GMP Compliance Leader - Pharma Quality & Inspection Readiness

Organon LLC; Cramlington; On-site; GBP 85,000 - 110,000; Full time

Job summary

Organon LLC in the UK is hiring a Compliance Manager to join our manufacturing site in Cramlington, Northumberland. The role is a key IPT SME for GMP, quality, safety, and regulatory compliance, driving a culture of quality and ensuring inspection readiness across the site.

You will lead governance reviews, manage quality metrics, CAPAs, deviations, and change controls, provide guidance to operational teams, champion continuous improvement, and develop the team through coaching and succession

Qualifications

• Significant experience within a pharmaceutical manufacturing or regulated healthcare environment.
• Strong knowledge of GMP requirements and pharmaceutical quality systems.
• Experience managing deviations, investigations, CAPAs, and change controls.
• Leadership and influencing skills.
• Strong analytical and problem-solving capability.
• Excellent written and verbal communication.
• Risk-based decision making.
• Attention to detail and compliance focus.
• Stakeholder management.
• Planning and organisational skills.
• Continuous improvement mindset.

Responsibilities

• Serve as the IPT compliance lead and SME for GMP, regulatory compliance, quality systems, and patient safety, fostering a strong quality culture across the department.
• Provide compliance guidance to operational teams, lead governance reviews, oversee quality metrics, risks, action plans, and present compliance performance to site leadership.
• Drive compliance with health, safety, and environmental requirements, supporting investigations, risk assessments, audits, and effective CAPA implementation.
• Lead departmental change controls, assessing quality, regulatory, validation, operational, and compliance impacts while ensuring timely and effective implementation.
• Lead deviation investigations using structured root cause analysis, ensuring robust, compliant investigations and sustainable corrective and preventive actions.
• Maintain a continuous state of inspection readiness, coordinating responses to regulatory, customer, and internal audits and driving closure of observations.
• Facilitate quality risk management activities, ensuring risks are identified, assessed, mitigated, documented, and periodically reviewed using risk-based decision making.
• Drive continuous improvement, quality culture, GMP compliance, data integrity (ALCOA+), good documentation practices, and Right First Time performance.
• Develop team capability through coaching, mentoring, talent management, succession planning, and fostering a culture of accountability, ownership, and continuous learning.
• Lead, engage, and inspire the team to deliver business goals with integrity, ensuring compliance with company policies, processes, governance standards, and effective workforce planning.

Skills

GMP knowledge

Quality systems

Leadership

Risk-based decision making

Audit management

CAPA management

Education

Degree in Science, Pharmacy, Engineering, Quality, or related discipline

Job description

Organon LLC in the UK is hiring a Compliance Manager to join our manufacturing site in Cramlington, Northumberland. The role is a key IPT SME for GMP, quality, safety, and regulatory compliance, driving a culture of quality and ensuring inspection readiness across the site.

You will lead governance reviews, manage quality metrics, CAPAs, deviations, and change controls, provide guidance to operational teams, champion continuous improvement, and develop the team through coaching and succession