Spur Therapeutics
Director, Quality Assurance
Get notified of more jobs like this · No spam, ever
How your CV stacks up
Upload your CV to see how well it fits this job role
?%
No Agencies Please
We are handling the hiring internally. We do not accept unsolicited resumes from third-party recruiters or staffing agencies. Thank you.
Why Spur?
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.
What We Are Trying To Accomplish
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.
How Will We Do It
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.
Role Purpose
The Director, Quality Assurance is responsible for leading the Quality Assurance organization and providing strategic and operational oversight of the company’s GxP Quality activities. The Director will ensure that appropriate Quality systems, processes, and controls are established and maintained to support clinical development, regulatory submissions, product approval, and commercialization.
This position is responsible for maintaining a state of inspection readiness and ensuring compliance with applicable FDA, European Union, and other relevant global regulatory requirements. The Director will play a key role in preparing for and supporting regulatory authority inspections, including FDA Pre-Approval Inspections (PAIs) and applicable EU regulatory inspections.
The successful candidate will demonstrate strong Quality judgment and the ability to distinguish between routine operational issues and matters representing significant product, patient, regulatory, or compliance risk.
The Director must be capable of operating both strategically and tactically. In a lean organization, the individual will be expected to establish Quality strategy and governance while remaining sufficiently engaged in operational activities to understand issues, challenge investigations and decisions, and provide effective leadership during critical manufacturing, analytical, regulatory, and inspection-readiness activities.
Reasons to use Rodeo
Start with a chat, not a search bar
Grad scheme, placement, apprenticeship? Not sure what you want yet — that's fine. Your agent talks it through with you and turns "I have no idea" into a shortlist.
It searches the market for you
Every day your agent scans the market matching roles against what actually matters to you, not just keywords on a CV.
Only hits
No noise. No "maybe this fits." Just roles with a clear explanation of why they're right — and where to focus when applying.
The successful candidate will have significant experience within pharmaceutical, biotechnology, biologics, cell therapy, and/or gene therapy organizations and demonstrated experience leading Quality activities in an outsourced manufacturing and testing environment. Experience supporting product approval and commercial launch is highly desirable.
The Director, Quality Assurance reports to the Chief Technical Operations Officer (CTOO).
Role and Responsibilities
- Provide leadership and direction for the Quality Assurance organization
- Establish Quality priorities, objectives, and operating expectations aligned with company development, regulatory, and commercialization objectives.
- Ensure clear roles, responsibilities, and decision-making authority across the Quality organization.
- Provide Quality leadership and guidance to Technical Operations, Manufacturing, Analytical, Supply Chain, Regulatory, Clinical, and other GxP functions.
- Serve as senior Quality representative on cross-functional governance teams and operational forums.
- Identify emerging Quality and compliance risks and ensure appropriate mitigation and escalation.
- Develop and maintain Quality metrics and periodically communicate Quality System performance, compliance risks, and significant issues to executive leadership.
- Promote a strong Quality culture emphasizing patient safety, product quality, data integrity, regulatory compliance, and continuous improvement.
- Develop and execute inspection readiness assessments, mock inspections, and remediation plans.
- Ensure personnel are appropriately trained for inspection participation and interactions with regulatory authorities.
- Establish inspection management procedures, including front-room and back-room operations, document request management, SME preparation, response development, and inspection logistics.
- Serve in a leadership role during regulatory authority inspections.
- Coordinate development, review, and timely delivery of responses to regulatory inspection observations and commitments.
- Partner with Regulatory Affairs, Technical Operations, Manufacturing, Analytical, and Supply Chain functions to ensure Quality readiness for regulatory submissions and product approval.
- Provide Quality support for preparation and review of relevant CMC and Quality sections of regulatory submissions.
- Provide Quality oversight of PPQ, validation, stability, and other activities supporting regulatory approval.
- Assess Quality organizational capabilities and identify additional systems, processes, resources, and infrastructure required for commercialization.
- Support development of commercial Quality processes, including Continued Process Verification, Product Quality Review, complaint management, change management, and post-approval regulatory commitments.
Get help with your application
Your very own career expert that helps elevate your application to the next level.
- Lead, develop, and mentor Quality Assurance personnel
- Establish individual and functional objectives aligned with company Quality and business priorities.
- Develop technical and leadership capabilities within the Quality organization.
Qualification, Education and Experience Requirements
- Bachelor’s degree in biology, chemistry, biochemistry, engineering, pharmaceutical sciences, or another relevant scientific discipline is required.
- An advanced scientific, engineering, or business degree is preferred.
- Minimum of 12 years of progressively responsible Quality Assurance experience within the pharmaceutical, biotechnology, biologics, cell therapy, and/or gene therapy industry.
- Demonstrated experience leading Quality functions and personnel within a GxP-regulated organization.
- Significant experience with pharmaceutical Quality Systems and cGMP requirements.
- Demonstrated experience preparing for and supporting FDA regulatory inspections.
- Experience with regulatory inspection readiness programs, mock inspections, inspection management, and regulatory authority responses.
- Experience providing Quality oversight of external CDMOs, contract testing laboratories, and other GxP service providers.
- Experience with manufacturing investigations, deviations, CAPAs, change controls, and batch disposition.
- Experience with analytical Quality oversight, including laboratory investigations and data integrity.
- Experience supporting process validation and PPQ activities.
- Experience working with electronic Quality Management Systems.
- Experience with biologics, viral vectors, AAV, cell therapy, gene therapy, or other advanced therapy products is highly desirable.
- Comprehensive knowledge of FDA cGMP regulations, including applicable requirements under 21 CFR Parts 210 and 211.
- Strong working knowledge of relevant EU GMP requirements and expectations.
- Strong understanding of contemporary pharmaceutical Quality Systems and relevant ICH guidance, including ICH Q7, Q8, Q9, Q10, and Q12, as applicable.
- Understanding of EU GMP Annex 1 requirements applicable to sterile medicinal products.
- Strong knowledge of Quality risk management, investigation, root cause analysis, CAPA, change control, and supplier Quality principles.
- Strong understanding of data integrity and Good Documentation Practices.
- Ability to evaluate complex Quality and compliance issues and make risk-based decisions.
- Ability to effectively interact with regulatory inspectors and senior representatives of external manufacturing and testing organizations.
- Strong written and verbal communication skills, including the ability to communicate significant Quality risks to executive leadership.
- Demonstrated ability to lead cross-functional teams through complex Quality, compliance, and operational issues.
- Ability to balance regulatory compliance, patient safety, product quality, operational requirements, and business objectives.
“It took my CV and asked me questions relevant to understanding what kind of jobs to suggest for me. Suggestions were almost perfect. Jobs were exactly what I’ve been looking for.”
Jessica, London