Quality Lead

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.

Secondary Job Description

Who We Are:

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. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.  Our Vision is clear: A better and healthier every day for every woman.

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. 

Search Firm Representatives Please Read Carefully 
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Annualized Salary Range

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

10%

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1