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

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 of  H.O.P.E.  We are  hardworking , showing up each day with determination and grit. We are  open , creating a space where ideas flow freely, and every voice is valued. We are  purpose-driven , with every task directly tied to changing lives. And we are  engaged , 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.

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.