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Quality Assurance Specialist

Quality Assurance Specialist

  • Raleigh-Durham, NC
  • Full Time
  • Mid-Level
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).

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) Specialist to be a key member of our Quality Operations team, as well as support the Quality Systems, Quality Control and Quality Compliance functions. 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 pharmaceutical industry is expected; experience in the development or commercialization of biologics and advanced therapies is a plus. Importantly, we seek an aspiring professional with potential and desire to grow within the company.

 

The successful candidate will be an integral member of a growing Quality team, and work closely with a cross-functional development team and external partners. Critical roles include ensuring compliance with regulatory requirements and company procedures and supporting the build-out of our regenerative medicine manufacturing facility. This critical role will report to Associate Director of Quality Operations within the Quality team and be instrumental to the growth and success of our department and company. We seek an individual that can complement and expand the strengths of our team. 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 support for the build out of the Enzyvant Regenerative Medicine Manufacturing facility, initially including asset enrollment in the CMMS system, approving SOPs and Master Batch Records, and providing oversight of Engineering Runs
  • Provide Quality and Compliance oversight for manufacturing of commercial and investigational products through Shop Floor presence, review and approve GMP documentation, including but not limited to Batch Records, Specifications, Standard Operating Procedures, Deviations, CAPAs and Change Controls.
  • Proactively assess and identify risk for mitigation and communication to stakeholders.
  • Advise and direct on the interpretation and implementation of regulations, guidelines, company procedures, and standards for the Enzyvant Quality Management System.
  • Ensure a state of inspection readiness at our internal manufacturing facility; provide Quality support and audit management during Agency inspections.
  • Support the Enzyvant Quality Management System, including but not limited to processes for Document Management, Deviations, CAPA, Change Control, Complaints, Management Review, Validation and Data Integrity.
  • This role will initially be weekdays (Monday to Friday) but will transition to alternating shifts that include weekends as we initiate commercial manufacturing (planned for 2024).

Qualifications

  • B.S. in chemistry, biological or pharmaceutical sciences, or related discipline
  • At least 3 years of experience in the biotech/pharmaceutical industry within research and development or commercial organizations.
  • Experience in a cGMP manufacturing environment, with strong working knowledge of FDA requirements and guidance documents.
  • Relevant experience and knowledge of manufacturing, batch record review, and/or analytical analyses for the biotech/pharmaceutical industry.
  • Integrity, entrepreneurial spirit, ownership mentality, and a commitment to excellence.
  • Strong organizational skills and ability to work on multiple projects with tight timelines and minimal oversight.

Contact us for more information