Overview In this role you will lead QC for clinical and commercial products, shaping the QC strategy and roadmap across GMP operations. You will manage a growing QC team and collaborate with CMC to support product release and expiry decisions. Your work ensures compliance with regulatory standards across internal and external facilities while driving continuous improvement. This position offers a chance to influence product quality for a diverse pipeline and impact both clinical and commercial programs.
Compensation / Benefits- medical insurance
- dental insurance
- vision insurance
- life insurance
- 401(k) with company match
- paid holidays
Responsibilities- Lead QC activities for clinical and commercial products, including in-process and release testing of GMP products
- Manage and develop QC staff, including hiring, coaching, and performance planning
- Oversee stability planning and data analysis for expiry/shelf-life determination
- Ensure compliance with cGMP at external CMOs and testing organizations
- Oversee release of QC components in GMP batch/test records and COA generation
- Develop QC strategy with analytical method development and manufacturing processes via Omeros Technical CMC teams
- Transfer, qualify, and validate analytical methods with internal/external stakeholders
- Establish QC standards for clinical and commercial phases
- Draft/review regulatory filing sections related to QC
- Lead continuous improvement projects with internal/external partners
Key requirements- 10+ years of Quality Control experience in biotech/pharma
- Strong knowledge of GMP, ICH and Quality Management Systems
- Experience with analytical method transfer to third parties
- Regulatory interactions and GMP inspections experience
- Analytical method development and validation expertise
- Stability testing and expiry setting experience
- Experience with injectable and oral dosage forms preferred
- Big pharma/biotech background; startup experience desirable
- Proficiency in MS Office; statistical analysis software desirable
- Strong leadership and people management
- Excellent written and oral communication
- Collaborative and relationship-building abilities
- Analytical method development and validation
- Stability testing and data trending
- cGMP regulatory compliance at CMOs
