About the job

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.

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.
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-organized 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.

Responsibilities

About the job

Job Description

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.
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-organized 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.