Associate QA Director - GMP & QP for Drug/Combo

Zealand Pharma; Søborg; Sur place; DKK 1 000 000 - 1 500 000; Plein temps

Résumé du poste

Zealand Pharma seeks an Associate QA Director to provide QA oversight for Drug Product and Combination Product development and GMP manufacturing at external CMOs, with delegated QP responsibilities.

The role emphasizes collaboration with internal development teams and partners, audits, and upkeep of the Quality Management System, with occasional travel. Reporting to the Head of Manufacturing QA, Martin Wallin.

Qualifications

• Master’s degree in life science, pharmacy, or similar.
• At least 10 years of GMP operations experience in the pharmaceutical industry.
• Previous experience with being a QP or QP delegate is beneficial for this role.
• Experience with Quality Assurance work supporting drug product and combination product development and outsourcing.

Responsabilités

• Provide QA oversight for drug product and combination product development activities and GMP manufacturing at CMOs.
• Act as QP delegate for both clinical and commercial products and ensure timely QA releases.
• Collaborate with internal development functions and external CMOs/partners for alignment and issue resolution.
• Participate in or lead internal and external audits within GMP and GDP.
• Maintain and improve the Quality Management System within GMP area (processes, templates, training).

Connaissances

GMP QA

QA oversight

QP responsibilities

Cross-functional collaboration

Strong communication

Willing to travel

Formation

Master’s degree in life science

Description du poste

Zealand Pharma seeks an Associate QA Director to provide QA oversight for Drug Product and Combination Product development and GMP manufacturing at external CMOs, with delegated QP responsibilities.

The role emphasizes collaboration with internal development teams and partners, audits, and upkeep of the Quality Management System, with occasional travel. Reporting to the Head of Manufacturing QA, Martin Wallin.