About The Role: The
Associate Manager, Quality Assurance - AAV Manufacturing is responsible for the supervision and development of junior members of the Quality Assurance team and helping oversee AAV GMP manufacturing activities. The Associate Manager will provide expertise and guidance, ensuring compliance with regulatory requirements and maintaining the highest quality standards. The Associate Manager will supervise junior members of the Quality Assurance team in activities such as document control, batch record review, and maintaining a QA presence in AAV gene therapy manufacturing areas.
Responsibilities:- Serve as a quality resource for the GMP AAV Manufacturing department directly overseeing operations in the cleanroom manufacturing environment, providing guidance and effective communication of Quality issues that arise during the manufacturing of product by making make fact-based, data driven, compliant decisions regarding products and process.
- Provide supervision for employee relations through effective communication, coaching, training and development and eliminate roadblocks for the team to move forward. Assist management in setting clear vision by ensuring goals and objectives are aligned with departmental goals and supervising each junior team member's team support. Oversee timecard reporting, task oversight, and scheduling.
- Perform detailed review and approval of batch records and associated documentation for AAV gene therapy manufacturing, logbooks, and other controlled documentation ensuring adherence to established procedures and cGMP regulations.
- Collaborate with cross-functional teams, including Process Development, Analytical Development, and Manufacturing, to support continuous process improvement initiatives and ensure alignment with quality objectives.
- Support the documentation control process for AAV gene therapy manufacturing, including creation, revision, review, and approval of batch records, SOPs, work instructions, and forms to ensure compliance with regulatory requirements and industry best practices.
- Support deviations and continuous improvements related to AAV gene therapy manufacturing processes, assist with root cause analysis and identification of CAPA measures to prevent recurrence.
- Assist in the preparation for external audits and inspections, supporting regulatory agencies or client audits specific to AAV gene therapy manufacturing.
Qualifications:- Bachelor's Degree (B.A. or B.S.) in scientific-related field or engineering (or equivalent work experience).
- 6+ years in a Quality Assurance or related role within the pharmaceutical or biotechnology industry.
- Experience mentoring and developing junior team members, including providing guidance on QA best practices and fostering professional growth.
- Thorough understanding of pharmaceutical cGMP requirements and strong working knowledge of FDA and EU requirements/guidance documents.
- Experience using an Electronic Quality Management System, preferably Veeva Vault or a comparable document management platform.
- Ability to collaborate with cross-functional technical groups to resolve issues, close gaps, and ensure compliant outcomes which are efficient and robust.
- Ability to manage competing priorities in a fast-paced, deadline-driven environment while maintaining accuracy, completeness, and compliance.
- Proficiency with Microsoft Office applications, including Outlook, Teams, Word, Excel, and PowerPoint.
- Ability to work the hours necessary to support production and participate in an on-call rotation providing off-hours support for AAV manufacturing needs and issues.
- Ability to work in a GMP cleanroom environment as needed to support manufacturing operations, including wearing required PPE such as gowns, gloves, masks, and safety glasses.
Preferred Skills:- Direct experience in providing QA support for cGMP manufacturing operations in a cleanroom environment.
- Experience working in the production of biologics (ex. gene therapies).
- Familiarity with CDMO operations and client-driven project timelines.
- Experience supporting internal audits and participating in external audits or inspections.
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 is performed in a temperature-controlled laboratory or office environment and requires regular standing, hand manipulation, and use of laboratory equipment. The role may involve lifting or moving materials up to 25 pounds and occasional reaching or handling at various heights. Appropriate personal protective equipment (PPE) must be worn when working with chemicals, biological materials, or in controlled environments.
We’ve Got You Covered: At Forge Biologics, we believe our people deserve to be taken care of - in and out of the workplace. We’ve built a comprehensive compensation and benefits package designed to help you thrive, grow, and feel valued every step of the way:
Health from day one- Health, dental and vision insurance start your first day - with 90% of premiums covered for you and your family.
Time to recharge- A competitive paid time off plan - because rest fuels innovation.
- 12 weeks of fully paid parental leave so you can focus on family when it matters most.
Rewarding your impact- Annual bonus opportunities for all full-time team members.
- 401(k) with company match to help you plan for the future.
- Special employee discounts, including childcare and dependent care savings.
Your wellness, supported- Onsite fitness facility at The Hearth.
- Mental health counseling and financial planning services through our Employee Assistance Program.
- Employer-paid short and long-term disability coverage to protect your peace of mind.
Fuel for your workday- A fully stocked kitchen with free snacks and beverages - we keep you energized and ready for what's next.
Grow with us- Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.
