Associate QA Director, Drug Product & CMO Oversight

Zealand Pharma; Søborg; On-site; DKK 900,000 - 1,250,000; Full time

Job summary

Zealand Pharma A/S is seeking an Associate QA Director to provide QA oversight for Drug Product and Combination Product development at external CMOs, with delegated QP responsibilities for clinical and commercial products. The role includes audits, QMS enhancement, and collaboration with partners, with occasional travel and reports to the Head of Manufacturing QA.

The position requires a Masters degree in life science/pharmacy, 10+ years GMP experience, and strong communication skills to lead

Qualifications

• Masters degree in life science, pharmacy, or similar
• At least 10 years of GMP operations experience in the pharmaceutical industry
• Prior QP or QP delegate experience is beneficial
• QA work supporting drug product and combination product development/manufacturing in outsourced set-up
• Strong understanding of late-stage quality assurance for commercial launch
• Solid understanding of GMP requirements and Quality Systems
• Proven ability to drive compliant, timely solutions with a structured, result-oriented approach
• Strong communication skills and willingness to travel

Responsibilities

• Provide QA oversight and compliant guidance for Drug Product and Combination Product development and GMP manufacturing at external CMOs
• Act as QP delegate for both clinical and commercial products
• Collaborate with internal development functions and external CMOs/partners to ensure alignment and issue resolution
• Participate in CMC project teams providing operational QA input to plans, deliverables and risk assessments
• Participate in or lead audits within GMP and GDP
• Maintain and improve the Quality Management System within GMP
• Support preparation for and participation in Health Authority inspections and partner audits

Education

Masters degree in life science, pharmacy, or similar

Job description

Zealand Pharma A/S is seeking an Associate QA Director to provide QA oversight for Drug Product and Combination Product development at external CMOs, with delegated QP responsibilities for clinical and commercial products. The role includes audits, QMS enhancement, and collaboration with partners, with occasional travel and reports to the Head of Manufacturing QA.

The position requires a Masters degree in life science/pharmacy, 10+ years GMP experience, and strong communication skills to lead