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Associate Director, Quality Assurance

Associate Director, Quality Assurance

  • Raleigh-Durham, NC
  • Full Time
  • Associate 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) Associate Director to join our team and lead the QA function responsible for oversight of our contract manufacturers as we establish our new commercial manufacturing facility, with the expectation that the role will evolve into a Quality leadership position within Enzyvant’s 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 leading 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

  • Ensure Quality and Compliance oversight for commercial manufacturing, supply chain, nonclinical and clinical manufacturing at Enzyvant’s contract manufacturers, including responsibility for disposition of batches.
  • Support the planning and execution for the build of the Enzyvant Regenerative Medicine Manufacturing facility, with longer-term responsibilities within the facility.
  • Provide guidance, support, training, and input on the interpretation and implementation of regulations, guidelines, company procedures, and standards.
  • Support a robust vendor management program.
  • Contribute to improvements in 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.
  • Approve GMP documentation, including but not limited to Specifications, Standard Operating Procedures, Validation Protocols and Reports, Deviations, CAPAs and Change Controls.
  • Manage direct and dotted line reports to efficiently manage Enzyvant CDMOs and improve the company Quality Management System; work collaboratively and cross functionally to ensure the QMS is maintained in a state of control.
  • Prepare and present Joint Quality Management Reviews (with CDMO partners).
  • Lead Enzyvant support for ensuring a state of inspection readiness at our contract manufacturers and provide leadership and audit management during Agency inspections.

Qualifications

  • B.S. / M.S. in chemistry, biological or pharmaceutical sciences, or related discipline
  • At least 3 years of managerial experience and 10 years of overall industry experience, including responsibility for Quality CMO oversight.
  • Significant work experience in a cGMP manufacturing environment, including management and leadership activity.
  • Prior experience interfacing with and managing inspections performed by FDA and other regulatory bodies.
  • Proficiency with GMP regulations; experience with GLP and GCP regulations preferred.
  • Strong working knowledge of FDA requirements, Guidance documents, and Industry Compendia.
  • 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