Director, Regulatory Compliance
Forge Biologics
- Columbus, OH
- Permanent
- Full-time
- Leads as a Regulatory Compliance/Quality Representative for later phase and commercial manufacturing operations.
- Monitor and interpret cGMP regulatory guidelines and trends in the breakthrough therapy regulatory space and incorporate into inspection readiness and control strategies.
- Applies regulatory knowledge and judgment to identify potential compliance concerns and identifies potential remediation action.
- Serves as a liaison with internal departments and external consultants and CROs associated with all quality improvement initiatives.
- Oversees a team ensuring the timely delivery of Annual Product Reviews and Product Quality trending for all products.
- Oversees a team responsible for the Internal Audit process, including the Standard Operating Procedures, EQMS (i.e., Veeva) workflow, and training content/delivery. This also includes monitoring the overall health of the system through evaluation of KPIs and periodic effectiveness checks.
- Stays abreast of the facility's open CAPAs, ongoing audits, and general regulatory agency and client inspection preparedness.
- Oversees a team responsible for Management Review, which keeps facility staff informed of changes in regulations or international standards that may affect products.
- Provides support to the Quality Assurance team in the investigation and resolution of CAPAs.
- Leads regulatory agency and client interactions/audits and responses following receipt of formal observation(s).
- Oversees the corrective action activities for internal and external audit observations and obtains and reviews objective evidence as actions are completed in accordance with prescribed commitments.
- Gathers metric information for use in continuous improvement of areas of responsibility. Reports to management as needed.
- Performs other duties as required.
- Director level: Bachelor's degree in Biology or Science related discipline with 6+ years of compliance experience in a regulated industry (i.e., regulatory compliance experience in a pharmaceutical, biotech, or biologics GMP regulated manufacturing environment).
- Experience within a pharmaceutical, biotech, or related industry with a preference toward direct CGT industry experience.
- Expert knowledge of quality systems and ability to apply GMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards, especially those governing Cell and Gene Therapy (CGT) products.
- Experience in the application of global cGMPs.
- Experience in interactions with clients.
- Ability to communicate with respect to technical issues, both verbally and in written form.
- Expert interpersonal, verbal, and written communication skills, including strong presentation skills and ability to influence others.
- Experience with CAPAs and audit practices and strategies.
- Excellent organizational skills, attention to detail, and Good Documentation Practices.
- Strong proficiency in MS Word, Excel, Power Point, and other applications.
- Ability to communicate and work independently with scientific and/or technical personnel.
- Comfortable in a fast-paced, patient-focused manufacturing environment with minimal direction and able to adjust workload based on changing priorities.
- Ability to work hours necessary to support audits and/or inspection readiness activities.
- Ability to present to and interact with Senior Management and/or Leadership.
- Experience with aseptic processing.
- Experience in interactions with domestic and international regulatory agencies.
- 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
- Flexible PTO (plus 14 paid company holidays)
- 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)
- Professional & Personal development resources - LinkedIn Learning, a dedicate training staff in-house, mentoring opportunities & access to leadership development coaches