We’re Hiring! View Open Positions

Quality Assurance Validation Manager

Quality Assurance Validation Manager

  • Raleigh-Durham, NC
  • Full Time
  • Manager
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 m eaning, 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) Validation Manager to join our team and support our Quality Operations, 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, leading Quality oversight of the Validation Program while supporting the build-out of our regenerative medicine manufacturing facility. This critical role will report to the Associate Director of Quality Operations 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 validation expertise and support for the development or modification phases of the facility, utilities, equipment, computerized systems, and processes.
  • Review and approve validation documents (e.g., test plans, protocols, reports, Validation Project Plans, Qualification documentation etc.) and other related documents to ensure compliance to internal procedures and regulatory requirements.
  • Ensure that the information contained in the approved validation document(s) is understandable and defendable during inspections.
  • Evaluate and approve discrepancies related to validations to ensure proper documentation of the incidents and identification of corrective action(s).
  • Collaborate and participate in projects as the Quality Representative for commissioning and validation activities.
  • Provide Change Control and/or Deviation assessment and support in the review of risk assessment(s).
  • Support internal and external audits.
  • Manage supporting personnel as required.

Qualifications

  • B.S. / M.S. in chemistry, biological or pharmaceutical sciences, or related discipline
  • At least 5 years of experience in the biotech/pharmaceutical industry with responsibility for QA oversight of validation activities.
  • Experience in a cGMP manufacturing environment with strong working knowledge of FDA requirements and guidance documents related to validation. Experience in a clinical QA environment and knowledge of GLP and GCP regulations is a plus.
  • Experience preparing for and supporting inspections performed by FDA and other regulatory bodies.
  • 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