Senior Quality & Compliance Lead GDP & H&S

Culina; St Helens; On-site; GBP 60,000 - 90,000; Full time

Benefits offered by this job

Annual leave 25 days

Private medical cover

Pension scheme

Life assurance

Wellness – EAP

Eye care vouchers

Rewards and recognition

Discount platform

Job summary

Culina IPS is seeking a Quality Manager to lead the Compliance and H&S functions and ensure GDP compliance across the site. You will act as the Named RP on WDA(H) and the Controlled Drug licence, and drive the Quality Management System aligned with MHRA GDP guidelines.

You will manage audits, CAPA/NCR processes, change control, and vendor/ subcontractor oversight while developing training and reporting to support continuous improvement and regulatory readiness.

Qualifications

• Minimum 3–5 years as RP in medical/pharmaceutical industry.
• Experience applying GDP guidelines and HSE practices.
• Strong attention to detail and communication skills.
• Able to manage audits and CAPA processes.
• Proactive in training and change management.

Responsibilities

• Act as Named RP on WDA(H) and Controlled Drug licence.
• Maintain and improve Quality Management System per GDP guidelines.
• Generate and approve GDP documents.
• Create annual audit programme and perform RP audits.
• Approve subcontracted GDP activities.
• Lead MHRA, client and corporate audits.
• Create and review Technical Agreements.
• Manage CAPA and NCR investigations and resolutions.
• Review validation protocols and ensure system validation.
• Decide final disposition of returned/rejected products.
• Coordinate product recalls.
• Manage risk assessment programme and mitigation.
• Oversee change management and documentation controls.
• Oversee sampling and QA release of products.
• Oversee training programmes.
• Review temperature records and manage excursions.
• Host QM Review meetings and produce compliance reports.
• Manage team of 3 (RP, QA Specialists).

Skills

GDP compliance

HSE knowledge

Quality management

Leadership

Auditing

Documentation control

CAPA/NCR management

Communication

IT skills

Job description

Culina IPS is seeking a Quality Manager to lead the Compliance and H&S functions and ensure GDP compliance across the site. You will act as the Named RP on WDA(H) and the Controlled Drug licence, and drive the Quality Management System aligned with MHRA GDP guidelines.

You will manage audits, CAPA/NCR processes, change control, and vendor/ subcontractor oversight while developing training and reporting to support continuous improvement and regulatory readiness.