Job summary
Seeking an experienced Quality Assurance professional to lead new product introduction activities within a global manufacturing network. The role involves overseeing technology transfers to external manufacturers, ensuring GMP compliance, and supporting clinical trial-related product manufacturing. The position requires collaboration with cross-functional global teams and managing quality standards across external partners.
Location and work setup
- Location
- Lindesnes
- Work setup
- Hybrid
Responsibilities
Lead quality assurance oversight for new product implementation ensuring adherence to GMP and regulatory standards. Manage technology transfers to contract manufacturing organizations, including protocol and risk assessment approvals. Ensure external sites maintain inspection readiness and compliance. Oversee GMP documentation, monitor manufacturing performance through audits and quality metrics, and manage deviations and CAPA processes. Act as quality interface during audits and inspections, contribute to project governance and risk management, and drive continuous improvement of manufacturing quality processes. Conduct on-site visits to support technology transfers and quality oversight.
Qualifications
Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or related field. Demonstrated experience in quality assurance within GMP environments, particularly involving new product introduction, technology transfer, validation, or external manufacturing. Familiarity with working alongside contract manufacturing organizations and knowledge of global regulatory requirements (FDA, EMA, ICH). Strong communication, stakeholder management, problem-solving skills, and a detail-oriented, compliance-focused mindset. Willingness to travel approximately 10-25%. No Norwegian language requirement indicated.