Associate QA Director, Manufacturing QA

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

Does it excite you to work with GMP Quality Assurance for Drug Product and Combination Products in an outsourced development set-up, and do you have experience with QA oversight of CMOs, QP responsibilities, and cross-functional CMC collaboration? If this sounds like you, and you are ready to take on a broad area of responsibilities, then you could be our new colleague.

Your new position

As our Associate QA Director, you will provide QA oversight and compliant quality guidance for Drug Product and Combination Product development and GMP manufacturing performed at external CMOs and in close collaboration with partners. You will help ensure robust GMP execution and timely quality decisions. In addition, the role contains delegated Qualified Person (QP) responsibilities for both clinical and commercial products, in accordance with applicable GMP legislation. The role also involves occasional travel to support effective oversight and collaboration with external sites. You will join Manufacturing QA in an outsourced business model where strong collaboration and clear quality judgment are key.

We Offer Exciting Responsibilities

• Ensure timely QA Releases of batches from CMOs
• Act as QP delegate for both clinical and commercial products
• Provide QA oversight and timely quality guidance for drug product and combination product development activities and GMP manufacturing at CMOs
• Collaborate closely with internal development functions and external CMOs and partners to ensure alignment, compliance, and effective issue resolution
• Participate in CMC project teams, providing operational QA input to plans, deliverables, and risk assessments
• Participate in or lead internal and external audits within GMP and GDP
• Maintain and continuously improve the Quality Management System within the GMP area (processes, templates, training, and ways of working)
• Support preparation for and participation in Health Authority inspections and partner audits, including readiness activities and documentation review

Your profile

• 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 Quality Assurance work supporting drug product and combination product development and manufacturing in an outsourced set-up
• Good understanding with late-stage quality assurance for commercial launch
• Solid understanding of GMP requirements and Quality Systems within pharmaceutical development and manufacturing.
• Proven ability to drive compliant, timely solutions with a structured, result-oriented, and approachable way of working
• Strong communication skills (written and verbal), including interaction with external suppliers and partners; willingness to travel as required

Your new team

You will join Manufacturing QA, which provides QA support and oversight across manufacturing-related activities in an outsourced business model. The team works closely with internal development stakeholders as well as external CMOs and partners to ensure compliant execution, robust quality decisions, and readiness for inspections and partner interactions. The position reports to Martin Wallin, Head of Manufacturing QA.

Let's bond and be bold

We have a unique culture, characterized by excellent teamwork and strong engagement across the organization. And we want you to help us strengthen this culture.

Making bonds is at the core of everything we do. From discovering and developing the best new peptide drugs for patients, to engaging with our partners or connecting with each other. We bond through curiosity and playfulness as a team, allowing ourselves to challenge common thinking and drive future innovation. Join us and let's bond and be bold.

For further information, please contact Head of Manufacturing QA, Martin Wallin, [e-mail].

We are committed to an inclusive recruitment process and welcome applications from all job applicants.

About Zealand Pharma A/S

Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on advancing medicines for obesity and metabolic health. Combining more than 25 years of peptide R&D expertise with a proprietary data platform that leverages advanced data-driven and AI/ML approaches, Zealand Pharma aims to lead a new era in obesity and metabolic health. To date, more than ten Zealand Pharma-invented drug candidates have entered clinical development, of which two products have reached the market and three candidates are in late-stage development. The Company has collaborations with global pharmaceutical and biotechnology partners for research, development, and commercialization. Founded in 1998, Zealand Pharma is headquartered in Copenhagen, Denmark, with a U.S. presence in Boston, Massachusetts. Learn more at www.zealandpharma.com.