Location: Raleigh-Durham, NC
Who We Are
Enzyvant is a commercial-stage biotechnology company on the leading edge of regenerative medicine for rare diseases. Our lead asset is FDA-approved RETHYMIC®, a tissue-based regenerative therapy for an ultra-rare and life-threatening pediatric immunodeficiency. It is an exciting time for the Enzyvant team as we deliver on our patient purpose and execute on our bold vision for growth.
Patients are the heart and soul of Enzyvant, inspiring deep meaning, passion, and purpose in our work. They are all the reasons for why, how, and what we do. At Enzyvant, we see a world where the promise of our breakthrough biotechnologies is fully realized to transform the lives of patients battling devastating rare diseases. To achieve this vision, we are pursuing new uses and geographies for our biotechnologies and providing extensive support to help families navigate the complexity of rare diseases with our Enzyvant Connect program.
The Enzyvant team includes some of the most innovative talent in the regenerative medicine sector today. We attract people in biotech who want to make their mark in regenerative medicine and deliver truly meaningful, life-changing solutions for patients. Our company culture values teamwork, innovation, empowerment, and integrity. Enzyvant has a small company feel with the reach and resources of our global parent company Sumitovant Biopharma Ltd. (wholly owned by Sumitomo Pharma).
The Quality team at Enzyvant takes pride in leading compliant and innovative approaches to the development and commercialization of life-saving therapies. Enzyvant is building a regenerative medicine manufacturing facility in Morrisville, NC to support both commercial and research needs, and the Quality team is growing significantly.
We are looking for an Associate Director of Quality Systems to join our team and lead the Quality function responsible for the build-out of our Quality systems in support of Enzyvant’s new commercial manufacturing facility and clinical operations. The successful candidate will be highly motivated and skilled with automated systems knowledge and be able to function in a fast-paced fluid environment. Enzyvant seeks a candidate who will be dedicated to excellence and high performance, passionate, innovative, and eager to work in a collaborative environment with a demonstrated track record of success in the biopharmaceutical industry while having experience in developing, implementing, and maintaining Quality Systems; experience with implementing Quality systems in support of manufacturing biological or advanced therapies is a plus. Moreover, we seek an aspiring professional with potential and desire to grow within the Company.
The successful candidate will report to the Senior Director of Quality, be an integral leader of a growing Quality team, and work closely with a cross-functional development team and external partners. Given the small company and dynamic nature of the work, the successful candidate must take an entrepreneurial approach, be agile and have strong interpersonal skills.
- Management, maintenance, execution, compliance and continuous improvement of Enzyvant’s Quality Systems as system owner/facilitator in support of QA operations.
- Business Administrator and Subject Matter Expert for Enzyvant’s eQMS.
- Manage all aspects of document control, including but not limited to administering automated systems and overseeing paper-based processes.
- Develop, refine, and monitor metrics to assess our quality system and ensure that the QMS meets or exceeds the requirements of GXP and applicable industry standards.
- Prepare Quality Systems performance metrics for management review.
- Manage and contribute to continuous improvements for the Enzyvant QMS, including but not limited to processes for Document Management, Training, Supplier Management, Audits and Inspections, Deviations, CAPA, Change Control, and Product Complaints.
- Maintain a state of QMS inspection readiness and provide support during Agency inspections.
- B.S. / M.S. in chemistry, biological or pharmaceutical sciences, or related discipline with at least 3-5 years of Quality Systems experience and 7+ years related automated systems experience.
- Prior experience interfacing with the FDA and other regulatory bodies.
- Working knowledge of GMP regulations and FDA requirements, Guidance documents, and industry best practices.
- Knowledge of current best practices and industry standards for biotechnology / pharmaceutical company Quality systems. Experience with implementing systems to support new facilities and/or laboratories preferred.
Enzyvant is committed to maintaining a safe and productive workplace and work experience for our team members. As part of these ongoing efforts, Enzyvant requires all employees to be fully vaccinated against COVID-19, and this position requires that you be fully vaccinated against COVID-19 prior to your start date, as a condition of employment. If you are unable to be vaccinated, we will consider requests for reasonable accommodations in accordance with applicable legal requirements.