Forge Biologics is seeking a Senior Manager, Quality Systems to manage and improve the Quality Systems at the company. The ideal candidate will have 10+ years of relevant experience in Quality Systems within an FDA regulated field/industry and prior leadership experience. The role will involve providing expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to ensure compliance. The Senior Manager, Quality Systems will be responsible for establishing and improving the internal Quality Systems business practices and workflows at Forge.
Requirements
- Manage quality events and continuous improvement of the Quality Systems
- Facilitate the compiling, trending and reporting of key quality metrics for management
- Responsible for implementation and compliance to schedule, conduct, and document Management Review
- Communicate with other technical groups to resolve issues
- Responsible for the authoring or review and approval of controlled documentation
- Support hosting client/regulatory inspections
- Qualifications:
- Bachelor’s Degree in Biology, Biochemistry, Biomedical Engineering, or related life science field (or equivalent professional experience)
- 10+ years of relevant experience Quality Systems within an FDA regulated field/industry
- Prior leadership experience
- Experience supporting inspections performed by FDA and/or foreign regulatory authorities
- In-depth expertise in deviation management, change control, CAPA, and root cause analysis
- Strong understanding of Quality Risk Management practices and procedures
- Thorough knowledge of pharmaceutical cGMP requirements including strong working knowledge of FDA and EU requirements/guidance documents
- Proficiency in Quality Management Systems such as Veeva Vault QMS
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- Paid time off
- Parental leave
- Annual bonus opportunities
- 401(k) with company match
- Employee discounts
- Onsite fitness facility
- Mental health counseling
- Financial planning services
- Disability coverage
