Do you pride yourself on your integrity? We do what’s right for employees, patients and partners, and so can you.

Oxford Biomedica’s Quality Assurance Analytics Manager is responsible for managing the Quality Assurance Analytics Team, who are responsible for supporting the Quality Control activities and testing laboratories (covering QC Raw Materials, QC Microbiology, QC Chemistry and Analytical Services, Analytical development & Process Research and Development) at Oxford Biomedica. The Quality Assurance Manager is responsible for supporting Quality Control activities, processes and procedures that supports product quality, patient safety and efficacy by driving business alignment to cGxP, Regulatory & Industry expectations.

This role will report directly to the Head of Quality. This position requires in-depth understanding of cGxP regulations and guidelines related to Analytical Methodologies, associated Test Equipment & Facilities and proven applications in an Analytical GxP environment. Experience with implementation and working with Laboratory Information Management Systems (LIMS) is preferable.

Your responsibilities in this role would be:

• Manage a team of QA staff to support GMP, GLP & GCP (Labs) operations and ensure timely delivery of quality documents for internal and external clients.
• Reviewing and approving documentation generated from the Laboratories, (typical examples listed below);
  • Laboratory Facility Qualification plans, protocols and reports
  • Laboratory Equipment Qualification plans, protocols and reports
  • CSV Validation plans, protocols and summary reports
  • Analytical Method Validation plans, protocols & reports
  • Routine Analytical testing documentation
  • Stability plans, protocols & reports.
  • Out of Expectation, Out of Trend & Out of Specification reports.
  • Laboratory Equipment Maintenance & Calibration Reports
  • Policies, SOPs, Logbooks & Training Modules
  • Trend Reports
  • Annual Product Reviews
  • Continuous Process Verification (CPV) data & reports
• Working closely with the laboratory groups (QC Raw Materials, QC Microbiology, QC Chemistry and Analytical Services, Analytical development, Process Research and Development) to ensure that QC requirements are included in the Analytical Development lifecycle, resulting in robust and fit for purpose analytical methods.
• Reviewing, approving & ensuring Change Controls, Deviations, Out of Trend and Out of Specification investigations, Corrective and Preventative actions and Quality Risk Assessments associated with area of responsibility are appropriately investigated, reviewed, mitigated and approved for closure.
• Lead and provide support with performing Quality Risk Management Assessments.
• Establish systems and processes within QC and wider analytical platform to ensure that QC procedures, systems, data and documentation follow cGxP, data integrity requirements and regulations.
• Representing Quality on Client facing New Product Introduction (NPI) projects and providing guidance of requirements & expectations in relation to analytical methods.
• Reviewing and approving analytical data and commentary generated for regulatory submissions, as required.
• Writing, Reviewing and approving Quality SOPs, Policies and Training Modules.
• Reviewing and approving laboratory related Policies, Standard Operating Procedures (SOPs), Forms, logbooks and Training Modules.
• Supporting the Batch Release process by reviewing and approving required analytical data and provided required documentation to the Qualified Persons (QP) Group.
• Responsible for leading & performing internal audits of GMP laboratory areas & external audits of contract test houses / facilities.
• Qualification of Laboratory Subcontractors / contract test houses
• Responsible for the timely conduct of all internal GLP and GCP (Labs) facility, process and study specific audits and external supplier audits.
• Act as QA representative during Regulatory Inspections and Client &/or Internal audits.
• Promote continuous improvement initiatives to enhance working practices and to mitigate quality risks.
• Supporting Quality based projects working as part of a multidisciplinary team as required.
• Develop, manage and lead the QA Analytics group and all aspects of the people process including hiring, on-boarding, mentoring, coaching, annual objective setting, performance management and employee development.
• Ensure teams KPI’s, plans, targets and objectives are effectively monitored and achieved such as RFT.
• Embrace and actively drive Practical Process Improvements by identifying opportunities to improve quality/compliance, and increase operational efficiency. Partner with key stakeholders to prioritize projects aligning with the quality goals and objectives
• Ensure self and teams work complies with GxP, Data Integrity & Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents.
• Maintain thorough understanding of regulatory requirements & guidance for Industry documents. Ensure all work within the Quality department and across the site laboratory areas complies with the above.
• Deliver effective leadership and communications in line with company rules, policies and procedures
• Identifies and leads continuous improvement initiatives (incl. removal of non-value add tasks/activities).
• Provide support for a wide variety of activities to ensure compliance with quality systems, procedures, policies to facilitate compliance with regulatory, customer / client and MA holder requirements.
• Interfaces with regulatory agencies as required, representing Oxford Biomedica to authorities and regulatory inspectorate bodies, in meetings, communications, and inspections
• Keep up with current compliance requirements and industry best practice through published information and papers, benchmarking, and attending industry and regulatory agency sponsored meetings and seminars
• Maintain a state of readiness for regulatory inspections and client audits
• Support and encourage a ‘Quality Culture’.
• Manage and deliver timely closure of analytical data packages and QMS records to support batch release and core KPIs.
• Establish & maintain effective communications with peers, clients and CMOs

To be successful in this role, you will have the following skills and experience:

• Bachelor’s Degree in biology, biochemistry, analytical chemistry or other science related field
• Experienced within a GxP Environment – Experience within Biologics and/or Cell/Gene Therapy / pharmaceutical manufacturing/ Laboratories desirable.
• Experience of Laboratory Management
• In depth knowledge of cGxP, EU & US FDA regulations and product lifecycle applicable to ATMPs, biologics, cell/gene therapy, or pharmaceuticals.
• Experience of sterility testing, media fills and fill / finish manufacturing desirable
• A strong understanding of and the ability to apply quality requirements, regulatory requirements and risk management to cell and gene therapy products appropriate to the stage of development.
• Knowledge and Experience of Laboratory Facility & Equipment Qualification requirements 
• Knowledge of Analytical procedures and Method validation requirements (and required data) to support the documentation of the identity, strength, quality, purity, safety and potency of vector / drug substances and vector / drug products.
• Knowledge and experience of requirements for developing and validating analytical methods (Non-compendial Analytical Procedures, Validation Characteristics and Compendial analytical procedures).
• Knowledge and experience of requirements for performing Deviation, OOT and OOS investigations.
• Knowledge and experience of setting up / managing stability studies and analysing stability data
• Experience with use of LIMS (Laboratory Information Management Systems) is desirable

• Knowledge and experience of Data Integrity and Computerised System Validation (CSV) requirements.

• Experience of leading and performing internal & external audits.

Do you want to feel inspired every day? We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you.

Collaborate. Contribute. Change lives

No agencies please

We are a pioneering gene therapy business, and our mission is delivering life changing gene therapies to patients. We work together, motivated to make a difference, and so can you.

We are pioneers; no one else does what we do.

Gene therapy is the treatment of disease by the delivery of therapeutic DNA into a patient’s cells. It is transforming medicine as we know it, long term and potentially curative treatments for a wide range of diseases are now possible.

We are at the forefront of this exciting area. We have a strong reputation in gene therapy, with world leading expertise in lentiviral vectors. We have a leading, integrated platform of exclusive technologies to design, develop and bioprocess unique gene based medicines, both in house and with partners.

We drive credible science to realise incredible results.

Whether you’re motivated by the discovery and development of product candidates within Research, or by cutting edge tools and technologies including AI and automation of our contract development and manufacturing organisation, we can offer you a career like no other. We are excited about our future. Join us and change lives.