Position Details

Reporting to the Site Director this role will provide Operations Leadership to the Sligo manufacturing site.The role is responsible for overseeing & managing manufacturing operations to ensure compliance with GMP & regulatory requirements. This role demands a strong people leader with a deep understanding of biopharmaceutical production processes, quality control & operational efficiency.

EDUCATION
• Bachelor’s degree in Life Science or equivalent. Extensive relevant industry experience may supersede degree requirements.

EXPERIENCE
• Minimum of 10 years’ experience in a similar role, ideally in a biopharmaceutical manufacturing facility, with at least 5 years’ experience in a managerial role, preferably on a Site Lead Team.
• Track record of managing GMP compliant manufacturing operations.
• Experience with regulatory, client inspections & audits.
• Academic & practical experience with operational excellence & process improvement initiatives is highly desirable.  
• Advanced knowledge of Excel, Word & PowerPoint. MS Project an advantage.

RESPONSIBILITIES 
• Ensure all manufacturing activities adhere to EHS regulations. 
• Work with EHS to promote a culture of safety & improvements within the operations team.
• Lead, mentor & develop an expanding team of manufacturing professionals, fostering a culture of excellence, teamwork & continuous improvement.
• Develop & implement strategies to achieve targets, standards & cost efficiency whilst ensuring appropriate level of preparedness of any escalations, fostering a culture of openness, collaboration & attention to detail to achieve schedule/project task delivery.
• Ensure all manufacturing activities comply with GMP, regulatory & company standards.
• Maintain area in GMP Compliance & ensure operations team training is current.
• Oversee the writing & review of SOPs, batch records & documentation.
• Manage day-to-day manufacturing operations.
• Focusing on near term horizon actively assess & recognize where action is required. Work to generate alternatives, options & choosing effective options.
• Partner with TSA to monitor & optimise production processes to improve yield, efficiency & quality.
• Identify opportunities for process improvement & lead initiatives to enhance efficiency. 
• Identify & implement lean manufacturing principles & CI methodologies.
• Collaborate with cross functional teams to build an effective working relationship.
• Participate in internal/external audits & inspections, addressing any findings and implementing corrective actions.
• Track & trend relevant metrics to ensure operations are performing effectively & efficiently.
• Actively participate in the SLT and S&OP processes to assess workload, identifying gaps or imbalances & reallocating resources or making hiring decisions to optimize staffing levels & ensure efficient operations as the site expands with capital investments, TT & commercial manufacture. 
• Ad hoc duties as required.

CORE COMPETENCIES
• Strong leadership & people management– this role requires management of all operations competencies.
• In-depth knowledge of GMP regulations & biopharmaceutical production processes.
• Excellent problem solving, analytical & decision-making abilities.
• Ability to prioritise workload & set direction.
• Strategic thinker with ability for forward planning.
• Strong communication/interpersonal skills.
• Flexible & agile in support of site’s overall mission