Compliance Specialist Lead

Forge Biologics•Columbus, OH

3d•Onsite

About The Position

Forge Biologics is seeking a Compliance Specialist Lead to drive the strategy and delivery of Regulatory and Quality Compliance initiatives and oversee the GMP Internal Audit program. The role supports improvements to the Quality Management Review (QMR) and the External Audit program, helping ensure compliance with regulatory agency requirements, company standards, client requirements, and current Good Manufacturing Practices (cGMPs). The position works with internal teams including Manufacturing, Quality, Facilities, and Engineering to support end-to-end compliance across the product lifecycle and commercial readiness. It also promotes audit and inspection readiness and a strong quality culture. The role is primarily office-based, with extended computer use and occasional site activity.

Requirements

Bachelor’s degree in a related discipline.
At least 5 years of compliance experience in a regulated industry, such as regulatory compliance experience in pharmaceutical, biotech, or biologics GMP-regulated manufacturing.
Excellent analytical, communication, and problem-solving skills.
Proven ability to manage multiple priorities in a fast-paced environment.
Experience interacting with domestic and international regulatory agencies.
Working knowledge of quality systems and ability to apply GMPs in conformance with U.S. and global standards and, where appropriate, other regulatory authority standards.

Nice To Haves

American Society for Quality CQA or equivalent certification.
Project or program management experience.

Responsibilities

Own the Internal Audit process, including planning, execution, and verification of actions.
Support Regulatory Compliance and Quality representatives, applying regulatory knowledge and judgment to identify potential compliance concerns and remediation actions.
Track corrective actions arising from audit observations and review objective evidence as actions are completed in accordance with prescribed commitments.
Support and update Site Governance, Standard Operating Procedures, training, and content delivery.
Promote an audit- and inspection-ready culture.
Support coordination of Management Review, including monitoring Quality system health through KPI evaluation, effectiveness checks, and risk management.
Partner with Manufacturing, Quality, Facilities, and Engineering to ensure end-to-end compliance throughout the product lifecycle and commercial readiness.
Model sound quality and compliance practices and champion Quality Culture throughout the organization.

Benefits

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