Associate QA Director: Drug Product & CMO Quality Oversight

Zealand Pharma; Søborg; On-site; DKK 1,200,000 - 1,700,000; Full time

Job summary

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. You will collaborate with internal development functions and external CMOs, drive timely quality decisions, lead internal and external audits, and continuously improve the GMP quality system.

The role reports to the Head of Manufacturing QA and requires a Master\'s degree with 10+ years in GMP in

Qualifications

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

Responsibilities

• Provide QA oversight for drug product and combination product development and GMP manufacturing at CMOs.
• Act as QP delegate for clinical and commercial products.
• Ensure timely QA releases of batches from CMOs and provide timely quality guidance.
• Collaborate with internal development functions and external CMOs and partners to ensure alignment and issue resolution.
• Participate in CMC project teams, providing operational QA input to plans and risk assessments.
• Participate in or lead internal and external audits within GMP and GDP.
• Maintain and improve the Quality Management System within GMP.
• Support preparation for Health Authority inspections and partner audits, including readiness activities.

Skills

QA leadership

GMP knowledge

Strong communication

Education

Master's degree in life science or pharmacy

Job description

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. You will collaborate with internal development functions and external CMOs, drive timely quality decisions, lead internal and external audits, and continuously improve the GMP quality system.

The role reports to the Head of Manufacturing QA and requires a Master\'s degree with 10+ years in GMP in