About The Role: We are currently seeking a
Compliance Specialist Lead, to join the Forge Biologics team. This position will drive both the strategy and the delivery for Regulatory and Quality Compliance Initiatives, and this individual also oversees the GMP Internal Audit program. This person will support improvement initiatives related to the Quality Management Review (QMR), and support External Audit program, and processes to ensure Forge's compliance with the appropriate regulatory agency requirements, internal company standards, client requirements, and current Good Manufacturing Practices (cGMPs).
Responsibilities: - Ownership of the Internal Audit process, planning, execution and verification of actions.
- Support Regulatory Compliance/Quality Representatives and apply regulatory knowledge and judgment to identify potential compliance concerns and identify potential remediation action.
- Track corrective actions as a result of audit observations and obtains and reviews objective evidence as actions are completed in accordance with prescribed commitments.
- Support and update Site Governance and Standard Operating Procedures, Training and content/delivery. Promote audit/ inspection ready culture.
- Support the coordination of Management Review includes monitoring the overall health of the Quality system through evaluation of KPIs, effectiveness checks, and risk management.
- Partner with internal departments (e.g. Manufacturing, Quality, Facilities and Engineering) to ensure end-to-end compliance throughout the product lifecycle and commercial readiness.
- Exemplifies good quality and compliance practices while championing Quality Culture throughout the organization.
Qualifications: - Bachelor's degree in related discipline with 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, and where appropriate, other regulatory authority standards.
- Partner with internal departments (e.g. Manufacturing, Quality, Facilities and Engineering) to ensure end-to-end compliance throughout the product lifecycle and commercial readiness.
- Exemplifies good quality and compliance practices while championing Quality Culture throughout the organization.
Preferred Skills: - American Society for Quality- CQA or equivalent certification
- Project or Program Management experience a plus
Work Environment and Physical Demands Primarily office-based with extended computer use. Regular interaction with internal teams and external stakeholders. When on-site, adherence to safety requirements and use of PPE may be necessary.
Position requires prolonged sitting, reviewing detailed documentation, occasional standing/walking during site audits, and the ability to lift up to 15 pounds (e.g., files or laptop equipment).
We've Got You Covered: At Forge Biologics, we believe our people deserve to be taken care of - in and out of the workplace. We've built a comprehensive compensation and benefits package designed to help you thrive, grow, and feel valued every step of the way:
Health from day one- Health, dental and vision insurance start your first day - with 90% of premiums covered for you and your family.
Time to recharge- A competitive paid time off plan - because rest fuels innovation.
- 12 weeks of fully paid parental leave so you can focus on family when it matters most.
Rewarding your impact- Annual bonus opportunities for all full-time team members.
- 401(k) with company match to help you plan for the future.
- Special employee discounts, including childcare and dependent care savings.
Your wellness, supported- Onsite fitness facility at The Hearth.
- Mental health counseling and financial planning services through our Employee Assistance Program.
- Employer-paid short and long-term disability coverage to protect your peace of mind.
Fuel for your workday- A fully stocked kitchen with free snacks and beverages - we keep you energized and ready for what's next.
Grow with us- Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.
