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

The role

The Associate Manager supervises and develops junior Quality Assurance team members and oversees AAV GMP manufacturing activities. This role provides expertise and guidance to ensure compliance with regulatory requirements and maintains quality standards.

What you will do

• Serve as a quality resource for the GMP AAV Manufacturing department in the cleanroom environment
• Provide supervision for employee relations through coaching, training, and development
• Oversee timecard reporting, task oversight, and scheduling
• Perform detailed review and approval of batch records and associated documentation
• Collaborate with cross-functional teams to support continuous process improvement
• Support the documentation control process for batch records, SOPs, and work instructions
• Support deviations and continuous improvements through root cause analysis and CAPA
• Assist in the preparation for external audits and inspections

Required 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
• Thorough understanding of pharmaceutical cGMP requirements
• Strong working knowledge of FDA and EU requirements/guidance documents
• Experience using an Electronic Quality Management System
• Ability to collaborate with cross-functional technical groups
• Ability to manage competing priorities in a fast-paced, deadline-driven environment
• 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
• Ability to work in a GMP cleanroom environment wearing required PPE

Nice to have

• 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

Benefits

• Health, dental and vision insurance start your first day with 90% of premiums covered for you and your family
• Competitive paid time off plan
• 12 weeks of fully paid parental leave
• Annual bonus opportunities
• 401(k) with company match
• Special employee discounts, including childcare and dependent care savings
• Onsite fitness facility at The Hearth
• Mental health counseling and financial planning services through Employee Assistance Program
• Employer-paid short and long term disability coverage
• Fully stocked kitchen with free snacks and beverages
• Ongoing professional development resources, training, and mentorship programs

About the company

Forge Biologics aims to enable access to life-changing gene therapies. The team works out of The Hearth, a 200,000-square-foot cGMP facility in Columbus, Ohio.