Senior Quality Operations Leader

RoslinCT; City of Edinburgh; Hybrid; GBP 75,000 - 100,000; Full time

Benefits offered by this job

31 days annual leave

Group pension scheme

Private healthcare

Cycle2Work scheme

Job summary

RoslinCT is seeking a Senior Quality Operations Manager in Edinburgh BioQuarter to lead the Quality Operations team and ensure GMP compliance across all operational activities.

You will work with cross-functional teams, deputise for the Head of QA when required, and drive KPI tracking, audits, and continuous improvement in a fast-growing cell and gene therapy contract developer/manufacturer.

Qualifications

• Honours degree in life sciences (or equivalent).
• Senior Quality Management experience leading a large quality team.
• Working knowledge of GMP applications to cell therapy and biological products.
• Experience using an electronic Quality Management System.

Responsibilities

• Lead the Quality Operations team to ensure GMP compliance across RoslinCT operations.
• Provide regular KPIs and reports to management with corrective actions.
• Lead internal and external audits and support regulatory/client audits.
• Develop risk-based audit plans and CAPA programs.
• Represent RoslinCT at conferences and stakeholder meetings.

Skills

Quality leadership

GMP knowledge

Stakeholder management

QA auditing

Cell therapy

Electronic QMS

Education

Honours degree in life sciences

Tools

Electronic Quality Management System

Job description

RoslinCT is seeking a Senior Quality Operations Manager in Edinburgh BioQuarter to lead the Quality Operations team and ensure GMP compliance across all operational activities.

You will work with cross-functional teams, deputise for the Head of QA when required, and drive KPI tracking, audits, and continuous improvement in a fast-growing cell and gene therapy contract developer/manufacturer.