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Senior Manager, Quality Systems and Compliance

Senior Manager, Quality Systems and Compliance

  • Raleigh-Durham, NC
  • Full Time
  • Senior Manager

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 Senior Manager of Quality Systems and Compliance to join our team and lead Quality function responsibilities related to our Quality Management System and internal as well as external (ie, suppliers, vendors, and CMOs) compliance. The ideal candidate will be dedicated to excellence and high performance, passionate, innovative, and eager to work in a collaborative environment. 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

  • Own and maintain a robust vendor management program, including Quality Agreements, an auditing program, and CAPA system for audit findings or vendor quality issues.
  • Perform, document, and manage vendor qualification, vendor audits and vendor scorecards, leveraging external consultants for support as appropriate.
  • Plan, perform, document, and manage internal audits.
  • Assist in batch release for product manufactured by a CDMO or the Enzyvant Manufacturing Facility as needed.
  • Advise and direct on the interpretation and implementation of regulations, guidelines, company procedures, and standards.
  • Contribute to improvement of the company Quality Management System; work collaboratively and cross functionally to ensure the QMS is maintained in a state of control.
  • Prepare and share information within subject matter expertise for Senior Leadership.
  • Support maintaining a state of inspection readiness; provide leadership and support during Agency inspections.

Qualifications

  • B.S. / M.S. in chemistry, biological or pharmaceutical sciences, or related discipline with at least 5 years experience in the biotech/pharmaceutical industry.
  • Demonstrated growth and responsibility in management and leadership.
  • Experience working with suppliers and 3rd party contract organizations.
  • Proficiency leading internal and vendor audits; audit credentials or certification preferred.
  • Strong working knowledge of GMP regulations and standards including USP / Ph. Eur, GMP, FDA/EMA, and ICH. Experience with GLP and GCP regulations preferred.
  • Significant work experience in a cGMP manufacturing environment, with strong working knowledge of FDA requirements, Guidance documents, and industry best practices.
  • Experience with biologics, advanced biologic therapies, and/or aseptic techniques preferred.
  • Strong organizational skills and ability to work on multiple projects with tight timelines and minimal oversight.

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