Senior QA Officer/supervisor

We are looking for a driven individual to join us as a **Senior Quality Assurance Officer/Supervisor - Quality Systems, depending on experience level.**

We are RoslinCT, a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapies that change people’s lives. Collaborative, dedicated and talented people are at the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilising ground-breaking science.

As part of our continued growth, we are now recruiting across all of our teams including this Senior QA Officer/Supervisor role. This role is well suited to an individual that is looking to take the next step in their QA career through developing, managing and co-ordinating the Quality Systems teams at RoslinCT.

**The Role**:
You will be a key member of our Quality Systems team, within the larger Quality Assurance department, and will be responsible for providing technical leadership to the Quality Systems team, as well as supporting the Quality Compliance Manager in managing the RoslinCT Quality Management System (QMS) and establishing effective systems to monitor QMS compliance. At Supervisor level, you will also have line management responsibility for a team of QA Officers.

**Responsibilities**:
Work at RoslinCT is fast paced, and no two days are the same. Your responsibilities will therefore be varied, but will include;
- Performing data collection and analysis for KPIs, chairing Management review meetings and leading reporting of Annual Product Quality Review.
- Development and management of a system to monitor key QMS elements ensuring timely completion of actions and QMS commitments.
- Development and leading of the site Inspection Readiness Program.
- Leading the hosting of external inspections and customers audits by managing pre-audit, audit execution and audit response activities.
- Ensuring a Self-inspection program is in place, supported by trained internal auditors and aligned with current regulatory focus and expectations.
- Ensuring systems are in place to ensure GXP changes are adequately documented, assessed, implemented and verified.
- Ensuring systems are in place to facilitate the identification and tracking of Corrective and/or Preventive Actions to ensure CAPAs are executed in a timely manner and CAPA effectiveness is evaluated.
- Ensuring RoslinCT MIA(IMP) licences remain correct and up to date.
- Proactively identify and lead the implementation of continuous improvement opportunities within the Quality Systems group and the wider business.
- Initiate and progress artwork process when new specifications are provided by clients including ensuring adequate controls are in place, approval of artwork change controls and development of the artwork process.
- **Supervisor level only**:

- Line management of a team of QA staff; you will be responsible for managing employee performance, development, recruitment and, if applicable, conduct with appropriate support from the Quality Compliance Manager and HR.
- Accountability for the performance and quality of output of own team and financial accountability for timesheet sign-offs.
- Contribution to the QA Management team by working collaboratively with senior colleagues to ensure consistent approach to management and problem solving.
- Responsibility for day-to-day co-ordination and decision-making in respect of team, escalating more complex matters to the Quality Compliance Manager as required.

**Qualifications**:
You will hold an Honours degree in a Life Science or related field, or equivalent relevant experience.

**Skills and Experience**:
You will be able to demonstrate:

- Experience in QA within a relevant GMP Manufacturing industry (e.g. biologics or pharmaceuticals) and in supervising staff.
- A clear understanding of GMP, regulatory and accreditation systems and quality management.
- Competence and confidence in reporting and presenting internally / externally (MHRA visits, customer visits, training, auditing).

**Benefits**:
In addition to a competitive salary and the opportunity to join an exciting, rapidly expanding company delivering life-changing therapies, we offer:

- 31 days of annual leave, plus 4 public holidays - when you have been with us for three years, we will give you an extra day holiday and when you reach 5 years, you’ll get an extra two days’ holiday.
- Competitive company pension scheme - we contribute up to 8% of your salary (depending on length of service) to ensure that you are all set for the future.
- Group Life Cover - you are automatically covered for three times your basic salary to give you peace of mind for you and your family.
- Healthcare Cashback, Mental Health/Wellbeing support and gym discounts via our Healthcare plan.
- Staff discounts on food, drink, electronics, entertainment and electricals.
- Access to our Cycle2Work Scheme so you can save up to 42% on a new bike to help with your