Quality Lead, GMP & QMS Leadership in Pharma

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

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.