Job Title
QA Operations Manager
Role Purpose
Responsible for leading QA Operations and Document Control while ensuring the Quality Management System (QMS) remains compliant inspection-ready and aligned with EU UK and US GMP requirements. The role supports operational quality oversight timely product release and the promotion of a strong quality culture across manufacturing operations.
Key Responsibilities
Lead and develop the QA Operations and Document Control teams.
Maintain and oversee the Quality Management System to ensure ongoing GMP compliance.
Manage internal audit and self-inspection programmes and ensure timely follow-up of findings.
Oversee quality events including deviations investigations change controls risk assessments and CAPAs.
Support batch record review to enable timely product release.
Review and approve GMP documentation in line with data integrity and good documentation practices.
Act as SME for QMS and documentation processes during audits and inspections.
Support regulatory inspection readiness and preparation activities.
Provide GxP training and quality guidance to operational teams.
Monitor team objectives KPIs and performance while promoting continuous improvement.
Skills and Competencies
Leadership experience managing quality teams in regulated environments.
Strong knowledge of GMP quality systems and regulatory expectations.
Experience using eQMS systems and managing quality processes.
Strong organisational communication and problem-solving skills.
Experience and Qualifications
Degree in a relevant scientific discipline.
Significant QA or compliance experience within a GxP environment.
Experience in sterile or aseptic manufacturing preferred.
Working knowledge of EU UK and US GMP regulations.
Required Experience:
Manager
Job TitleQA Operations ManagerRole PurposeResponsible for leading QA Operations and Document Control while ensuring the Quality Management System (QMS) remains compliant inspection-ready and aligned with EU UK and US GMP requirements. The role supports operational quality oversight timely product re...
Job Title
QA Operations Manager
Role Purpose
Responsible for leading QA Operations and Document Control while ensuring the Quality Management System (QMS) remains compliant inspection-ready and aligned with EU UK and US GMP requirements. The role supports operational quality oversight timely product release and the promotion of a strong quality culture across manufacturing operations.
Key Responsibilities
Lead and develop the QA Operations and Document Control teams.
Maintain and oversee the Quality Management System to ensure ongoing GMP compliance.
Manage internal audit and self-inspection programmes and ensure timely follow-up of findings.
Oversee quality events including deviations investigations change controls risk assessments and CAPAs.
Support batch record review to enable timely product release.
Review and approve GMP documentation in line with data integrity and good documentation practices.
Act as SME for QMS and documentation processes during audits and inspections.
Support regulatory inspection readiness and preparation activities.
Provide GxP training and quality guidance to operational teams.
Monitor team objectives KPIs and performance while promoting continuous improvement.
Skills and Competencies
Leadership experience managing quality teams in regulated environments.
Strong knowledge of GMP quality systems and regulatory expectations.
Experience using eQMS systems and managing quality processes.
Strong organisational communication and problem-solving skills.
Experience and Qualifications
Degree in a relevant scientific discipline.
Significant QA or compliance experience within a GxP environment.
Experience in sterile or aseptic manufacturing preferred.
Working knowledge of EU UK and US GMP regulations.
Required Experience:
Manager
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