Quality Operations Leader — GMP & QA Excellence

Energy Jobline CVL; England; On-site; GBP 85,000 - 110,000; Full time

Job summary

Talentmark is recruiting for a Quality Operations Manager to join a well-established global pharmaceutical company based in Hatfield, Hertfordshire. The role covers Quality Operations and Quality Assurance to support GMP compliance for manufacture, packaging, testing, storage and distribution of drug products.

Key duties include leading QA oversight for QC and Production, batch review, KPI reporting, and audit readiness.

Qualifications

• Educated to degree level in a science discipline with extensive QA leadership experience in pharma.
• Strong knowledge of QA, GMP, GDP and manufacturing/packaging processes.
• Experience maintaining and improving Quality Management Systems.
• Ability to interpret global GMP regulations and ensure compliance.
• Proven ability to collaborate across functions, sites and external partners.
• Strong communication and influencing skills at multiple levels.

Responsibilities

• Ensure quality system procedures meet regulatory requirements and promote site adherence.
• Provide QA oversight for QA QC and Production to enable timely batch release and distribution.
• Perform batch review of site and external batch records as required.
• Monitor Quality Management System KPIs and lead Quality Management Reviews.
• Represent Quality Operations during regulatory inspections and audits, and support external audit programs.
• Lead the Product Quality Review (PQR) program, including trend analysis and reporting.
• Author, review, and approve SOPs and other quality documentation such as PQRs, deviations and CAPAs.
• Maintain TrackWise Quality Management System ensuring compliance with GxP and electronic records requirements.
• Deliver GMP and quality systems training, coaching, and mentoring to site personnel.

Skills

Quality leadership

GMP knowledge

Quality systems

Audits

SOP authoring

TrackWise

Cross-functional collaboration

Education

Bachelor's degree in science

Pharma QA experience

Tools

TrackWise

Job description

Talentmark is recruiting for a Quality Operations Manager to join a well-established global pharmaceutical company based in Hatfield, Hertfordshire. The role covers Quality Operations and Quality Assurance to support GMP compliance for manufacture, packaging, testing, storage and distribution of drug products.

Key duties include leading QA oversight for QC and Production, batch review, KPI reporting, and audit readiness.