Quality Assurance Manager

1007 Organon Pharma (UK) Limited; Cramlington; On-site; GBP 70,000 - 100,000; Full time

Benefits offered by this job

Flexible work arrangements

Job summary

Organon is seeking a Quality Assurance Manager to lead the QA department at the Cramlington site in Northumberland. You will drive quality oversight for all QA activities, manage risk programmes, and support inspections and product quality reviews.

The role covers day-to-day leadership, development, and budgeting for the QA team to align with site objectives. You will oversee Quality Risk Management, Compliance Excellence, and ensure effective interactions with regulatory authorities and

Qualifications

• Degree in Chemistry, Pharmacy, or a related scientific discipline.
• Demonstrable experience within a pharmaceutical manufacturing environment.
• Proven leadership and people management experience within a GMP-regulated environment.
• Qualified Person (QP) eligible desirable but not essential.
• Strong communication, influencing, and stakeholder management skills.
• Demonstrated ability to lead and collaborate effectively across cross-functional teams.
• Ability to build and maintain strong working relationships across all levels of the organisation.
• Strong attention to detail, organisational skills, and a commitment to quality and compliance.

Responsibilities

• Lead, coach and develop the QA team, providing day-to-day direction, prioritisation and support, while managing departmental resources and budget to ensure delivery of site quality objectives.
• Ensure Procedures, Policies, and Guidelines are reviewed and implemented.
• Coordinate routine, process change, and new product stability programmes.
• Lead the site’s Quality Plan and compliance assessment, communicating progress to senior management.
• Lead the site’s QMS project and Quality Council meetings.
• Develop and manage Annual Product and Equipment Reviews.
• Manage Laboratory support systems and supplier management programmes.
• Oversee Lifecycle Documents, Records Management, and site training.
• Support QA function for Manufacturing Operations and ensure compliance with regulations.

Skills

Leadership

People management

Stakeholder management

Cross-functional collaboration

Communication

Attention to detail

Quality & compliance

Education

Degree in Chemistry/Pharmacy

Job description

Job Description Secondary Job Description Organon is hiring a Quality Assurance Manager to join our world class manufacturing site in Cramlington, Northumberland. In this role, you will lead the Quality Assurance department at the site, ensuring quality oversight for all QA activities. You will manage and oversee site programmes for Quality Risk Management, Quality and Compliance Excellence, and support Permanent Inspection Readiness and Product Quality Reviews. You will also be responsible for the day-to-day leadership, development and performance of the QA team, ensuring priorities are effectively managed, resources are aligned to support site objectives, and departmental budgets are effectively managed.

Role Responsibilities

• Lead, coach and develop the QA team, providing day-to-day direction, prioritisation and support, while managing departmental resources and budget to ensure delivery of site quality objectives.
• Ensure Procedures, Policies, and Guidelines are reviewed and implemented.
• Coordinate routine, process change, and new product stability programmes.
• Lead the site’s Quality Plan and compliance assessment, communicating progress to senior management.
• Lead the site’s QMS project and Quality Council meetings.
• Develop and manage Annual Product and Equipment Reviews.
• Manage Laboratory support systems and supplier management programmes.
• Oversee Lifecycle Documents, Records Management, and site training.
• Support QA function for Manufacturing Operations and ensure compliance with regulations.

Qualifications, Skills & Experience

• Degree in Chemistry, Pharmacy, or a related scientific discipline.
• Demonstrable experience within a pharmaceutical manufacturing environment.
• Proven leadership and people management experience within a GMP-regulated environment.
• Qualified Person (QP) eligible desirable but not essential.
• Strong communication, influencing, and stakeholder management skills.
• Demonstrated ability to lead and collaborate effectively across cross-functional teams.
• Ability to build and maintain strong working relationships across all levels of the organisation.
• Strong attention to detail, organisational skills, and a commitment to quality and compliance.
• Experience driving continuous improvement initiatives and leading interactions with regulatory authorities and external auditors.

Who We Are

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.

Employment Details

• Employee Status: Regular
• Relocation: No relocation
• VISA Sponsorship: No
• Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites
• 10% Flexible Work Arrangements
• Work Week Shift: Not Indicated
• Valid Driving License: Hazardous Material(s):
• Number of Openings: 1