Operations Quality Improvement Team (OQIT) Lead

Location: Edinburgh BioQuarter

Who are we?

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 the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilising ground-breaking science.

Find out more about what we do here!

Why join us?

• The opportunity to join a rapidly expanding company which is changing lives, giving you the skills and experience to develop your career.
• A generous salary package – we reward our people at the level they deserve.
• 31 days of annual leave, plus 4 public holidays which increases with tenure.
• A competitive company pension scheme to help you save for the future.
• Group Life Cover – you are automatically covered for three times your basic salary to give you and your family peace of mind.
• Private healthcare and access to mental health/wellbeing support as your health and wellbeing means a lot to us.
• Flexible benefits such as retail discounts and access to the Cycle2Work scheme.

Your new role

• We are looking for an Operations Quality Improvement Team (OQIT) Lead to join our team!
• The OQIT Lead will report directly to the Senior Section Manager of Manufacturing Support Services.
• You will be responsible for line management, progression, and the development of the OQIT Team.
• Lead on developing and managing Quality Improvement initiatives across the company that ensure compliance with internal policies and internal/external standards and guidelines.
• Act as liaison between Quality Assurance, Manufacturing and other Functional Departments to ensure appropriate regulatory standards are maintained for all projects.
• Support the Manufacturing Department with all activities related to maintenance of the Quality Management System and Batch Disposition.
• Provide technical leadership of manufacturing projects and act as the technical point of contact for the client (where applicable).
• Act as the point of contact and responsible person for the workload progression of Batch Record Review Team and QMS Team; ensuring that KPIs are met.
• Input into Quality Management work such as Manufacturing Batch review, Deviations, Risk Assessments, CorrectActive and Preventative Actions (CAPAs) and/or Change Controls by working collaboratively with relevant departments.
• Lead the administration, review and approval of key quality documents including deviations, Change Controls, CAPAs and Risk Assessments, and Batch Sign-Off.
• Support the review and management of RoslinCT document types including Standard Operating Procedures (SOPs) to ensure compliance with company policies, practices and relevant standards and guidelines.

About you

• Experience in stem cells, gene/cellular therapies or cell banking.
• Proven track record of successfully supervising a team in a GMP environment and the ability to lead colleagues through various projects and initiatives.
• Experience following SOPs and using technical RCA and FMEA techniques.
• Solution-based thinking with an ability to simplify complex situations/systems and develop lean initiatives.
• Experience of cGMP regulations particularly in respect of aseptic processing, documentation, and record management.
• Working knowledge of MHRA, FDA, EMA, PICS and ISO regulations.
• Experience with technical writing and demonstrable competence in reporting and presenting internally/externally (regulatory visits, customer visits, training, auditing)
• Experience of project management within a client facing environment.
  
• Demonstrable leadership qualities, interpersonal and motivational skills.
• Able to learn and share knowledge with the Manufacturing department and the wider company where appropriate.

Qualifications

• PhD or Masters Life Science degree or equivalent qualification/experience.
• Minimum 5 years’ experience in Sterile Manufacture- and/or Quality-related role.
• Green Belt certification in Lean Six Sigma tools is desirable.

Next Steps

If this sounds like you, then please hit ‘Apply’ now. We will ask you to upload your CV and complete a short application form detailing why you are interested and why we should hire you.

At RoslinCT, we’re all about inclusivity and creating a fair, welcoming workplace. Our goal is to make sure everyone knows they’re valued and encouraged to be themselves, whether they’re our employees, customers, or partners.

We take pride in being an equal opportunity employer. We treat all applicants fairly and don’t discriminate based on any protected characteristics. So, no matter who you are, we welcome your application with open arms.

If you’ve got any specific needs or concerns regarding accessibility during the recruitment process, don’t hesitate to reach out to us at jobs@roslinct.com. We’re here to assist and make things as smooth as possible for you.