Associate Director, Quality Assurance (Biotechnology, Denmark)

Job summary

An experienced Associate Director of Quality Assurance is sought to oversee GMP compliance for Chemical Intermediates, Biological Intermediates, and Drug Substance manufacturing activities, primarily conducted through external partners. This role is critical for ensuring product quality and patient safety during clinical trials.

Qualifications

• MSc degree in Life Sciences (preferably Cand.pharm.) or equivalent.
• Minimum of 10 years of experience in the pharmaceutical industry with a focus on GMP QA for Clinical Drug Substance and intermediates manufacturing.
• Strong understanding of biologics manufacturing, particularly monoclonal antibodies.
• Fluent in English with a pragmatic, risk-based QA approach.

Responsibilities

• Provide comprehensive QA oversight of CI, BI, and DS manufacturing at CMOs, ensuring GMP compliance and supply continuity.
• Review and release development-stage batches, ensuring adherence to specifications and regulatory requirements.
• Manage deviations, CAPAs, change controls, and risk assessments related to manufacturing activities.
• Lead QA support for regulatory inspections and maintain inspection readiness.
• Conduct audits of CMOs involved in clinical trial manufacturing.
• Contribute to regulatory submissions and maintain quality agreements with CMOs.
• Drive continuous improvement initiatives within the Pharmaceutical Quality System.

Skills

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

Education

• MSc degree in Life Sciences or equivalent.

Tools

• Experience with quality management systems and regulatory compliance tools.