Compliance Specialist Lead

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). Work environment is primarily office-based with extended computer use and regular interaction with internal teams and external stakeholders. When on-site, adherence to safety requirements and use of PPE may be necessary.

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 obtain and review objective evidence as actions are completed in accordance with prescribed commitments; Support and update Site Governance and Standard Operating Procedures, Training and content/delivery, and promote audit/inspection ready culture; Support the coordination of Management Review, including 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; Exemplify good quality and compliance practices while championing Quality Culture throughout the organization

Requirements

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 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 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

Nice to have

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

Benefits

Health, dental and vision insurance from day one with 90% of premiums covered for 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; 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