Forge Biologics · 5 hours ago
Lead, QA Operations
Columbus, OH
Full-time
Onsite
Senior Level
6+ years expForge Biologics is focused on enabling access to life-changing gene therapies. The Lead, Quality Assurance Operations will supervise junior QA team members and oversee GMP manufacturing activities, ensuring compliance with regulations and internal policies.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Serves as a quality resource for operations departments
Responsible to make fact-based, scientifically and/or statistically sound, quality / regulatory compliant decisions regarding products
Perform detailed review and approval of batch production records and associated documentation for AAV gene therapy manufacturing, ensuring adherence to established procedures and cGMP regulations
Effectively communicate to management Quality issues that arise during the manufacturing of product
Proactively identify and implement items to enhance quality through continuous improvement (CAPA)
Responsible for the leading, authoring, and reviewing of investigations, CAPAs and change controls to drive for resolution through root cause analysis
Responsible for the review and approval of controlled documentation including Standard Operating Procedures (SOPs), Work Instructions, Forms, Methods, Batch Records, etc
Develop and deliver comprehensive training programs to QA and manufacturing personnel on quality-related topics, ensuring proper understanding and adherence to AAV gene therapy manufacturing procedures and regulatory requirements
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 as well as create and report metrics and internal KPIs
Provide supervision for employee relations through effective communications, coaching, training and development and eliminate roadblocks for the team to move forward
Supports regulatory audits as needed
Qualification
Required
Bachelor's Degree (B.A. or B.S.) in scientific-related field or engineering (or equivalent work experience)
6-8 years in a quality assurance 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
Experience in supporting internal and external audits
Thorough understanding of pharmaceutical cGMP requirements and strong working knowledge of FDA and EU requirements/guidance documents
Direct experience in providing QA support for cGMP manufacturing operations
Knowledge of drug development regulations such as the GCPs, GMPs and GLPs
Proficiency in electronic quality management systems (eQMS) and document control software
Strong analytical and problem-solving skills, with the ability to analyze complex quality-related data and propose effective solutions
Ability to collaborate with diverse cross-functional technical groups to resolve issues, close gaps and ensure compliant outcomes which are efficient and robust
Excellent communication skills, including the ability to effectively communicate quality issues to senior management
Exceptional attention to detail and organizational skills to manage multiple priorities in a fast-paced environment
Ability to work hours necessary to support production and/or product transfer activities
Ability to work in confined spaces and near operating equipment
Ability to work onsite (Columbus, Ohio) 5 days/week
Ability to work in a cleanroom environment while wearing appropriate gowning and PPE
Benefits
Health, dental and vision insurance start your first day – with 90% of premiums covered for you and your family.
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.
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.
A fully stocked kitchen with free snacks and beverages – we keep you energized and ready for what’s next.
Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.
Company
Forge Biologics
Forge Biologics is a gene therapy development engine, enabling access to life changing gene therapy programs.
201-500 employees
H1B Sponsorship
Forge Biologics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (4)
2023 (2)
2022 (1)
Funding
Current Stage
Growth StageTotal Funding
$330MKey Investors
State of OhioMidCap FinancialRA Capital Management
2023-11-13Acquired
2022-09-12Series C· $90M
2022-01-10Grant
Leadership Team
Timothy J. Miller, Ph.D. (he/him)
Cofounder, President & CEO
Erandi De Silva, PhD
Co-founder, Senior Vice President of Product Development
Recent News
2025-12-24
Coherent Market Insights Pvt. Ltd
2025-12-03
Company data provided by crunchbase