Quality Assurance Manager

Metric Bio; Bayern; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading global CDMO is seeking a QA Manager to oversee Quality Assurance at their biologics manufacturing site in Germany. The role involves ensuring GMP compliance, managing QA operations, and collaborating cross-functionally. Candidates should have significant QA experience within the biopharmaceutical sector, strong knowledge of GMP regulations, and excellent leadership skills. This position offers a chance to ensure quality and patient safety at a key facility.

Qualifikationen

• Significant experience in QA roles within biopharmaceutical or CDMO sector.
• Strong knowledge of GMP regulations and quality requirements for biologics.
• Proven track record in batch release, deviation management, CAPAs, and regulatory compliance.

Aufgaben

• Oversee day-to-day QA operations including batch record review and product release.
• Ensure compliance with GMP requirements and regulatory guidelines.
• Collaborate cross-functionally with QC, manufacturing, and regulatory teams.

Kenntnisse

GMP compliance

Leadership

Communication

Cross-functional collaboration

Ausbildung

Advanced degree in a relevant scientific discipline

Jobbeschreibung

Position Overview

A leading global CDMO is seeking a QA Manager to oversee all Quality Assurance activities at their biologics fill/finish manufacturing site in Germany.

This role offers the opportunity to ensure GMP compliance, strengthen the site’s quality systems, and support both clinical and commercial supply while collaborating closely with internal and external stakeholders.

Key Responsibilities

• Oversee day-to-day QA operations, including batch record review, product release, deviation/CAPA management, and change control.
• Ensure compliance with GMP requirements, regulatory guidelines, and internal quality standards across all site functions.
• Act as QA lead for manufacturing operations, providing guidance to production and QC teams to ensure right-first-time execution.
• Support the implementation and continuous improvement of the site’s Quality Management System (QMS).
• Prepare for and actively participate in inspections and audits by regulatory authorities and clients.
• Collaborate cross-functionally with QC, manufacturing, supply chain, and regulatory teams to support both clinical and commercial manufacturing.
• Foster a culture of quality, compliance, and operational excellence within the organization.

Qualifications & Experience

• Advanced degree in a relevant scientific discipline (e.g., Biology, Chemistry, Biochemistry, Pharmaceutical Sciences) preferred.
• Significant experience in QA roles within the biopharmaceutical or CDMO sector.
• Strong knowledge of GMP regulations and quality requirements for biologics fill/finish manufacturing.
• Proven track record in batch release, deviation management, CAPAs, and regulatory compliance.
• Experience working with and improving QMS processes; knowledge of lean or continuous improvement principles a plus.
• 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 play a pivotal role in ensuring quality, compliance, and patient safety at a key fill/finish facility.