GMP Compliance Lead — Quality & Audit Strategy

Forge Biologics; Columbus (OH); Sur place; USD 120 000 - 180 000; Plein temps

Avantages offerts par ce poste

Health insurance

401(k) with company match

Parental leave

Résumé du poste

Forge Biologics in Columbus, Ohio is seeking a Compliance Specialist Lead to drive regulatory and quality compliance initiatives and oversee GMP internal audits. You will own the internal audit process and coordinate management reviews to monitor KPIs and risk.

Bring strong analytical, communication, and problem-solving skills, with 5+ years in compliance in regulated environments, and the ability to engage with domestic and international regulatory agencies.

Qualifications

• Bachelor’s degree required with 5+ years of compliance experience in a regulated industry.
• Excellent analytical, communication, and problem solving skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Experience interacting with domestic and international regulatory agencies.
• Knowledge of GMPs and quality systems aligned to U.S. and global standards.

Responsabilités

• Own the Internal Audit process, planning, execution and verification of actions.
• Support Regulatory Compliance/Quality teams and apply regulatory judgment to identify remediation needs.
• Track corrective actions from audits and verify objective evidence.
• Update Site Governance, SOPs, training content and promote audit-ready culture.
• Coordinate Management Review to monitor KPIs, overall quality health and risk.
• Collaborate with Manufacturing, Quality, Facilities and Engineering for end-to-end compliance.
• Champion good quality and compliance practices across Forge.

Connaissances

Analytical

Communication

Problem Solving

Time Management

Regulatory Knowledge

Quality Systems

Formation

Bachelor’s degree in related discipline

Description du poste

Forge Biologics in Columbus, Ohio is seeking a Compliance Specialist Lead to drive regulatory and quality compliance initiatives and oversee GMP internal audits. You will own the internal audit process and coordinate management reviews to monitor KPIs and risk.

Bring strong analytical, communication, and problem-solving skills, with 5+ years in compliance in regulated environments, and the ability to engage with domestic and international regulatory agencies.