Quality Lead

Job Description

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

Organon is an equal opportunity employer and welcomes applicants from diverse backgrounds.

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 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.

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.

Benefits & Working Conditions

• Annualized Salary Range: Pay ranges are specific to local market and therefore vary from country to country.
• Employee Status: Regular
• Relocation: No relocation assistance
• VISA Sponsorship: No sponsorship
• Travel Requirements: 10%

Requisition ID: R539331

Number of Openings: 1