Compliance Specialist Lead

Forge Biologics•Columbus, OH

5d•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), the External Audit program, and processes that ensure compliance with regulatory agency requirements, internal company standards, client requirements, and current Good Manufacturing Practices (cGMPs). The position partners with internal departments to support end-to-end compliance throughout the product lifecycle and commercial readiness, and promotes a strong quality and compliance culture. Work is primarily office-based, with extended computer use and regular interaction with internal teams and external stakeholders. When on-site, safety requirements and PPE may apply.

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 against prescribed commitments.
Support and update Site Governance, Standard Operating Procedures, training, and related content and delivery.
Promote an audit- and inspection-ready culture.
Support coordination of Management Review, monitoring overall Quality System health through evaluation of KPIs, effectiveness checks, and risk management.
Partner with internal departments, including Manufacturing, Quality, Facilities, and Engineering, to ensure end-to-end compliance throughout the product lifecycle and commercial readiness.
Model good 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.