{"id":1974778,"url":"https://alion.io/job/forge-biologics-associate-manager-qa-operations-aav-manufacturing-2nd-shift","title":"Associate Manager, QA Operations - AAV Manufacturing (2nd Shift)","company":{"id":673246,"name":"Forge Biologics","domain":"forgebiologics.com","url":"https://alion.io/company/forgebiologics","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Management","role_family":"Management","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Columbus, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":55000,"max_usd":102000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":1467},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Outlook","optional":false}],"status":"live","first_seen_at":"2026-10-06T20:34:03Z","employer_posted_date":"2026-10-12","last_verified_at":"2026-10-21T03:30:39Z","board_verified":true,"closed_at":null,"days_open":14,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":14},"description":"Forge Your Future with Us:\nAt 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.\nOur 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.\nWhat 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.\nAt 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.\nIf 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.\nAbout The Role: \nTheAssociate Manager, Quality Assurance - AAV Manufacturing is responsible forthe supervision and developmentofjunior members ofthe Quality Assurance team and helping oversee AAV GMP manufacturing activities. The Associate Managerwill provide expertiseand guidance,ensuring compliance with regulatory requirements and maintainingthe highest quality standards. The AssociateManagerwill supervise junior members of the Quality Assurance team in activities such as document control, batch record review, and maintaininga QA presence in AAV gene therapy manufacturing areas. \nResponsibilities:\nServe 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. \nProvide supervision for employee relations through effective communication, coaching, trainingand development and eliminateroadblocks for the team to move forward.Assistmanagement in setting clear visionby ensuring goals and objectivesare aligned with departmental goals and supervising each junior team member’s team support. Overseetimecard reporting, task oversight, and scheduling. \nPerform detailed review and approval of batch records and associated documentation for AAV gene therapy manufacturing, logbooks, and other controlled documentation ensuring adherence to establishedprocedures and cGMP regulations. \nCollaborate with cross-functional teams, including Process Development, Analytical Development, and Manufacturing, to support continuous process improvement initiatives and ensure alignment with quality objectives. \nSupport 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. \nSupport deviations and continuous improvements related to AAV gene therapy manufacturing processes, assistwith root cause analysis and identification of CAPA measures to prevent recurrence. \nAssistin the preparation for external audits and inspections, supporting regulatory agencies or client audits specific to AAV gene therapy manufacturing. \nQualifications:\nBachelor’s Degree (B.A. or B.S.) in scientific-related field or engineering (or equivalent work experience). \n6+years in a Quality Assurance or related role within the pharmaceutical or biotechnology industry. \nExperience mentoring and developing junior team members, including providing guidance on QAbest practices and fostering professional growth. \nThorough understanding of pharmaceutical cGMPrequirements and strong working knowledge of FDA and EU requirements/guidance documents. \nExperience using an Electronic Quality Management System, preferably Veeva Vault or a comparable document management platform. \nAbility to collaborate with cross-functional technical groups to resolve issues, close gaps,and ensure compliant outcomes which are efficient and robust. \nAbility to manage competing priorities in a fast-paced, deadline-driven environment while maintaining accuracy, completeness, and compliance. \nProficiency with Microsoft Office applications, including Outlook, Teams, Word, Excel, and PowerPoint. \nAbility to work the hours necessary to support production and participatein an on-call rotation providing off-hours support for AAV manufacturing needs and issues. \nAbility to work in a GMP cleanroom environment asneeded to support manufacturing operations, including wearing required PPE such as gowns, gloves, masks, and safety glasses. \nPreferred Skills:\nDirect experience in providing QA support for cGMP manufacturing operations in a cleanroom environment. \nExperience working in the production of biologics (ex. gene therapies). \nFamiliarity with CDMO operations and client-driven project timelines. \nExperience supporting internal audits and participatingin external audits or inspections. \nThis 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. \nWork Environment and Physical Demands \nThis 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. \nForge 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. \nWe’ve Got You Covered: \nAt 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:\nHealth from day one\nHealth, dental and vision insurance start your first day - with 90% of premiums covered for you and your family.\nTime to recharge\nA competitive paid time off plan - because rest fuels innovation.\n12 weeks of fully paid parental leave so you can focus on family when it matters most.\nRewarding your impact\nAnnual bonus opportunities for all full-time team members.\n401(k) with company match to help you plan for the future.\nSpecial employee discounts, including childcare and dependent care savings.\nYour wellness, supported\nOnsite fitness facility at The Hearth.\nMental health counseling and financial planning services through our Employee Assistance Program.\nEmployer-paid short and long-term disability coverage to protect your peace of mind.\nFuel for your workday\nA fully stocked kitchen with free snacks and beverages - we keep you energized and ready for what’s next.\nGrow with us\nOngoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.","description_format":"text","description_chars":8314,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Parental leave","Professional development","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Cell & Gene Therapy","CRO & CDMO Services","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-06T20:57:05Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 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