Compliance Manager

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 is hiring a Compliance Manager to join our world-class manufacturing site in Cramlington, Northumberland., As a key individual contributor within the Integrated Process Team (IPT), the Compliance Manager will act as the subject matter expert for GMP, quality, safety, and regulatory compliance. The role is responsible for driving a strong culture of quality and compliance, supporting continuous inspection readiness, identifying and mitigating compliance risks, and ensuring the effective implementation of quality systems. Working closely with operational and cross-functional teams, the Compliance Manager will provide expert guidance and oversight to support the safe, reliable, and compliant manufacture of pharmaceutical products while championing continuous improvement across the site.,

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

Preferred Education, Experience and Skill:

• Lean Six Sigma or Continuous Improvement qualification.
• Experience with regulatory inspections and audit management., Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

Flexible Work Arrangements: Shift: Valid Driving License
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman. As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants. Search Firm Representatives Please Read Carefully Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.