Quality Lead

Organon; Cramlington; On-site; GBP 70,000 - 90,000; Full time

Job summary

Organon is seeking a Quality Lead for our manufacturing site in Cramlington, Northumberland. You will lead a team of 6 QA Specialists and QPs, ensuring QMS compliance and high-quality packaging operations producing 52 million packs annually for global markets.

The role requires strong leadership, regulatory knowledge, and a continuous improvement mindset to drive first-time-right quality and regulatory readiness at site level.

Qualifications

• Experience in the pharmaceutical industry with leadership and strategic thinking.
• Excellent written and verbal communication with cross-functional teams.
• Proven ability to build relationships and maintain QMS compliance.
• Detail-oriented with proactive, organised work style.

Responsibilities

• Provide QA oversight of production to ensure GMP compliance and quality.
• Document QA processes and production records in the QMS.
• Lead Quality Function with line management of QA Specialists and QPs.
• Address quality issues using root-cause analysis and CAPA.
• Collaborate with production and supply chain to maintain quality metrics.
• Stay updated with industry regulations and participate in audits.

Skills

Leadership

QMS compliance

Cross-functional collaboration

Regulatory compliance

Analytical thinking

Education

Degree in Chemistry

Pharmacy degree

Scientific discipline

Tools

CI tools

Job description

Job Description

Organon is recruiting a Quality Lead to join our world-class manufacturing site in Cramlington, Northumberland. We are in search of candidates with a proven history of leadership and a strong emphasis on ensuring the use of Quality Management Systems (QMS) within a production environment. The successful candidate will possess strategic vision and exceptional critical thinking abilities and be driven and motivated to excel in a fast-paced environment that requires prioritisation and a steadfast commitment to compliance.

Organon is recruiting a Quality Lead to join our world-class manufacturing site in Cramlington, Northumberland. We are in search of candidates with a proven history of leadership and a strong emphasis on ensuring the use of Quality Management Systems (QMS) within a production environment. The successful candidate will possess strategic vision and exceptional critical thinking abilities and be driven and motivated to excel in a fast-paced environment that requires prioritisation and a steadfast commitment to compliance. As a Quality Lead, reporting directly to the Site Quality Head, you will lead a team of 6 direct reports, including QA Specialists and Qualified Persons (QPs), while providing quality oversight for a high-volume pharmaceutical packaging operation producing more than 52 million packs annually for supply to over 70 global markets. Your leadership will be instrumental in fostering a culture of built-in quality and first-time-right performance. We are committed to cultivating an environment of continuous improvement, where your expertise will be recognised and your initiatives applauded. This position offers an exciting opportunity to thrive in a role that merges leadership, collaboration, and the chance to be a pivotal influencer in our Organon mission.

Key Responsibilities

• Provide robust quality oversight of production activities to ensure products manufactured at Cramlington comply with regulatory requirements and exceed internal and external customer expectations.
• Ensure the meticulous documentation of quality control processes and production records through the Quality Management System.
• Lead the assigned Quality Function, with line management duties, focusing on the development and performance of QA Specialists and QPs, emphasising quality leadership and strategic decision-making.
• Address quality-related challenges promptly and effectively, using root cause analysis and corrective actions to prevent recurrence, thereby driving quality improvement.
• Champion collaboration among departments, such as production and supply chain, to ensure seamless operations and consistent quality metrics while adhering to QMS principles.
• Partner with Production to drive quality improvement initiatives aligned with the company's strategic objectives, site HOSHIN, and Quality Operations production priorities.
• Stay current with industry regulations and ensure compliance with quality standards, including Good Manufacturing Practices (GMP).
• Actively participate in quality walk-throughs, cGMP audits, and regulatory inspections, maintaining QMS oversight and regulatory compliance.
• Analyse performance data and quality metrics to identify trends and strategic areas of improvement, prioritizing initiatives that enhance quality and efficiency.

Qualifications, Skills & Experience

• Experience within the pharmaceutical industry is essential, with a strong focus on leadership and strategic thinking.
• Excellent written and verbal communication skills with the capacity to work effectively in—and lead—cross-functional teams.
• Proven ability to forge strong relationships across functional groups, prioritising QMS compliance.
• Exceptional attention to detail with a well-organised and proactive approach to work.
• Degree in Chemistry, Pharmacy, or another scientific or statistical discipline, or equivalent industry experience.
• Continuous improvement mindset, with a background in using CI tools and methodologies.
• QP qualification is desirable but not essential.

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.

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

10%

Number Of Openings

1