Associate Manager, QA Operations - AAV Manufacturing (2nd Shift)

Forge Biologics

Columbus (OH)

On-site

USD 110,000 - 160,000

Full time

3 days ago

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Benefits offered by this job

Health insurance

401(k) with company match

Annual bonus opportunities

Onsite fitness facility

Job summary

Forge Biologics is seeking an Associate Manager of QA Operations for AAV Manufacturing on the 2nd shift in Columbus, OH. This role leads junior QA staff, ensures cGMP compliance, and facilitates batch record reviews within a state-of-the-art AAV production environment.

The candidate will partner with Process Development and Manufacturing to drive continuous improvements, manage deviations, CAPAs, and support internal/external audits.

Qualifications

Bachelor’s Degree in scientific field or engineering.
6+ years in QA or related role in pharma/biotech.
Experience mentoring junior team members and QA best practices.
Strong knowledge of cGMP and FDA/EU guidance documents.
Experience with electronic QMS (Veeva Vault preferred).
Ability to collaborate cross-functionally to resolve issues and ensure compliant outcomes.

Responsibilities

Oversee GMP AAV Manufacturing operations in cleanroom environment and communicate quality issues.
Supervise QA team, manage timecards, training and scheduling.
Review batch records and maintain controlled documentation per procedures and cGMP.
Collaborate with Process Development, Analytical Development, and Manufacturing for process improvements.
Support deviations and CAPA with root cause analysis.
Assist in external audits and inspections for AAV gene therapy manufacturing.

Skills

QA leadership

GMP compliance

Cross-functional collaboration

Document control

FDA/EU guidelines

CAPA/root cause analysis

Education

Bachelor’s Degree in science/engineering

Tools

Veeva Vault

Electronic Quality Management System

Job description

Associate Manager, QA Operations - AAV Manufacturing (2nd Shift)

Columbus, Ohio

Forge Your Future with Us:

At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities — all united by one goal: improving lives. If you’re driven by purpose and excited to make a tangible impact, this is where your journey begins.

Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won’t just watch innovation happen — you’ll be part of it. Whether you’re scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you’ll play a key role in bringing hope to patients with genetic diseases.

What sets Forge apart is our culture ofH.O.P.E.We arehardworking, showing up each day with determination and grit. We areopen, creating a space where ideas flow freely, and every voice is valued. We arepurpose-driven, with every task directly tied to changing lives. And we areengaged, energized by the challenges we face and the milestones we achieve together.

At Forge, your growth matters. We’re committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands-on learning, and opportunities for advancement. Our people are our greatest investment, and we’re proud to see team members grow with us.

If you’re ready to use your talent to help deliver hope to patients around the world, join us — and be part of something bigger than yourself.

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 maintain ing 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 Q uality A ssurance 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.

Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits 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.

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 youandyour 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.
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