Strategic Quality Manager – Respiratory & Warehouse Ops

1054 GlaxoSmithKline Services Unlimited; Ware; On-site; GBP 60,000 - 80,000; Full time

Job summary

GlaxoSmithKline plc in Ware is seeking a Quality Manager to ensure all manufacturing and non-manufacturing activities comply with SOPs, cGMP and regulatory standards. You will assess quality impacts, manage quality systems and ensure products are manufactured, packaged and released to registered specifications.

Based at our new oral solid dose facility, you will lead CAPA reviews, oversee GMP procedures, and coach staff to uphold high quality and compliance while collaborating with R&D and

Qualifications

• BSc in Scientific, Technical or Engineering discipline.
• Experience in current Good Manufacturing Practice environment.
• Experience in applying Quality Management Systems (QMS).

Responsibilities

• Liaise with functions to handle incidents affecting quality; record, remediate and investigate deviations.
• Review and endorse CAPA proposals.
• Provide QA approval of GMP procedures and documents; monitor quality processes.
• Manage receipt, processing and closure of customer complaints.
• Support investigation of vendor complaints.
• Identify and resolve quality issues in manufacturing, packaging, warehouse and non-manufacturing areas.
• Ensure changes are controlled and impacts assessed.
• Ensure product released/shipped meets quality standards.
• Provide quality oversight of facilities, equipment and personnel including GMP areas.
• Support Distribution Risk Assessments.
• Coach staff on quality standards via TAP, Gembas and quality meetings.

Skills

Quality management

GMP

CAPA

Regulatory compliance

GxP regulations

Education

BSc in Scientific/Technical/Engineering

Tools

GMP procedures

Job description

GlaxoSmithKline plc in Ware is seeking a Quality Manager to ensure all manufacturing and non-manufacturing activities comply with SOPs, cGMP and regulatory standards. You will assess quality impacts, manage quality systems and ensure products are manufactured, packaged and released to registered specifications.

Based at our new oral solid dose facility, you will lead CAPA reviews, oversee GMP procedures, and coach staff to uphold high quality and compliance while collaborating with R&D and