Sr. Manager, Quality Assurance

About the position

The Sr. Manager, Quality Assurance is responsible for the development and management of the Quality Assurance team at Forge Biologics. The Quality Assurance team includes oversight of the GMP Manufacturing space as well as the laboratories. The Sr. QA manager will provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance. The Sr. QA Manager will also be responsible for establishing and improving the internal Quality policies that provide oversight of the GMP manufacturing area.

Responsibilities

• Must be thoroughly knowledgeable with pharmaceutical cGMP requirements including strong working knowledge of FDA and EU requirements / guidance documents.
• Partner with other technical groups to resolve issues, close gaps and seek quality compliant outcomes which are efficient and robust.
• Serves as a quality resource for operations departments.
• Responsible to make prompt, scientifically and/or statistically sound, quality / regulatory compliant decisions regarding products including material disposition decisions.
• Effectively communicate to management Quality issues that arise during the manufacturing of product.
• Proactively identify and implement items to enhance quality through continuous improvement (CAPA).
• Responsible for the authoring or review and approval of investigations, CAPAs and change controls to drive for resolution through root cause analysis.
• Responsible for the authoring or review and approval of controlled documentation including: Standard Operating Procedures (SOPs), Work Instructions, Forms, Methods, Batch Records, etc.
• Set clear vision by ensuring goals and objectives are aligned with site strategies and managing each team member's performance management.
• Provide leadership in employee relations by fostering effective communication, offering coaching and training, supporting development, and removing obstacles to facilitate team progress.
• Supports internal and external audits as needed.

Requirements

• Bachelor's Degree (B.A. or B.S.) in scientific-related field or engineering (or equivalent work experience).
• Experience in a Quality role in a GxP regulated industry.
• Direct experience in providing QA oversight for cGMP manufacturing operations.
• Knowledge of drug development regulations such as the GCPs, GMPs and GLPs.
• Previous leadership experience.
• Experience in supporting regulatory audits.
• Must be self-motivating, organized, and proactive.
• Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems.
• Ability to effectively communicate quality issues to senior leadership.
• Strong interpersonal skills to work with a diverse team.
• Ability to work hours necessary to support production and/or product transfer activities.
• Ability to work in confined spaces and near operating equipment.
• Comfortable working onsite 5 days/week.

Benefits

• Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents
• Flexible PTO (plus 14 paid company holidays)
• Annual bonus for all full-time employees
• 401(K) company match
• Fully-stocked kitchen with free food/drinks
• 12 weeks of paid parental leave - additional discount programs include childcare support & dependent care
• Employee Assistance Program
• Wellness benefits (financial planning services, mental health counseling, employer paid disability)
• Professional & Personal development resources - LinkedIn Learning, a dedicate training staff in-house, mentoring opportunities & access to leadership development coaches