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Director, Quality Assurance

Director, Quality Assurance

  • Raleigh-Durham, NC
  • Full Time
  • Director

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).

Description

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 a Quality Assurance (QA) Director to join our team and lead the QA function for Internal Manufacturing at Enzyvant’s new commercial manufacturing facility. The ideal candidate will be dedicated to excellence and high performance, passionate, innovative, and eager to work in a collaborative environment. A demonstrated track record of success in the biopharmaceutical industry and experience directing QA activities for biological or sterile commercial products is expected; experience with advanced therapies is a plus. Importantly, we seek an aspiring professional with potential and desire to grow within the company.

 

The successful candidate will report to the Senior Director of Manufacturing 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 be agile and have strong interpersonal skills, with an ability to maintain focus on efficiently advancing innovative medicines addressing rare and often fatal diseases.

 

Responsibilities

  • Provide Quality leadership on planning and execution for the build of the Enzyvant Regenerative Medicine Manufacturing facility
  • Ensure and deliver Quality and Compliance oversight for manufacturing of commercial and investigational products, including disposition of batches manufactured by the Enzyvant Manufacturing Facility or a CDMO.
  • Provide guidance, support, training, and input on the interpretation and implementation of regulations, guidelines, company procedures, and standards to direct reports and cross-functional team.
  • Manage and contribute to continuous improvements for the Enzyvant Quality Management System, including but not limited to processes for Audits and Inspections, Document Management, Deviations, CAPA, Change Control, Complaints, Management Review, Validation and Data Integrity.
  • Manage direct and dotted line reports to monitor and improve the company Quality Management System and ensure compliant and efficient manufacturing; work collaboratively and cross functionally to ensure the QMS is maintained in a state of control.
  • Prepare and present internal Quality Management Review and Joint Quality Management Reviews (with CDMO partners).
  • Approve GMP documentation, including but not limited to Specifications, Standard Operating Procedures, Validation Protocols and Reports, Deviations, CAPAs and Change Controls.
  • Maintain a state of inspection readiness and provide leadership and audit management during Agency inspections.

Qualifications

  • B.S. / M.S. in chemistry, biological or pharmaceutical sciences, or related discipline with at least 5 years QA management experience and 10+ years related experience.
  • Demonstrated growth and responsibility in management and leadership, including significant work experience in a cGMP manufacturing environment.
  • Prior experience interfacing with and managing inspections performed by FDA and other regulatory bodies.
  • Expert level knowledge of GMP regulations and FDA requirements, Guidance documents, and industry best practices.
  • Strong working knowledge of Industry Compendia, regulations, and standards including USP / Ph. Eur, GMP, FDA/EMA, and ICH.
  • Knowledge of current best practices and industry standards for biologics manufacturing; experience with advanced biologic therapies and aseptic techniques 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.

Contact us for more information