Associate QA Director, Drug Product & CMO Compliance

Zealand Pharma A/S; Gladsaxe Kommune; On-site; DKK 1,200,000 - 1,800,000; Full time

Job summary

Zealand Pharma A/S seeks an Associate QA Director to provide QA oversight and compliant guidance for Drug Product and Combination Product development and GMP manufacturing at CMOs and with partners.

The role includes delegated QP responsibilities for clinical and commercial products, audits, and ongoing QA system improvements to support inspections and regulatory readiness. Travel may be required. Reporting to Head of Manufacturing QA, you will lead collaboration across external sites.

Qualifications

• Master's degree in life science, pharmacy, or similar.
• At least 10 years of GMP operations experience in the pharmaceutical industry.
• 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 manufacturing in an outsourced set-up.
• Strong understanding of GMP requirements and Quality Systems in pharmaceutical development and manufacturing.

Responsibilities

• Provide QA oversight and compliant guidance for drug product and DP/CP development and GMP manufacturing at CMOs.
• Ensure timely QA releases of batches from CMOs.
• Act as QP delegate for clinical and commercial products.
• Collaborate with internal and external partners to ensure alignment and issue resolution.
• Participate in CMC project teams, providing QA input to plans and risk assessments.
• Lead or participate in internal/external GMP and GDP audits.
• Maintain and improve the Quality Management System within GMP scope.
• Support Health Authority inspections and partner audits, including documentation review.

Skills

QA oversight

QP delegate

GMP operations

Quality Systems

Stakeholder comms

Education

Master's degree in life science or pharmacy

Job description

Zealand Pharma A/S seeks an Associate QA Director to provide QA oversight and compliant guidance for Drug Product and Combination Product development and GMP manufacturing at CMOs and with partners.

The role includes delegated QP responsibilities for clinical and commercial products, audits, and ongoing QA system improvements to support inspections and regulatory readiness. Travel may be required. Reporting to Head of Manufacturing QA, you will lead collaboration across external sites.