Head of Quality

Overview

Job title: Head of Quality
Reporting to: Head of GMP
Department: GMP
No of Direct reports: 3+
Location: Bristol

eXmoor Pharma is the only integrated cell and gene therapy CDMO with over 20 years of consultancy expertise embedded across every stage of the CMC journey - from early-phase strategy to process development, GMP manufacturing and commercialisation. We provide comprehensive support across Viral Vectors, Autologous and Allogeneic Cell Therapies, and RNA technologies. This integrated model enables seamless progression from early-phase strategy through to commercial readiness.

Responsibilities

• The Head of Quality will be responsible for the ongoing management of the GMP Quality team and its continued expansion, and taking a lead role in establishing and operating the GMP PQS and Quality Control department.
• The Quality function oversees eXmoors PQS and ensures a Quality Culture is embedded into its GMP functions. The Quality team comprises two main functions, the QA team and the Analytical Services (AS) team, of which the QC function forms a part.
• Set the Quality Culture within GMP operations and report to senior leaders on compliance to Quality standards. Build and grow the Quality function to meet business needs.
• Help further establish and develop the GMP Quality team and be responsible for the day-to-day management, operation, scheduling and administration of the PQS and QC operations ensuring they are operated and maintained as required by the facility's licences.
• Work with a globally recognised team of scientists, consultants and engineers on a wide range of client projects while developing your quality management career.
• Take responsibility for the GMP manufacturing facility capable of handling a wide range of cell and gene therapies and small scale complex biologics.
• Lead the implementation of SOPs for all activities within ownership of QA and the AS laboratory function.
• Lead AS to ensure analytical results (GMP) are reviewed and approved at an appropriate level before submission to QA for review.
• Lead QA to ensure production/QC records are evaluated and signed by authorised personnel before they are sent to the Qualified Person (QP) for review.
• Manage systems that comprise the PQS including risk management, deviations, change control, self inspections/audits, complaints and recall, and OOS.
• Review and approve all operational SOPs prior to implementation.
• Complete routine quality reviews and approval of maintenance, calibration and validation activities, as required.
• Lead AS in the reporting on environmental monitoring trends.
• Communicate with Qualified Persons any issues impacting on QP responsibilities and batch certification.
• Collaborate with Head of Production to ensure IMPD requirements are translated into operational activities and specifications.
• Ensure the PQS is performing against set KPIs and communicate performance to senior leadership, escalating issues as required.
• Ensure all AS validations/qualifications are complete and up to date.
• Support the AS lead in ensuring the AS function can support both QC and AD functions; supervise the system for management of reference/retain samples of materials and products.
• Input into GMP technical transfer processes for AS.
• Develop, maintain and communicate product specifications and testing schedules in collaboration with Head of Production and eXmoor Procurement.
• Approve sampling plans and specifications.
• Host and support teams during regulatory and client audits.
• Ensure documentation across all GMP operations meets Data Integrity requirements and is maintained in line with licences.
• Manage all aspects of Quality planning including resource, budget, progress reporting and forecasting; coordinate with Production and Procurement to ensure procurement and storage of key supplies.
• Monitor GMP compliance within Quality; participate in management reviews of process performance and product quality; advocate continuous improvement; escalate quality issues quickly and effectively.

Person Specification

Essential Qualifications & Experience:

• Postgraduate degree level in an appropriate subject area - MSc or equivalent experience.
• Considerable experience (10+ years) of managing GMP Quality Systems and teams, and QC operations.
• In-depth understanding of MHRA, HTA and HSE regulatory framework as applied to small-scale biopharmaceutical production for clinical trials.
• Extensive experience in a supervisory role, with ability to lead, develop, motivate, and organise a small team.
• Proven experience in managing complex Quality systems and ensuring the implementation of SOPs and robust record keeping.
• Experience with PQS processes including deviations, change management, risk management, OOS, audits/self-inspections and product complaints; knowledge of C> analytics related to assay, purity, identity, safety and potency.
• Resilience and flexibility; ability to communicate Quality requirements across the company and lead a quality-focused team.
• Experience hosting regulatory and client audits.

Desirable Qualifications & Experience:

• Qualified Person (QP).
• Experience with technologies used in analysis of cell and gene therapy products (e.g., FACS, HPLC, PCR).
• Knowledge of GLP and routine in-process and QC assay techniques (HPLC, PCR, sterility, mycoplasma, ELISA, SDS-PAGE).
• Qualified Person with experience in the certification of ATMP products.

Competences Required:

• Organisation, planning and time management.
• Pragmatic approach to solving Quality issues.
• Commercial awareness and ability to manage procurement and budgets.
• Clear oral and written communication for direction and decision making.
• Leadership and teamwork; attention to detail; problem solving.
• Ability to build constructive relationships and earn respect.
• Motivation to grow a biotechnology business in the CGT/biopharmaceutical market.
• Proficiency in Office 365 (Word, Excel, PowerPoint).