Compliance Specialist Lead

The role

This person will drive strategy and delivery for Regulatory and Quality Compliance Initiatives and oversee the GMP Internal Audit program. They will support improvement initiatives for Quality Management Review and the External Audit program to ensure compliance with regulatory requirements and cGMPs.

What you will do

• Ownership of the Internal Audit process, planning, execution and verification of actions.
• Support Regulatory Compliance/Quality Representatives and apply regulatory knowledge to identify potential compliance concerns and remediation action.
• Track corrective actions as a result of audit observations.
• Support and update Site Governance and Standard Operating Procedures, Training and content/delivery.
• Support the coordination of Management Review including monitoring the overall health of the Quality system.
• Partner with internal departments to ensure end-to-end compliance throughout the product lifecycle.
• Exemplify good quality and compliance practices while championing Quality Culture.

Required qualifications

• Bachelor’s degree in related discipline
• 5+ years of compliance experience in a regulated industry (i.e., regulatory compliance experience in a pharmaceutical, biotech, or biologics GMP regulated manufacturing environment)
• Excellent analytical, communication, and problem solving skills
• Proven ability to manage multiple prior in a fast- paced environment
• Experience interacting with domestic and international regulatory agencies
• Working knowledge of quality systems and ability to apply GMP’s in conformance to U.S. and Global standards
• Prolonged sitting
• Reviewing detailed documentation
• Occasional standing/walking during site audits
• Ability to lift up to 15 pounds

Nice to have

• American Society for Quality - CQA or equivalent certification
• Project or Program Management experience

Benefits

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

About the company

Forge Biologics aims to enable access to life-changing gene therapies. The team works out of The Hearth, a 200,000-square-foot cGMP facility in Columbus, Ohio.