Senior Manager, Quality Systems

About The Role:

The Senior Manager, Quality Systems is responsible for the management and improvement of the Quality Systems at Forge Biologics. This individual will provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to ensure compliance. The Senior Manager, Quality Systems will also be responsible for establishing and improving the internal Quality Systems business practices and workflows at Forge.

Responsibilities:

• Manage quality events and continuous improvement of the Quality Systems including Investigations, Continuous Improvements, CAPAs, Change Controls, and other quality systems implemented at Forge.
• Facilitate the compiling, trending and reporting of key quality metrics for management, and other quality system functions.
• Responsible for implementation and compliance to schedule, conduct, and document Management Review, including preparation of the Management Review Agenda and Minutes.
• Communicate with other technical groups to resolve issues, identify and close gaps, and seek quality compliant outcomes which are efficient and robust.
• Responsible for the authoring or review and approval of controlled documentation including: Standard Operating Procedures (SOPs), Work Instructions, Guidance’s, and other controlled document types.
• Making fast-based, scientifically and/or statistically sound, quality/regulatory compliant decisions that have impact on product release.
• Support hosting client/regulatory inspections, inspection readiness training, and reviewing audit reports and responses, as needed.

Qualifications:

• Bachelor’s Degree (B.A. or B.S.) 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.
• Ability to work onsite in Columbus, Ohio, on average 1 week/month.

_This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change, or new ones may be assigned._

Work Environment and Physical Demands

This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area.