QA Manager (Pharmaceutical, Copenhagen)

Job summary

The QA Manager for Drug Substance will oversee quality assurance for drug substance development and GMP manufacturing at external contract manufacturing organizations (CMOs). This role requires collaboration with internal teams and external partners to ensure compliance and effective issue resolution while maintaining robust GMP execution.

Qualifications

• Master's degree in life sciences, pharmacy, or a related field.
• Several years of experience in drug substance GMP operations within the pharmaceutical sector.
• Experience in Quality Assurance for drug substance development and manufacturing in an outsourced environment.
• Strong understanding of GMP requirements and Quality Systems in pharmaceutical development and manufacturing.
• Proven ability to deliver compliant and timely solutions with a structured and approachable work style.
• Excellent communication skills, both written and verbal, with a willingness to travel as necessary.

Responsibilities

• Provide QA oversight and quality guidance for drug substance development and GMP manufacturing at CMOs.
• Collaborate with internal development functions and external partners to ensure compliance and effective issue resolution.
• Participate in CMC project teams, offering operational QA input to plans and risk assessments.
• Conduct drug substance release activities, including review and approval of GMP documentation.
• Maintain and enhance the Quality Management System within the GMP area.
• Support Health Authority inspections and partner audits, including readiness activities and documentation review.

Skills

• Strong compliance judgment and stakeholder communication skills.
• Ability to build trusted relationships while ensuring appropriate QA oversight.

Education

• Master's degree in life sciences, pharmacy, or similar.

Tools

• Familiarity with GMP documentation and Quality Management Systems.