Operations Site Lead

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.
• 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.
• 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.
• 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.

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.
• 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.
• Experience with documentation related to a Quality Management System (QMS) and understanding of production documentation processes.
• Excellent organizational skills with a strong ability to manage multiple tasks and priorities effectively.

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