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Director, Quality & Regulatory Compliance

Forge Biologics

Forge Biologics

Legal, Quality Assurance
Columbus, OH, USA
Posted on Tuesday, June 18, 2024

About Forge

Our mission at Forge Biologics, is to enable access to life changing gene therapies and help bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most.

Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services.

About The Team

The Regulatory Affairs department plays a critical role in ensuring that our products meet regulatory standards and compliance requirements to deliver safe and effective gene therapy solutions to patients. As a central hub for regulatory activities, our department is comprised of cross-functional teams, which include Quality Management, Quality Control, IT, and Compliance. Together, these departments collaborate closely to navigate the complex regulatory landscape, drive continuous improvement, and uphold the highest standards of quality and compliance in support of our mission to enable access to life changing gene therapy solutions for our patients.

About The Role

We are currently seeking a Director of Quality & Regulatory Compliance (position title to be determined based upon experience)to join the Forge Biologics team. This is an exciting opportunity to contribute to the manufacture of life changing gene therapies for human use. The ideal candidate will be highly organized, experienced in project management, and have a keen attention to detail to contribute to the management of the quality system. The Regulatory Compliance Director provides strategic leadership for quality culture, inspection readiness, clinical to commercial transition, and escalation process for the CDMO business unit. The role has specific focus on external and internal manufacturing/testing inspection readiness and ongoing compliance to changing regulatory expectations.

Regulatory Compliance is responsible for supporting regulatory agency and client responses following receipt of formal observation(s). Regulatory Compliance will act as a champion for compliance with process design controls, good documentation practices, and risk management standards. The individual is responsible for reviewing documents carefully to ensure that all requirements are clearly identified and required testing and/or manufacturing activities are planned to support needed regulatory and client compliance objectives.

Regulatory Compliance, as a function of Regulatory Affairs, drives the strategy and the delivery for Quality Management Reviews (QMR) and the Internal Audit (IA) program, and will develop and lead Annual Product Reviews (APR). This person will lead and drive all improvement initiatives related to the QMR, APR, and IA programs and processes to ensure Forge’s compliance with the appropriate regulatory agency requirements, internal company standards, client requirements, and current Good Manufacturing Practices (cGMPs) as a commercial supplier.

What You'll Do

  • 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.

What You'll Bring

  • 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.

Preferred Skills

  • Experience with aseptic processing.
  • Experience in interactions with domestic and international regulatory agencies.

Work Environment and Physical Demands

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.

Travel on an infrequent basis is required (0 to 5%) to support job responsibilities and commitments.

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
  • 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