Job summary
Seeking an experienced QA Specialist to lead quality assurance efforts in the introduction of new products within a global pharmaceutical manufacturing environment. The role focuses on ensuring compliance with GMP and regulatory standards through oversight of technology transfer to external manufacturing partners, managing quality documentation, and supporting investigational product manufacturing for clinical trials.
Location and work setup
- Location
- Norway
- Work setup
- Hybrid
Salary
EUR 56000.00–77000.00 year
Responsibilities
Lead QA oversight for new product introduction activities ensuring GMP and regulatory compliance. Manage technology transfer processes to contract manufacturing organizations including review and approval of protocols and risk assessments. Ensure external manufacturing sites remain inspection-ready and compliant. Act as the QA lead collaborating with external partners to uphold quality standards. Review and approve GMP documentation such as batch records, deviations, CAPAs, and validations. Monitor partner performance via quality metrics, audits, and governance. Support product supply to clinical trials and pharmaceutical partners. Interface during audits and inspections while partnering with global cross-functional teams for program delivery. Apply quality risk management and drive continuous improvement in manufacturing quality processes. Conduct on-site CMO visits to support QA oversight.
Qualifications
Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or related field. Demonstrated experience in Quality Assurance within GMP regulated environments. Proven expertise in new product introduction, technology transfer, validation, and working with contract manufacturing organizations. Strong knowledge of global regulatory frameworks including FDA, EMA, and ICH guidelines. Excellent communication, stakeholder management, problem-solving, and compliance skills. Ability to work effectively within a global, matrixed organization and willingness to travel (~10-25%).