Senior Quality Operations Manager

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

The Senior Quality Operations Manager will be responsible for leading the Quality Operations team, who oversee operational activities within RoslinCT, ensuring compliance with GMP requirements.

You’ll have prior experience leading a large Quality team, with a passion for ensuring workload is manageable and targets are consistently met and delivered on time. The successful applicant will be required to work closely with all departments in RoslinCT and deputise for the Head of QA when required.

Further responsibilities include but are not limited to:

• Provide regular reports to RoslinCT’s management team identifying deficiencies in the QMS and advising on the necessary corrective action.
• Generate, review and analyse meaningful Key Performance Indicators (KPIs) for the team to highlight areas of improvement in the business.
• Ensure compliance is fully met across systems and procedures with UK, EU and US regulations and legislation for ATMPs and Stem Cell Manufacture. In addition, you’ll ensure compliance with the applicable HTA regulations and the requirements of the MHRA and FDA.
• Monitor and analyse quality metrics and trends to identify areas for improvement, liaising with applicable stakeholders to implement improvement initiatives.
• Make sure QA are effectively represented on all large RoslinCT technical projects.
• Lead on a program for auditing all internal operations and services used in processes, and lead on responses to third party audits.
• Professionally represent RoslinCT at conferences and business meetings.
• Maintains up to date knowledge of current industry trends, standards and methodologies as it relates to Good Manufacturing Practice (GMP).
• Provides QA review of protocols and participates on Operational Review Teams to identify operational risks and collaborates with study team in development of risk mitigation strategies.
• Develops risk-based audit plans for assigned programs, ensures audits are conducted in accordance with the plan, reviews audit reports, evaluates responses and CAPA plans in accordance with company standards and policies.
• Support and/or leads Regulatory and Client Audits.
• As required, leads quality issue investigations, root cause analysis and CAPA development and assist operational teams implementing corrective and preventive actions in support of compliance.
• Support in the implementation of continuous quality improvement initiatives.
• Quality Assurance review of PQS documents; including but not limited to Master Batch Records, Protocols, SOPs and Quality Events.
• Analyses risk and propose remedial, corrective and /or preventive actions.
• Assist in preparation of budgeting and scheduling.
• People Management activities including Talent Acquisition/ Recruiting/Interviewing/ Selection/Onboarding and Performance Management (goals, monitoring, reviews).
• Monitoring /Supporting Employee Engagement and Retention and Succession Planning;
• Accomplishing staff results by communicating job expectations, planning, coaching, training and developing personal growth opportunities through IDPs.