RoslinCT is a global CDMO focused on Advanced Cell and Gene Therapies. It was established in 2006, built upon the ground-breaking cloning technology of Dolly the Sheep. RoslinCT is one of the first to produce clinical-grade human pluripotent stem cells and developed the first CRISPR-edited cell therapy product for a major inherited disorder, taking it from early development to commercialization.
Senior Quality Assurance Officer
Location: NINE, 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 a Senior Quality Assurance Officer to join our team!
* Support the Quality Assurance Supervisor in leading the team of Quality Assurance Officers in the day-to-day activities required to support RoslinCT.
* Lead the review and management of RCT document types including but not limited to Standard Operating Procedures (SOPs), batch records, production material specifications, to ensure compliance with company policies, practices, and relevant standards and guidelines.
* Support the Quality Assurance Supervisor in the determination of training requirements for the QA team. Act as trainer and lead training for the QA Officers in specific SOPs as required.
* Write, implement, review, and maintain SOPs, policies, and other documentation for QA activities.
* Lead the QA Officers in the administration, review, and approval of key quality management system documents (QMS) including Incident Reports, Change Controls, CAPA and Risk Assessments.
* Lead and perform data review audits (Batch Production Records, Validation Documents and Development Documentation, Quality Control Data as required).
* Support the Qualified Person and Head of Quality in the definition and maintenance of the annual internal and external audit programs for RCT.
* Perform and review internal and external audits to determine compliance with GMP and identify areas for improvement.
* Reviewing and approving suppliers / service providers including supporting with audits of critical suppliers where required.
* Supporting the Quality Assurance Supervisor & Manager with hosting customer audits and regulatory inspections.
* Act as principal project lead for new and existing RCT projects providing advice and guidance to the RCT team with support from the Quality Assurance Supervisor & Manager.
* Maintain and deliver training in quality related topics to RCT personnel including annual GMP training.
* Lead the Quality Assurance team in preparation of weekly and monthly reports to be submitted to senior management and RCT departments to ensure visibility of QMS requirements and performance including the compilation of quality metrics to facilitate monitoring and management of the RCT Quality System.
* To perform tasks as reasonably expected by the Quality Assurance Supervisor & Manager.
* Support the Quality Assurance Supervisor & Manager in the management of other Quality Assurance Officers within the Quality Team including day to day activities, training in procedures associated with the role and preparation of the role to deputise/assume responsibilities of the Senior Quality Assurance Officer role as required.
About you
* Experience in a relevant area of activity (e.g. pharmaceutical industry / stem cell activities).
* Demonstrable leadership qualities, communication, interpersonal and motivational skills.
* Demonstrable ability to take decisions, to analyse information in a logical manner and to prepare coherent investigative and/or technical reports.
* A clear understanding of GMP, regulatory and accreditation systems and quality management.
* Demonstrate competence in reporting and presenting internally / externally (MHRA visits, customer visits, training, auditing).
* Competent in computer packages including Microsoft Office and an electronic quality management package.
* Exceptional organisational and planning skills with the ability to plan whilst delivering results to deadline.
* Excellent communication and interpersonal skills.
* Excellent oral and written communication skills; able to explain technical or complex concepts in a clear format to both technical and non-technical audiences.
* Able to effectively manage and influence stakeholders’ and customer expectations.
* Excellent administration and record keeping skills.
* Ability to learn and share knowledge with the management team and the wider team where appropriate.
Qualifications
* A relevant Honours degree in a Life Science or related subject, or equivalent professional qualification.
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.