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Forge Biologics is seeking a Compliance Specialist Lead to drive strategy and delivery for Regulatory and Quality Compliance Initiatives at their state-of-the-art cGMP manufacturing facility in Columbus, Ohio. This role oversees the GMP Internal Audit program and supports improvement initiatives related to Quality Management Review (QMR), external audit programs, and processes to ensure compliance with regulatory agency requirements, internal standards, client requirements, and current Good Manufacturing Practices (cGMPs).
Key responsibilities include:
- Ownership of the internal audit process, including planning, execution, and verification of corrective actions
- Support regulatory compliance and quality representatives by applying regulatory knowledge to identify compliance concerns and remediation actions
- Track corrective actions from audit observations and review objective evidence as actions are completed
- Support and update site governance, standard operating procedures, training content and delivery; promote an audit/inspection-ready culture
- Support coordination of Management Review, including monitoring quality system health through KPI evaluation, effectiveness checks, and risk management
- Partner with internal departments (Manufacturing, Quality, Facilities, Engineering) to ensure end-to-end compliance throughout the product lifecycle
- Champion quality and compliance practices throughout the organization
Forge Biologics manufactures AAV gene therapies and partners with scientists, physicians, biotech and pharma innovators, and patient communities to bring life-changing therapies to market. The company operates from The Hearth, a 200,000-square-foot cGMP facility in Columbus.
Qualifications (from posting):
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