Job Description
Organon is hiring a dynamic Quality Lead to join our world‑class manufacturing site in Cramlington, Northumberland. The role leads a critical Quality Function (Bulk or Pack), guiding a dedicated team of QA Specialists and Qualified Persons (QPs). Your leadership ensures robust quality oversight across production operations, driving a culture of built‑in quality and right‑first‑time performance.
Join us fostering a continuous improvement environment where your expertise will be valued and initiatives celebrated. If you're passionate about quality, innovation, and making a difference, this opportunity combines leadership, collaboration, and influence in our mission.
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 QPs.
* 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 company and site HOSHIN, Quality Operations objectives and production priorities.
* Keep up‑to‑date with industry regulations and ensure compliance with quality standards, such as Good Manufacturing Practices (GMP).
* Participate 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 drive initiatives to improve quality and efficiency in packaging operations.
Qualifications, Skills & Experience
* Experience within the pharmaceutical industry is essential.
* Strong written and verbal communication skills with 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.
About Organon
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.
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.
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