Compliance Specialist Lead

About the Role: 

This position will drive both the strategy and the delivery for Regulatory and Quality Compliance Initiatives, with primary responsibility in overseeing the GMP Internal Audits program. In addition, this individual will support improvement initiatives related to the Quality Management Review (QMR),  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). 

 

What You'll Do:

• 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.

What You'll Bring:

• 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. 

Preferred Skills:

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

This position works in a typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. This is largely a sedentary role; persons holding office positions are generally subject to inside environmental conditions having the lighting, temperature, and noise of an open floor-plan office environment. Regularly operate a computer and other office equipment. Regularly communicate with others in person, over the phone, and electronically. Must be able to move and/or carry objects weighing up to 10 lbs. 

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned. 

 

Life at Forge  

We are a team of diverse, driven and passionate people working together to trailblaze a new model for how we make medicines to treat patients with genetic diseases. Our team members use their creativity and talent to invent new solutions, meet new demands, and offer the most effective services in the industry. Forge’s core values lay the foundation for H.O.P.E. It provides us a common purpose that we all understand, work towards and live by.  

 

HARDWORKING - We work hard and smart, making a persistent and determined effort toward success. Working hard, with focus and desire is the key. 

OPEN - We strive to be approachable, actively listen and encourage others to contribute and speak up. We positively offer and receive constructive feedback. 

PURPOSE DRIVEN - We are passionate about working towards and delivering on our mission to manufacture gene therapies. 

ENGAGED - We are fully absorbed by and enthusiastic about our work and take positive action to further Forge’s vision, mission and goals. 

 

We’ve Got You Covered 

We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly UnFORGEttable. 

Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents 

Competitive paid time off plan 

Annual bonus for all full-time employees 

401(K) company match 

Fully-stocked kitchen with free food/drinks 

12 weeks of paid parental leave - additional discount programs include childcare support & dependent care 

Employee Assistance Program  

Wellness benefits (financial planning services, mental health counseling, employer paid disability) 

Onsite fitness facility  

Professional & Personal development resources