Quality Assurance Manager
3 days ago
The Manager, Quality Assurance is a critical position at Forge Biologics, responsible for overseeing the development and management of the Quality Assurance team. This team is responsible for ensuring compliance with governmental regulations, agency guidelines, and internal policies in the GMP Manufacturing space and laboratories.
Key Responsibilities- Provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to ensure compliance.
- Establish and improve internal Quality policies that provide oversight of the GMP manufacturing area.
- Partner with other technical groups to resolve issues, close gaps, and seek quality-compliant outcomes.
- Serve as a quality resource for operations departments.
- Make prompt, scientifically and/or statistically sound, quality/regulatory-compliant decisions regarding products, including material disposition decisions.
- Effectively communicate quality issues to management.
- Proactively identify and implement items to enhance quality through continuous improvement (CAPA).
- Author or review and approve investigations, CAPAs, and change controls to drive resolution through root cause analysis.
- Author or review and approve 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.
- Support internal and external audits as needed.
- Bachelor's Degree (B.A. or B.S.) in a 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.
- Experience in supporting regulatory audits.
- 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.
This position works in both a laboratory environment and typical office environment, with physical work demands varying depending on specific tasks and duties. The employee will be stationary (standing/sitting) for extended periods. 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.
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.
About Forge BiologicsForge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. We provide equal employment opportunities to all employees and applicants for employment and prohibit discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
We are a team of diverse, driven, and passionate people working together to trailblaze a new model for how we make medicines to treat patients with genetic diseases. Our team members use their creativity and talent to invent new solutions, meet new demands, and offer the most effective services in the industry. Forge's core values lay the foundation for H.O.P.E., providing us a common purpose that we all understand, work towards, and live by.
H.O.P.E. stands for:
- HARDWORKING - We work hard and smart, making a persistent and determined effort toward success.
- OPEN - We strive to be approachable, actively listen, and encourage others to contribute and speak up.
- PURPOSE DRIVEN - We are passionate about working towards and delivering on our mission to manufacture gene therapies.
- ENGAGED - We are fully absorbed by and enthusiastic about our work and take positive action to further Forge's vision, mission, and goals.
- Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members and 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 dedicated training staff in-house, mentoring opportunities, and access to leadership development coaches.
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