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  • Location: Newry
  • Salary: Competitive Salary
  • Job Type:Permanent

Posted 4 days ago

  • Sector: Manufacturing, Leadership
  • Contact: Jude Southon
  • Contact Email: jude.southon@nextphaserecruitment.com
  • Contact Phone: 1403216216
  • Start Date: ASAP
Operations Site Lead
Are you a dynamic leader with a passion for operational excellence in sterile pharmaceutical manufacturing? This is your opportunity to take charge of a highly visible, impactful role where you’ll lead complex operations, drive performance, and elevate compliance standards on a global stage.
The Opportunity
As Operations Site Lead, you will oversee high-performing teams responsible for the manufacture of veterinary pharmaceutical products in a sterile and aseptic environment. You'll ensure seamless, compliant production and timely delivery to international markets while fostering a culture of safety, quality, and continuous improvement.
You’ll play a central role in site-wide transformation initiatives, operational optimization, and strategic leadership — making a measurable difference in a fast-paced, highly regulated environment.
Key Responsibilities
  • Lead, inspire, and manage large cross-functional teams in a GMP-regulated sterile manufacturing setting.
  • Drive a high-performance culture rooted in compliance, accountability, and excellence.
  • Coach and develop team members to support ongoing growth, performance improvement, and succession planning.
  • Spearhead site turnaround initiatives, transformational change, and process optimization projects.
  • Ensure compliance with global regulatory authority standards (MHRA, FDA, EU GMP).
  • Lead change management efforts, internal audits, and readiness for external regulatory inspections.
  • Champion continuous improvement initiatives to enhance efficiency, reduce waste, and improve yield.
  • Implement Lean, Six Sigma, and other process improvement methodologies within an aseptic/sterile setting.
  • Own and deliver on Operational and Compliance KPIs, consistently exceeding production and quality goals.
  • Oversee planning and scheduling to meet customer order deadlines and business objectives.
  • Collaborate cross-functionally with Engineering, Validation, Quality, and Process Excellence teams.
  • Ensure accurate, compliant completion of manufacturing documentation and QMS records.
  • Build a culture of transparency, communication, and cross-departmental alignment.
What You Bring
  • Degree in Pharmacy, Science, Engineering, Mathematics, or a related field, or equivalent industry experience.
  • 10+ years in manufacturing leadership, with at least 5 in a senior sterile/aseptic operations role.
  • Deep expertise in pharmaceutical manufacturing, including aseptic processing, API, packaging, and product launches.
  • A proven track record of leading site operations, engaging teams, and influencing strategic decisions at the executive level.
  • Strong understanding of global regulatory and validation requirements (FDA, MHRA, EU GMP).
  • Experience managing EHS protocols, including NEBOSH, COSHH, and risk assessments.
  • Skilled in performance management, mentoring, and developing talent in regulated environments.
  • Proficiency in QMS documentation and digital tools (Excel, PowerPoint, Word).
  • Strategic thinker with a strong eye for operational detail, capable of managing complex, fast-moving priorities.
  • Outstanding communication and interpersonal skills with an ability to engage stakeholders at all levels and implement change effectively.