Job Overview

The Operational Site Lead – Sterile and Aseptic Manufacturing will oversee teams responsible for producing veterinary pharmaceutical products to the highest standards, ensuring timely global distribution. They will drive performance and foster a culture of compliance and continuous improvement across key manufacturing areas to meet customer order deadlines. Strict adherence to the Norbrook Quality Management System and Environmental Health & Safety standards is essential within the manufacturing environment. The Operations Site Lead will ensure that all products are manufactured in compliance with regulatory authority requirements worldwide.

Main Activities/Tasks

• Lead and manage large teams in a complex, highly regulated environment, driving performance and compliance
• Coach and mentor team members to drive high performance, maintaining high standards of work.
• Identify development needs and skills gaps within the team, fostering growth and continuous learning.
• Spearhead significant operational transformations, including site turnarounds and large-scale process optimisations.
• Promote accountability and high performance while cultivating cross-functional collaboration.
• Maintain a deep knowledge and understanding of regulatory authority expectations (MHRA, FDA, EU GMP) for aseptic manufacturing.
• Promote and drive a ‘safety culture’ throughout the team, ensuring adherence to the highest safety standards.
• Ensure products are manufactured in compliance with Good Manufacturing Practices (GMP) and within the parameters of the Quality Management System.
• Lead the change management process for addressing manufacturing issues, ensuring all actions comply with regulatory requirements.
• Perform regular internal compliance audits to ensure the site is audit-ready at all times.
• Lead and successfully navigate regulatory audits in sterile and aseptic production environments.
• Foster a culture of continuous improvement, embedding a “Quality” mindset within the team to optimize performance and efficiency.
• Actively participate in continuous improvement programs, ensuring manufacturing activities are cost-effective, minimizing rejects, and maximizing yields.
• Identify and implement process improvements to enhance output and operational efficiency across the facility.
• Implementing Lean, Six Sigma, or other efficiency methodologies that we are adopting in an aseptic/sterile environment.
• Take responsibility for meeting Operational and Compliance KPIs for the manufacturing facility.
• Driving operational excellence, meeting ambitious production targets, and resolving bottlenecks/issues quickly.
• Oversee the coordination and planning of the manufacturing schedule to ensure customer requirements are consistently exceeded.
• Collaborate with other site leads to ensure changes are implemented consistently across sites and avoid siloed operations.
• Work closely with departments such as Engineering, Process Excellence, Validations, and Quality to ensure full compliance with GMP and customer requirements.
• Foster teamwork and open communication across departments to ensure seamless operation and issue resolution.
• Ensure that all manufacturing records are completed accurately and compliantly in line with regulatory and company requirements.
• Support external audits and inspections as needed, ensuring all necessary documentation and procedures are up to date and in compliance with regulatory standards.
• Drive high standards of performance within the team, identifying and addressing performance issues where necessary.
• Continuously assess team performance and implement strategies to improve overall productivity and results.

Criteria:

• A degree or third level qualification in Pharmacy, Science, Engineering or Mathematics (or a closely related area) or at least 5 years’ experience in a manufacturing environment in the pharmaceutical industry
• A minimum of 10 years’ experience in a management role, with at least 5 years in a senior leadership role overseeing sterile operations
• Proven ability to lead, motivate, and mentor a diverse team, including coaching less experienced team members.
• Proven experience reporting to executive leadership and influencing strategic decision-making at the C-suite level
• Strong understanding of pharmaceutical manufacturing processes, including solid oral dose, aseptic techniques, non-aseptic processes, API manufacturing, and packaging.
• Knowledge of regulatory, quality, and validation requirements in the pharmaceutical industry.
• Experience in product launch activities and associated challenges.
• Ability to think strategically while maintaining a keen attention to tactical detail, effectively balancing high-level planning with on-the-ground execution.
• Demonstrated ability to ensure a compliant and safe working environment, maintaining high product quality and adhering to regulatory standards.
• Experience with Environmental Health & Safety (EHS), including conducting risk assessments, COSHH assessments, and NEBOSH certifications.
• Exceptional leadership abilities, with experience in motivating, training, and developing team members.
• Demonstrated success in driving performance improvements and fostering a culture of continuous development within the team.
• Strong knowledge of document control and management systems.
• Experience with documentation related to a Quality Management System (QMS) and understanding of production documentation processes.
• Excellent IT proficiency, particularly in Microsoft PowerPoint, Excel, and Word, with the ability to effectively use these tools for reporting, analysis, and presentations.
• Excellent organizational skills with a strong ability to manage multiple tasks and priorities effectively.
• Outstanding communication skills, both written and verbal, with the ability to implement change successfully and engage with stakeholders at all levels.

Duration: Full Time, Permanent

Location: Newry

Additional Information:

Applicants should be able to provide proof that they have a right to work in the UK at the time of their application. Applicants who are unable to provide this proof will not be considered.

We regret that applications received after the closing date and time will not be accepted.

We are unable to sponsor or take over sponsorship of a Visa.

Contact: recruitment@norbrook.co.uk

Norbook Laboratories Limited employs a workforce with members of all sections of the community and is committed to appointing people purely on the basis of merit. In accordance with our equal opportunities policy, we would particularly like to welcome applicants from the Protestant Community.