QC Manager - Analytical

We are looking for a driven individual with strong experience in QC Analytical operations and a passion for people to join our QC Analytical department us as QC Manager - Analytical.

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 QC Manager - Analytical role. This role is well suited to an individual with experience in managing a QC GMP Analytical Biology laboratory or team looking to join a dynamic, growing company and promote best practices in QC.

The Role:
You will be a key member of our QC Management team and will be responsible for co-ordinating the efforts of the QC Analytical team in delivering the testing/monitoring requirements within RoslinCT to ensure the release of our cell and gene therapy products. You will ensure that our products are quality controlled to GMP standards, manage in-house and outsourced GMP testing and oversee the collation of all QC documentation necessary for batch release. You will also be responsible for overall management, development and professional growth of our talented QC Analytical team and will play an active role in shaping our company.

Responsibilities:
Work at RoslinCT is fast paced, and no two days are the same. Your responsibilities will therefore be varied, but will include;
• Management of the QC Analytical function within RoslinCT, ensuring that sampling and testing is performed against set specifications in a timely manner and in alignment with approved schedules.
• Direct management of the QC Analytical laboratories to meet operational requirements.
• Authoring and review of change controls, deviations/investigations as well as test methods, specifications and SOPs.
• Supervision of the review of laboratory data and the close out of deviations.
• Review and approval of all QC related documentation within the QMS to ensure work is compliant with the relevant standards/guidelines.
• Continuous review of QC procedures to ensure their compliance and identification of any appropriate improvements.
• Management of regulatory requirements from MHRA and FDA, ensuring Data Integrity principles are deployed within the team and that issues are escalated in a timely manner.
• Development, collation and reporting of key quality/business related metrics, and use of such metrics to drive a culture of continuous improvement and process efficiencies within areas of responsibility.
• Management of documented procedures for ensuring all raw materials used for Manufacturing are checked, tested and released against agreed specifications.
• Collaborating with the company-wide Management team in technical and operational discussions.
• Ensuring training needs of the QC Analytical team are met.
• Line managing our QC Analytical Supervisor, and potentially Senior Analysts, being responsible for managing employee performance and professional development with appropriate support from RoslinCT Management and our HR.
• Undertaking regular 1-2-1 meetings with QC Analytical team members and holding team meetings to foster a professional, inclusive and supportive team environment.
• Leading in the recruitment of QC Analytical staff, as required, to develop and shape the QC Analytical team as the business grows.
• Continued coaching and development of team members to help them meet both their career and personal development goals ensuring a cohesive, productive and highly motivated working environment.
• Development and continuous improvement of the awareness of QC staff in the requirements of GMP and best practice for applying GMP within RoslinCT activities.

Qualifications:
You will hold a BSc, MSc or PhD in a Life Science or related discipline.

Skills and Experience:
You will be able to demonstrate:
• Significant experience in leading or managing a GMP QC Analytical team or laboratory within the pharmaceutical industry, the biologics industry or stem cell activities.
• A clear understanding of GMP and Quality Control.
• Demonstrable ability to take decisions, to analyse information in a logical manner and to prepare coherent investigative and/or technical reports.
• Strong skills in, and a passion for, people management and team development.

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 commute and wellbeing.
• We have a dedicated Social Committee and other regular company events such as BBQs, team drinks, quizzes, parties and 5-aside football.
• Career Progression & Training Opportunities are provided for all of our staff to help you achieve your goals and grow professionally and personally.

Values:
A key part of working at RoslinCT is being able to embody our company values, which are integral to the work we do here. As such, you should be able to demonstrate:
• Passion for customer satisfaction.
• Ability to support a ‘one team’ approach.
• Great communication.
• Commitment to personal growth and development.
• Accountability for your work.

Location:
We are based at Edinburgh BioQuarter, which acts as a hub for Scottish Life Science with close links to the University and the Royal Infirmary.
Employer Value Proposition:
RoslinCT is seeking the best, brightest, and most passionate cell and gene therapy talent with a diverse range of skillsets, experience, and perspectives. We offer industry-leading annual leave allowances, career development opportunities and employee benefits, as well as working groups and social activities, and are dedicated to developing the next generation of experts and future leaders of our company. If you want to utilise your skills and talent in a state-of-the art company that truly changes lives, you belong at RoslinCT.