Quality Control Manager
16 hours ago
About the Role:
We are seeking a highly skilled and experienced Manager, Quality Control (QC), Microbiology (Micro) and Environmental Monitoring (EM) to join our team at Forge Biologics. As a key member of our Quality team, you will be responsible for overseeing the daily operations of the QC, Micro/EM Department, ensuring compliance with cGMP standards, and driving quality excellence in our gene therapy manufacturing processes.
Key Responsibilities:
- Manage the overall operations in the QC Micro Lab, ensuring regulatory compliance and State, Federal, and Corporate compliance.
- Responsible for micro testing of raw materials, in-process materials, finished product, and various environment/utility tests.
- Manage the EM Program (EM sampling and testing) and EM Analysts.
- Oversee data generated by the QC, Micro/EM team and ensure timely completion of trending reports per required frequency.
- Develop, implement, and monitor QC, Micro/EM methods and documents (e.g., SOPs, Work Instructions, etc.).
- Assess and implement continuous improvement of lab efficiency and the EM program.
- Represent the QC Micro/EM function for all external quality and regulatory audits.
- Responsible for GMP compliance, manufacturing quality, laboratory support, and quality planning.
- Hire and retain a diverse, highly qualified staff and provide ongoing performance feedback.
Requirements:
- Bachelor's Degree in Biology, Microbiology, or related discipline.
- 2-3 years of direct supervisory or management experience.
- Experience leading micro/environmental monitoring efforts in a Pharma, Biotech, or regulated/GxP industry.
- Good aseptic technique is essential for this position.
- Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Preferred Skills:
- Experience working with contract labs, including contract management, operational oversight, and business process integrations.
- Experience with electronic Quality Management Systems (EQMS), Laboratory Information Management Systems (LIMS), etc.
- Experience in high-level interactions with domestic and international Regulatory agencies.
- Experience in cell and gene therapy (e.g., AAV manufacturing).
- Experience in compendia microbiological testing methods.
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.
About Forge Biologics:
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. It provides us a common purpose that we all understand, work towards, and live by.
H.O.P.E. Values:
- 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.
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.
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