knowledge of GMP regulations and QC requirements for biologics fill/finish manufacturing.
• Proven track record in method validation, stability testing, and batch release for drug substance and drug product.
• Experience applying lean management principles to improve laboratory and QC operations.
• Excellent leadership, communication, and cross-functional collaboration skills.
• Fluent in English; German language skills are a plus.

This is a rare opportunity to join a global leader in the biologics manufacturing sector and take full ownership of QC operations at a key fill/finish facility.