Quality Assurance Lead

The Quality Assurance Lead will ensure that the S-MIC meets the standards and expectations of the regulatory authorities and Collaborators.

The Quality Assurance Lead will provide direct line management to a team of QA Specialists, who are responsible for the overall health and management of the S-MIC Quality Management System (QMS) and governance thereof. Under the guidance of the Head of Quality Assurance, the Quality Assurance Lead will also facilitate translating strategic direction into the QMS, through policies, procedures, and working practices.

The Quality Assurance Lead will also be the primary quality contact for Collaborators in the S-MIC and be responsible for resolving shared queries and managing Collaborator compliance with relevant aspects the QMS.

Key Accountabilities:

  • To work within a multi-disciplinary team to take a supporting role in the maintenance and improvement of the QMS assuring the consistent GMP compliance of the S-MIC for cell and gene therapy product manufacture.
  • Participate with (or delegate for) the Head of Quality Assurance in Collaborator interactions and securing new collaborations.
  • Responsible for day-to-day management and development of a high performing Quality Assurance team.
  • Provide tactical support for the preparation for and the management of regulatory agency and Collaborator inspections, including active participation in audits and inspections and directly interacting with inspectors.
  • Support the Head of Quality Assurance in ensuring the QMS is maintained and fit for purpose for a multi-purpose, multi-collaborator facility.
  • Assist the Head of Quality Assurance on the integration of Collaborator processes and operations into the QMS.
  • Provide subject matter expertise for the facility operations.
  • Provide compliance support by providing advice and facilitating the escalation of compliance issues through the appropriate routes.

Other Quality Duties

  • Promote the awareness of Quality requirements throughout the company and Collaborator community, and train team members in quality related activities.
  • Support the maintenance of processes, including GMP document control and training, required for successful site compliance to the QMS.
  • Develop data analysis methodologies and reporting tools that demonstrate the performance of the QMS and the S-MIC’s compliance to same at a planned frequency and provide regular reporting to ensure its continuing suitability, adequacy, and effectiveness and propose improvements.
  • Support and participate in the execution of a GMP internal audit programme including the identification and implementation of appropriate corrective actions and a system to track their completion.
  • Support in the establishment of quality requirements for external suppliers, including a supplier quality audit programme for external third parties.

Experience:

  • Experience of establishing and/or improving GMP quality systems in sterile manufacturing, ideally cell and/ or gene therapies, otherwise other biologics.
  • Experience in interacting with the regulatory authorities.
  • Experience in supplier auditing, IRCA certified auditor (desirable).

Knowledge / Skills / Competencies:

  • Highly motivated, pragmatic and practical to support the mission of the Cell and Gene Therapy Catapult to accelerate the development of a commercial cell and gene-based therapy industry in the UK.
  • Desire to establish a high profile career within cell and gene sector and the personal drive to help push the sector to be a commercial success.
  • High level communication (oral and written) skills.
  • Extensive knowledge of EU / MHRA and FDA regulatory environments.
  • Familiar with global standards related to quality e.g., ISO 9001.
  • Resilient, with the ability to manage multiple and varied tasks and prioritise workload within a fast-paced and professional environment.
  • Flexible and pragmatic, able to learn quickly and respond flexibly to project needs and priorities.
  • Project ownership and pride in its delivery.
  • 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.
  • Proven coaching/mentoring ability.
  • Comfortable operating autonomously once goals and objectives are set.
  • Able to evaluate complex situations and find solutions for them in a professional manner.
  • Accurate with strong attention to detail.
  • 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 coupled with the ability to build relationships essential.
  • Proven experience of continuous improvement.
  • High degree of motivation, problem solving skills and innovative thinking.
  • Experience of standard Microsoft packages.
  • Experience in interacting with clients and Collaborators.
  • 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 recognised professional body (desirable).

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.