CMC Program Manager
Company: QCS Staffing Agency
- Location: Oslo, Norway
- Seniority: Mid level
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
CMC Program Manager – Norway – Initial 12-Month Contract – Life Sciences
Our client is undergoing major growth, supported by substantial investment aimed at increasing its overall manufacturing capacity in the medical device sector. Recent upgrades include the development of new, advanced automation systems and additional infrastructure enhancements designed to meet growing global healthcare demands.
With a long‑established presence and a highly skilled workforce, the site requires the role of a CMC Program Manager to support their project based in Norway.
What You’ll Deliver
- Lead CMC programmes from development through regulatory submission, approval and implementation.
- Develop and maintain the integrated programme plan, critical path, milestones, budget and resource requirements.
- Coordinate formulation, analytical development, stability, process development, validation, manufacturing readiness and regulatory activities.
- Partner with Regulatory Affairs to drive submission readiness, health-authority responses and approval timelines and clear risk communication.
Experience required:
- Bachelor's or advanced degree in Pharmacy, Chemistry, Pharmaceutical Sciences, Chemical Engineering or related discipline.
- Significant pharmaceutical industry experience, including leadership of complex CMC or product-development programmes.
- Strong understanding of pharmaceutical development, GMP, CMC requirements and global regulatory submissions.
- Demonstrated experience coordinating multidisciplinary teams through major development and regulatory milestones.
- Strong programme planning, risk management, stakeholder management and executive communication skills.
If this assignment is of interest, apply now!
