Reporting to and with the guidance of the Head of Quality Assurance, this role will ensure that the manufacturing centre, via proactive engagement, meets the standards and expectations of two key stakeholders; the regulatory authorities and potential collaborators.
- To work within a multi-disciplinary team to take a tactical role in the governance and oversight of the activity associated with delivering beneficial use to the facility expansion.
- To act as a single point of contact for all Quality interactions between the manufacturing centre and third-party contractors responsible for delivering the expansion.
- Participate in the preparation for and the management of regulatory agency and client inspections related to the expansion project.
- Ensure the PQS is maintained in a fit for purpose state of control for a multi-purpose, multi-client facility and ensure consistency between existing processes and procedures and those associated with the extension.
- Provide general quality subject matter expertise to the expansion project team.
- Provide compliance support by providing advice and facilitating the escalation of compliance issues through the appropriate routes.
- Promote the awareness of quality requirements and support the evolution of the quality culture throughout the company.
Experience must include the following skills:
- Participation in multidisciplinary project teams with experience in facility and/or cleanroom qualification activity and in sterile manufacturing processes, ideally ATMP’s or biologics.
- Sound knowledge of EMA and FDA regulatory environments and requirements.
- Familiar with global standards related to quality e.g. ISO 9001.
- Experience working as a Quality Specialist or equivalent in biologics and preferably cellular and/or gene therapies.
- Ability to manage multiple and varied tasks and prioritize workload with attention to detail.
- Comfortable operating autonomously once goals and objectives are set.
- Excellent interpersonal, written and verbal communication skills.
- Confidence and ambition to provide pragmatic and considered GMP advice.
- Having current and up to date professional knowledge, expertise and best practice.
- Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives.
- Ability to quickly establish credibility and build rapport and trust.
- A good team player, with strong organisational skills.
Educated to Degree level in a life sciences discipline.
Member of a professional organisation e.g. RSC, SOB, CQI etc. (Desirable).