Job Description

Description

The Quality Assurance Specialist will be responsible for ensuring the standards of the Pharmaceutical Quality System (PQS) across CGT Catapult MICs (Stevenage and Braintree) are maintained in a fit for purpose state of control, and improved, for a multi-purpose, multi-client facility. This will involve maintenance and improvement of associated procedures for controlling key quality and business processes in addition to helping develop the measures and governance structures to be employed to maintain visibility on the processes and interactions within and across them.


The Quality Assurance Specialist will also be responsible for managing the quality interactions between CGT Catapult and our Collaborators and will be the primary quality point of contact for a defined Collaborator.


Reporting to and with the guidance of the Quality Assurance Lead, this role will ensure that activities across CGT Catapult MICs (Stevenage and Braintree), via proactive engagement, meets the standards and expectations of two key stakeholders: the regulatory authorities and Collaborators.

Key Responsibilities

To work within a multi-disciplinary team to take a tactical role in the design, implementation, and establishment of suitable governance processes to assure consistent GMP compliance across both CGT Catapult MICs To ensure both CGT Catapult MICs maintain a PQS that meets the requirements of enhanced or alternative collaboration models as the business requires Maintain processes, including GMP document control and training, deviations and change control needed for successful site compliance to regulatory guidelines Generation and approval of quality documents such as SOPs and policies, to ensure they contain appropriate technical content, formatting and unambiguous wording Participate in quality events such as deviations, change controls, audits and risk Assessments for various roles such as owner, SME or QA approval Provide general Quality subject matter expertise for the MIC's operations, and provide guidance in the creation and completion of QMS records Participate in the review the performance of the QMS at planned intervals and provide regular reporting by Collation of quality metrics for analysis: to ensure its continuing suitability, adequacy and effectiveness and propose improvements Participate in the execution of a GMP internal audit program including the identification and implementation of appropriate corrective actions and a process to track their completion Provide compliance support by providing advice and facilitating the escalation of compliance issues through the appropriate routes Provide general Quality subject matter expertise for the facility operations and deputise for the QA Lead when required Actively participate in scheduled GMP compliance assessments and general walkaround/GEMBA to confirm site compliance and seek improvement opportunities Participate in Kaizen activities to identify and implement continuous improvement opportunities, both operationally and within the Product Quality System (PQS) Participate in the preparation for and the management of regulatory agency and Collaborator inspections Based on business requirements, in addition to execution of quality records, individuals may assume process owner and SME for key QMS activities, including but not limited to: Non-Conformances, Deviations & CAPA Change Control Self-Inspection Vendor Assurance Contamination Control Strategy Document Management including Periodic Reviews Data Integrity Master Control and Q-Pulse maintenance, management of routine changes to the system and periodic upgrades Provide support to activities across CGT Catapult MICs (Stevenage and Braintree) with periodic travel to the CGT Catapult Braintree facility

Experience:

Experience in an operationally focused Quality Assurance role providing quality oversight to manufacturing operations, using risk-based approaches to assure product safety, quality and efficacy Experience working within controlled cGXP environments for the pharmaceutical manufacturing of products such as, sterile biologicals, vaccines, cell or gene therapies, ATMPs or IMPs Experience working in or collaborating with R&D environments Demonstrable experience in interacting with the regulatory authorities Experience in interacting with clients and Collaborators Demonstrable experience working as a Quality Specialist (or equivalent) in biologics and preferably cellular and/or gene therapies Experience in the ownership and maintenance of Quality Systems including Deviation Management, Change Control, CAPA, Complaints etc Experience in delivering continuous improvement activities to develop robust, compliant, Quality Systems

Skills, Knowledge & Expertise

Highly motivated, pragmatic and practical to support the mission of the Cell Therapy Catapult to accelerate the development of a commercial cell-based therapy industry in the UK Desire to establish a high-profile career within the cell and gene sector and the personal drive to help push the sector to be a commercial success Sound knowledge of MHRA/EMA and FDA regulatory environments and requirements Resilient, with the ability to manage multiple and varied tasks and prioritise workload within a fast-paced professional environment Confidence and ambition to provide pragmatic and considered GMP advice High level interpersonal, communication (oral and written) skills Accurate with strong attention to detail Able to evaluate complex situations and find solutions for them in a professional manner Project ownership and pride in its delivery; strong organisational skills Having a passion for delivering excellent customer service Flexibility towards work assignments and new learning Ability to work well under pressure, to work independently and to be able to take the initiative when completing tasks Ambitious, collaborative, driven Comfortable operating autonomously once goals and objectives are set Ability to quickly establish credibility and build rapport and trust Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives and to respond to a wide range of customer and management needs Proven diplomacy skills with diverse groups of internal and external stakeholders A positive attitude towards learning, personal and professional development Keeps up to date with professional knowledge, expertise and best practice Willingness to travel

Education / Qualifications

Educated to Degree level in a life sciences discipline Member of a professional organisation e.g. RSC, SOB, CQI Lead Auditor Accreditation

About Cell and Gene Therapy Catapult

The Cell and Gene Therapy Catapult (CGT Catapult) is an independent innovation and technology organisation committed to the advancement of cell and gene therapies with a vision of a thriving industry delivering life changing advanced therapies to the world. Its aim is to create powerful collaborations which overcome challenges to the advancement of the sector.

With experts covering all aspects of advanced therapies, it applies its unique capabilities and assets, collaborates with academia, industry and healthcare providers to develop new technology and innovation.

The Cell and Gene Therapy Catapult works with Innovate UK.

CGT Catapult is committed to providing an equal, diverse, and inclusive work environment where everyone's contributions are valued. We celebrate differences, empower, and inspire everyone, because when everyone is included, everyone wins. In 2024, we received bronze accreditation from Inclusive Employers.