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We offer a fantastic range of benefits including a highly competitive annual leave entitlement (with the ability to purchase more), a generous pensions scheme, flexible working opportunities, a commitment to your development and wellbeing, a wide range of retail discounts, and much more. Find out more about our benefits (opens in a new window) and join us to become part of something special.

Overview

The Quality Assurance (QA) Specialist will play a key role in supporting the QA team to ensure compliance with regulatory requirements related to the manufacture of gene therapies at the GTIMC facility. This position will contribute to maintaining MHRA inspection readiness and, once licensed, will support ongoing compliance to ensure the highest standards of product quality and patient safety.

Led by Professor Mimoun Azzouz, The GTIMC at Sheffield is dedicated to advancing the clinical development of new genetic treatments options for millions of patients with life-threatening diseases. The centre includes a purpose built GMP (good manufacturing practice) facility that will support gene therapy projects emerging from universities across the UK, helping novel medicines progress to clinical trials. The facility will utilise highly efficient processes to manufacture clinical grade adeno-associated viruses (AAV) and provide all the necessary quality assurance and regulatory certification for human trials at NHS hospital sites.

Located at the University of Sheffield’s Innovation District, the GTIMC is close to the centres of Sheffield and Rotherham and within easy reach of major transportation corridors and regional shopping and entertainment complexes.

­­­Main duties and responsibilities

• Assist in the development, implementation, and maintenance of quality systems, including document control, change control, deviation management, and risk assessment.
• Coordinate with cross-functional teams to ensure compliance with applicable regulatory guidelines, including but not limited to GMP, GLP, and other relevant quality standards.
• Collaborate with manufacturing and analytical teams to investigate and resolve product-related quality issues.
• Develop and implement corrective and preventive actions (CAPAs) to address identified non-compliance issues.
• Assist in the creation, review, approval, and maintenance of Standard Operating Procedures (SOPs), batch records, validation protocols, and other quality documentation.
• Assist and conduct internal audits and inspections to verify compliance with regulatory requirements and internal quality procedures.
• Ensure that all documentation is accurate, up-to-date, and readily accessible to relevant personnel.
• Support the investigation and resolution of customer complaints, deviations, and out-of-specification results.
• Identify opportunities for QA process improvement and collaborate with relevant stakeholders to implement quality enhancements.
• Participate in quality-related projects, including validation studies, process improvements, and risk assessments.
• To work as part of the wider GTIMC team, providing support as required to the other teams across the GTIMC facility as we work towards MHRA licensing.
• Understand cleanrooms and their associated regulation and regulators. 
• Undertaking other tasks relating to the GTIMC as requested by the post’s line manager.
• As a member of staff, you will be encouraged to make ethical decisions in your role, embedding the University sustainability strategy into your working activities wherever possible.
• Carry out other duties, commensurate with the grade and remit of the post

Further information

Grade: 6

Salary: £32,080 - £36,636 per annum. Potential to progress to £39,906 per annum through sustained exceptional contribution. 

Work arrangement: Full-time

Duration: Fixed Term Contract for 3 years. 

Line Manager: Head of Quality

Direct Reports: Head of Quality

Our website: https://www.sheffield.ac.uk/gtimc

This role is laboratory based on site at the Gene Therapy Innovation and Manufacturing Centre GTIMC, Sheffield Business Park, S9 1ZA. 

For informal enquiries about this job contact and for administration queries and details on the application process, contact the lead recruiter: Mike Reid on gtimc@sheffield.ac.uk or on 0114 222 0654.

Person specification

Our diverse community of staff and students recognises the unique abilities, backgrounds, and beliefs of all. We foster a culture where everyone feels they belong and is respected. Even if your past experience doesn't match perfectly with this role's criteria, your contribution is valuable, and we encourage you to apply. Please ensure that you reference the application criteria in the application statement when you apply.

Essential Critieria

• Bachelor's degree in a scientific discipline (e.g., Biology, Chemistry, Pharmacy, or related field). Advanced degree is a plus. Relevant work experience in and manufacturing capacity within gene therapy, biotechnology or other biological sciences.
• Proven ability to deliver in a role in a GMP Licenced manufacturing facility, preferably in gene therapy or advanced therapy medicinal products (ATMPs).
• Working knowledge of regulatory requirements (MHRA) and quality standards (e.g., GMP, GDP and GLP).
• Experience with electronic quality systems (such as QPulse), document control, deviation management, change control and CAPA processes.
• Excellent attention to detail, problem-solving skills, and the ability to work effectively in a team-based environment.
• Deal with queries that require Quality Assurance input to provide immediate support and problem resolution and escalate where required
• Experience of liaising with Manufacturing teams or Quality Control teams on one or more of the following activities; Batch record or test method review, technology transfer or validation.
• The ability to strictly adhere to written testing procedures, but also to think critically and propose changes to them where necessary.

Desirable Criteria

• Experience in the oversight of Environmental Monitoring programs
• Working knowledge of AAV manufacturing processes and release testing requirements

Next steps in the recruitment process

It is anticipated that the selection process will take place on Friday 3rd October. This will consist of an interview and a practical assessment. We plan to let candidates know if they have progressed to the selection stage on the week commencing 29th September. Contact Laura Haslam (l.haslam@sheffield.ac.uk) if you require any reasonable adjustments.

Our vision and strategic plan

We are the University of Sheffield. This is our vision: sheffield.ac.uk/vision.

What we offer

• A minimum of 38 days annual leave including bank holiday and closure days (pro rata) with the ability to purchase more.
• Generous pension scheme.
• A wide range of discounts and rewards on shopping, eating out and travel.
• A variety of staff networks, providing opportunities for social interaction, peer support and personal development (for example, Race Equality, LGBT+, Women’s and Parent’s networks).
• Recognition Awards to reward staff who go above and beyond in their role.
• A commitment to your development access to learning and mentoring schemes; integrated with our Academic Career Pathways and Professional Services Shared Skills Framework.
• A range of generous family-friendly policies
• paid time off for parenting and caring emergencies
• support for those going through the menopause
• paid time off and support for fertility treatment and more

More details can be found on our benefits page: sheffield.ac.uk/jobs/benefits. 

We are a Disability Confident Employer. If you have a disability and meet the essential criteria you will be invited to interview.  

Located at the University of Sheffield’s Innovation District, the GTIMC is close to the centres of Sheffield and Rotherham and within easy reach of major transportation corridors and regional shopping and entertainment complexes.

We are a research university with a global reputation for excellence. Our ideas and expertise change the world for the better, making a real difference to society. We know that when people come together with different views, approaches and insights it can lead to richer, more creative and innovative teaching and research and the highest levels of student experience. Our University Vision (www.sheffield.ac.uk/vision) outlines our commitment to building a diverse community of staff and students that recognises and values the abilities, backgrounds, beliefs and ways of living for everyone.