Quality Lead

Job Description

Organon is hiring a dynamic Quality Lead to join our world‑class manufacturing site in Cramlington, Northumberland.

Organon is an equal opportunity employer and welcomes applicants from diverse backgrounds.

As a Quality Lead, you will lead one of our critical Quality Functions (Bulk or Pack), guiding a dedicated team of QA Specialists and Qualified Persons (QPs). Your leadership will ensure robust quality oversight across production operations, driving a culture of built‑in quality and right‑first‑time performance.

Join us in fostering an environment of continuous improvement, where your expertise will be valued and your initiatives celebrated.

Key Responsibilities

• Provide robust quality oversight of all production activities to ensure products manufactured at Cramlington comply with regulatory requirements and meet internal and external customer expectations.
• Ensure accurate and complete documentation of quality control processes and production records.
• Lead the assigned Quality Function (Bulk or Pack), including line management, development and performance of QA Specialists and QP’s.
• Deliver strong quality leadership, addressing quality‑related issues promptly and effectively, using root cause analysis and corrective actions to prevent recurrence.
• Lead the Quality team in Pack or Bulk and work collaboratively with other departments, such as production and supply chain, to ensure seamless operations and consistent quality.
• Partner with Production to sponsor and deliver quality improvement initiatives aligned with the company and site HOSHIN, Quality Operations objectives and production priorities.
• Keep up‑to‑date with industry regulations and ensuring compliance with quality standards, such as Good Manufacturing Practices (GMP).
• Participation in quality walk‑throughs, cGMP audits and regulatory inspections.
• Provide oversight of Quality management systems to maintain regulatory compliance.
• Analyse performance data and quality metrics to identify trends and areas of improvement.
• Identify opportunities for process enhancements and driving initiatives to improve quality and efficiency in the packaging operations.

Qualifications, Skills & Experience

• Experience within the pharmaceutical industry is essential.
• Strong written and verbal communication skills with the ability to work effectively in – and lead – cross‑functional teams.
• Ability to build strong working relationships across functional groups.
• Excellent attention to detail with a well‑organised and proactive approach to work.
• University degree in Chemistry, Pharmacy, or another scientific or statistical discipline (or equivalent).
• Strong continuous‑improvement mindset, with experience using CI tools and methodologies.
• QP qualification is desirable but not essential.

Benefits & Working Conditions

• Annualized Salary Range: Pay ranges are specific to local market and therefore vary from country to country.
• Employee Status: Regular
• Relocation: No relocation assistance
• VISA Sponsorship: No sponsorship
• Travel Requirements: 10%

Requisition ID: R539331

Number of Openings: 1