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 involves 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.
• Proven ability to deliver compliant and timely solutions with a structured and results-oriented approach.
• Excellent communication skills, both written and verbal, with the ability to interact effectively with external suppliers and partners; willingness to travel as needed.

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 the review and approval of GMP documentation.
• Maintain and enhance the Quality Management System within the GMP area, including processes and training.
• Support Health Authority inspections and partner audits through preparation and documentation review.

Skills

• Strong compliance judgment and stakeholder communication skills.
• Ability to build trusted relationships while overseeing suppliers and partners in an outsourced setup.

Education

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

Tools

• Familiarity with GMP documentation and Quality Management Systems.