Project Manager (QA Operations)

An exciting opportunity has arisen for an experienced Project Manager (QA Operations) to support a significant quality transformation programme at a leading pharmaceutical manufacturing site in Pfaffenhofen. This project is part of a wider initiative to enhance operational quality standards and ensure compliance with global GMP and GDP requirements.

This contract engagement will see the successful consultant play a key role in overhauling critical quality systems and driving best practices across warehousing and QA operations. It's an ideal opportunity for a seasoned QA professional to make a meaningful impact in a dynamic environment committed to strengthening its quality framework.

Your role as Project Manager (QA Operations)

• Oversee the restructuring of established quality management processes, including Product Quality Reviews (PQR), Change Control, Deviation & CAPA handling, and Supplier Qualification.

• Lead the strategic separation of GDP warehousing from GMP warehousing processes to ensure clear compliance boundaries and streamlined operations.

• Develop and implement new quality processes for GMP warehousing, aligning with international regulatory expectations.

• Build and formalise the local QA Operations training framework to support consistent quality standards across the site.

• Provide expert input on quality topics throughout the Re-Org project lifecycle, acting as a trusted advisor on compliance and risk.

• Support preparation for internal and external audits, ensuring that quality systems withstand regulatory scrutiny.

Experience and qualifications for the Project Manager (QA Operations) role

• Proven track record in designing and enhancing QA processes within GMP and GDP regulated environments.

• Degree-qualified in Pharmacy or a similar scientific discipline, with solid grounding in pharmaceutical quality requirements.

• Hands-on experience establishing new QA structures in large-scale pharmaceutical operations.

• Well-versed in managing and supporting audits and regulatory inspections, with confidence in front of auditors.

• Fluent in both German and English, with excellent communication skills for cross-functional collaboration.

• Open to a flexible working arrangement, with up to 50% remote possible by agreement.

For immediate consideration, or to explore similar contract opportunities in pharmaceutical quality, please apply now or reach out directly.