Compliance Specialist Lead

Job overview

The Compliance Specialist Lead role is an onsite, full-time position in Columbus, OH. Compensation is not specified. Forge Biologics works to enable access to gene therapies and bring them from ideas into reality. The role leads regulatory and quality compliance initiatives and oversees the Good Manufacturing Practice internal audit program. It supports audit readiness, corrective-action follow-through, quality management review, and cross-functional compliance across the product lifecycle.

What you'll do

• Own internal audit planning, execution, and action verification
• support regulatory compliance and quality representatives in identifying concerns and remediation
• track audit corrective actions and review evidence
• support site governance, standard operating procedures, and training
• coordinate management review and monitor quality-system KPIs and risks
• partner with Manufacturing, Quality, Facilities, and Engineering to support compliance and commercial readiness
• promote quality culture.

What we're looking for

Skills & competencies

compliance specialist lead

regulatory compliance

quality compliance

gmp

internal audits

corrective actions

quality management review

columbus oh

forge biologics

full-time

audit readiness

quality systems

Work arrangement

• Weekend coverage required

Benefits & perks

• Health, dental, and vision insurance with 90% of premiums covered for employee and family
• paid time off
• 12 weeks paid parental leave
• annual bonus opportunities for full-time employees
• 401(k) match
• employee discounts
• onsite fitness facility
• Employee Assistance Program
• disability coverage
• stocked kitchen
• professional development and mentorship.

Why this role

Requires a related bachelor's degree and 5+ years of compliance experience in a regulated industry, such as pharmaceutical, biotech, or biologics GMP manufacturing. CQA certification is preferred.

About the employer

Forge Biologics is hiring for this role. Industry: All Other Basic Organic Chemical Manufacturing. Sector: 32.