Quality Assurance Specialist - Quality Systems

No Agencies Please:
We are handling the hiring internally. We do not accept unsolicited resumes from third-party recruiters or staffing agencies. Thank you.

Gene therapy is at an inflection point. Amidst the noise of countless emerging modalities, we've been hard at work refining our science and advancing our programs with quiet determination and a bold ambition to unlock the true potential of gene therapy to change the trajectory of more patients' lives. Come join Spur's dedicated team of scientists, physicians and other professionals who are singularly focused on using cutting-edge science and technology to transform the treatment of serious and debilitating chronic diseases.

We are a clinical-stage biotech company developing transformative adeno-associated virus (AAV) vector-mediated gene therapies. Founded in 2015, Spur is focused on developing innovative, one-time treatments that set new standards of care by optimizing every component of our product candidates to develop first- and best-in-class gene therapies. We are currently advancing a highly differentiated gene therapy candidate into a Phase 3 clinical trial in people with Gaucher disease and a preclinical gene therapy program for Parkinson’s disease.

Spur is global, with offices in Stevenage, UK, as well as operations in Boston and New York.

We are relentless in our pursuit of transformative medicines for patients. We take innovation seriously and know we need to be bold both in our science and in every aspect of our work. We also know we can only achieve these things together, so we act as one Spur and expect that of each colleague in the company. We always do the right thing - the trust of patients and their caregivers is critical to our success.

If you have an entrepreneurial mindset, are willing to work hard to transform the lives of patients, and share our values, then Spur could be the place for you.

The Quality Assurance Specialist
- Quality Systems is responsible for supporting, administering, and continuously improving the company’s Quality Management System (QMS) to ensure compliance with applicable regulatory requirements, industry standards, and company procedures.

This position will have a significant role in the day-to-day management of the electronic Quality Management System (eQMS), including document control, training, deviations, CAPAs, change controls, investigations, supplier quality, and other quality system processes. The individual will work cross-functionally with Quality, Technical Operations, Analytical, Supply Chain, Clinical, Regulatory, and external contract organizations.

The successful candidate will bring at least five years of Quality Assurance and Quality Systems experience within the pharmaceutical, biotechnology, biologics, cell therapy, and/or gene therapy industry and will be comfortable operating in a dynamic environment where responsibilities may span multiple quality system areas.

The Quality Assurance Specialist
- Quality Systems will report to the Head of Quality or other designated Quality leader.

• Support the administration, maintenance, and continuous improvement of the company Quality Management System.
• Serve as a key administrator and subject matter resource for the electronic Quality Management System (eQMS).
• Support configuration, implementation, maintenance, and optimization of eQMS workflows and processes.
• Monitor quality system activities to ensure records are initiated, investigated, reviewed, approved, and closed within established timelines.
• Maintain Quality System metrics and identify trends, recurring issues, and opportunities for improvement.
• Support periodic Quality Management…