Job Description
Organon is recruiting a Quality Lead to join our world‑class manufacturing site in Cramlington, Northumberland. We are searching for 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 six 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.
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, prioritising initiatives that enhance quality and efficiency.
- Identify opportunities for process enhancements and spearhead initiatives to bolster quality and efficiency in operations.
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.
Equal Opportunity Employer
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.
Benefits & Miscellaneous
Employee Status: RegularRelocation: No relocationVISA Sponsorship: NoTravel Requirements: 10%
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