We are seeking a Quality Project Manager to lead and coordinate the end-to-end process for New Product Introductions within a GMP-regulated environment. In this role, you'll serve as the quality lead, managing project milestones, documentation, and cross-functional collaboration to bring new pharmaceutical or medical device products from concept through to commercialization.
This is a newly created role due to growth and offers the opportunity to take ownership of a high-impact process, with visibility across Quality, Regulatory, R&D, Manufacturing, and Supply Chain functions.
Key Responsibilities
- Drive planning, execution, and oversight of NPI projects ensuring alignment with quality, regulatory, and business goals.
- Own and manage the NPI checklist and documentation process, ensuring completion of each project phase.
- Create and manage a SharePoint site to track project activities (future transition to MasterControl).
- Lead lab-related activities, including sterilization, clean studies, shipping studies, and stability testing setup.
- Serve as the key quality liaison across departments and external partners.
- Coordinate design, development, testing, production, and launch activities with stage-gate reviews.
- Prepare and review validation protocols, deviations, CAPAs, and regulatory submission documents.
- Support technology transfer and ensure smooth transition to commercial manufacturing.
- Participate in audits, inspections, and regulatory engagements related to NPI.
- Promote a strong quality culture and continuous improvement mindset.
Requirements:
- 5-10 years of experience in Quality Assurance, Engineering, or Project Management within a GMP-regulated pharma or medical device environment.
- Familiarity with ISO standards and the ability to read/interpret regulatory documentation.
- Strong project ownership skills with the ability to manage timelines, stakeholders, and documentation.
- Excellent communication, attention to detail, and ability to hold cross-functional teams accountable.
- Experience with stability testing and other lab-based quality validation activities.
- Comfortable managing complex documentation processes (e.g., multi-page forms, stage-gate approvals).
Why Join Us?
- Opportunity to step into a newly created role with strong executive support
- Potential to grow into a senior-level title
- Chance to drive process automation and future enhancements
- High-impact position with visibility across product lifecycle functions