Associate Director, Quality Assurance (Pharmaceutical, Denmark)

Job summary

An experienced Associate Director of Quality Assurance is sought to oversee Quality Assurance for Chemical Intermediates, Biological Intermediates, and Drug Substance activities supporting commercial products manufactured through external partners. This role is crucial for ensuring product quality, patient safety, and supply reliability in a fully outsourced manufacturing environment.

Responsibilities

• Provide comprehensive QA oversight of commercial manufacturing activities at Contract Manufacturing Organizations (CMOs) to ensure GMP compliance and supply continuity.
• Certify and release batches according to GMP legislation and approved Marketing Authorization requirements.
• Maintain independent decision-making for batch disposition based on documented risk assessments.
• Act as the Qualified Person (QP) representative during regulatory inspections as needed.
• Review and approve batch documentation and manufacturing data in line with the Pharmaceutical Quality System.
• Establish quality agreements with CMOs, ensuring accountability and clear escalation pathways.
• Oversee deviations, CAPAs, change controls, and risk assessments for manufacturing processes.
• Ensure QA oversight of ongoing validation and lifecycle management for commercial processes.
• Lead QA support for regulatory inspections and audits of CMOs and critical suppliers.
• Provide QA input for regulatory submissions and post-approval changes related to CI, BI, and DS.
• Collaborate with Supply Chain to identify and mitigate quality-related risks.

Qualifications

• MSc degree in life sciences or equivalent.
• At least 10 years of experience in the pharmaceutical industry with a focus on GMP QA for commercial manufacturing.
• Strong knowledge of biologics manufacturing and experience with chemical intermediates is a plus.
• Proven experience with CMO oversight, quality agreements, and regulatory inspections.
• In-depth understanding of global GMP and ICH requirements.
• Excellent English communication skills and a pragmatic, risk-based QA approach.

Skills

What You’ll Gain

• Strong analytical and problem-solving skills.
• Ability to work collaboratively in a diverse team environment.
• Capacity to manage complex, supply-critical situations effectively.
• A role with significant impact on product quality and patient safety.
• Opportunities for strategic ownership and hands-on involvement in manufacturing activities.
• A culture that values quality, accountability, and continuous improvement.