Associate Director, Quality Assurance (Pharmaceutical, Denmark)

Job summary

This role involves providing strategic and operational Quality Assurance oversight for development-stage manufacturing activities supporting clinical trials, primarily through external manufacturing partners. The position is crucial for ensuring product quality, patient safety, and reliable supply within a fully outsourced development manufacturing network.

Qualifications

• MSc degree (preferably Cand.pharm.) or equivalent in Life Sciences.
• Minimum of 10 years of experience in the pharmaceutical industry with extensive GMP QA experience in Clinical Drug Product and IMP.
• Experience as a QP delegate for DP, IMP, with knowledge of post-trial access and Access Programs being advantageous.
• Strong understanding of Drug Product biologics manufacturing, particularly monoclonal antibodies.
• Proficient in English with a pragmatic, risk-based QA approach.

Responsibilities

• Oversee end-to-end QA processes for DP and IMP manufacturing activities, ensuring GMP compliance and supply continuity.
• Act as a QP delegate for DP and IMP.
• Maintain independent decision-making for batch disposition based on risk assessments.
• Conduct audits of internal processes and CMOs, ensuring adherence to quality standards.
• Review and approve batch documentation and manufacturing data prior to release.
• Mentor and support junior colleagues, fostering a collaborative work environment.
• Manage deviations, CAPAs, change controls, and risk assessments related to manufacturing activities.
• Lead QA support for regulatory inspections at CMOs.

Skills

• Strong collaboration and communication skills.
• Ability to thrive in a dynamic and changing environment.
• Positive mindset and supportive team player.

Education

• MSc degree in Life Sciences or equivalent.

Tools

• Familiarity with Pharmaceutical Quality Systems and regulatory compliance frameworks.