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Senior Operations Manager

2 weeks ago

Dublin, Dublin City, Ireland Team Horizon Full time

We are seeking a highly skilled Operations Leader to join our team at Team Horizon in Dublin. This role will be responsible for overseeing the production process, managing lifecycle projects, and CAPEX initiatives.

About the Role:
  • This is an excellent opportunity to work with a world-class manufacturing operation that has a strong track record of delivering high-quality medicines globally.
  • Our company is committed to continuous improvement and innovation, striving for solutions that improve health outcomes and enhance people's lives.
  • As we expand internationally, our client is developing its capability to produce all medicines in Dublin, ensuring continuity of supply.
Key Responsibilities:
  1. Serve as the primary interface between Product Delivery Teams (PDTs) and ADL Manufacturing operations, ensuring seamless communication and collaboration.
  2. Engage with staff members within the Manufacturing department to promote understanding of processes and foster cross-functional teamwork with Facilities & Engineering, Quality, PD, and Supply Chain teams.
  3. Develop, review, and approve Generic Master Batch Records and Parameter Value Lists across Formulation, Filling, and Inspection.
  4. Collaborate on the development, review, and update of Production, Engineering, Operating Procedures, and training materials.
  5. Assist in providing technical training on current processes and project-related aspects to Direct Manufacturing personnel.
  6. Evaluate, plan, and implement solutions for process improvement opportunities, both current and project-related.
  7. Support scheduling and execution of Characterization, Engineering, and PPQ runs, ensuring pre-requisites are met and assessing process performance through observation and data review.
  8. Provide troubleshooting support throughout the project and on the floor during activity execution.
  9. Hold team members accountable for delivery and behaviors within the Manufacturing Support team and associated with the project.
  10. Perform Job Hazard Assessments and Change Control Assessments to determine impact on Manufacturing.
  11. Partner with Learning & Performance to define training strategies for current processes, NPIs, and complex projects.
  12. Consult with Quality Assurance to ensure GMP standards are maintained in line with current SOPs, batch documentation, and licenses.
  13. Develop, review, and update Protocols for manufacturing activities.
  14. Document and approve protocol deviations for manufacturing activities.
  15. Consult with Process Development, Direct Manufacturing, Equipment, and System Owners regarding process changes in an effective and timely manner.
  16. Own and lead change controls as required by the Manufacturing Support team.
  17. Review and approve Bills of Materials.
  18. Develop, review, and update Product Quality Risk Assessments.
Requirements:
  • Strong Project Management and organizational skills, including the ability to follow assignments through to completion.
  • Critical thinking skills: Gather data from key stakeholders, analyze, and interpret information to develop solutions to technical problems of moderate complexity.
  • Negotiation and Influencing skills.
  • Take initiative to identify and drive improvements.
  • Excellent verbal and written communication skills: Strong technical writing skills for GMP documentation (e.g., investigations, procedures, change controls) and good presentation skills.
  • Escalate issues professionally and in a timely manner.
  • Decision-making skills and confidence to challenge others on decisions that impact the manufacturing area.
  • Teamwork and coaching others.
  • Ensure compliance within the regulatory environment.
  • Demonstrated ability to work independently and deliver right-first-time results under minimal direction.