Quality Lead

Job Description

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

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 the 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.

If you're passionate about quality, innovation, and making a difference, we want to hear from you. This is your opportunity to thrive in a role that combines leadership, collaboration, and the chance to be a key influencer in our Organon 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 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.

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