Role description

Client empowers people with diabetes through innovative continuous glucose monitoring CGM technology At the Ireland facility they are expanding manufacturing and supply chain capabilities to serve global markets

Client is seeking Business Project Managers to lead highimpact programs in manufacturing and supply chain operations driving operational excellence scaleup and commercial readiness

Overall this role requires project governance driving crossfunctional teams to help bring their Athenry facility to commercial readiness interacting with production planning and procurement to help define logistics of SKU changes and inventory planning and managing equipment design development and qualification to build product at internal and external manufacturing locations The Business Project Managers will lead crossfunctional ops teams and collaborate with stakeholders to drive business needs

JobRole Description

As a Business Project Manager

Provide program leadership for complex crossfunctional operations projects from inception through commercialization

Drive commercial readiness for the Athenry facility including new equipmentmouldsautomation qualification implementation and technology transfers

Lead production scaleup of products and processes including Change Order Plan COP closure and FDA filing support where required

Partner across technical teams mechanical process electrical automation software and business functions manufacturing procurement logistics facilities EHS quality regulatory finance IT in a highly matrixed environment

Collaborate with suppliers and external manufacturing partners to ensure successful project delivery

Establish and execute project strategies schedules and resource plans anticipating risks and driving mitigation

Ensure compliance with medical device regulatory standards FDA ISO EU MDR GMP

Communicate project plans risks and progress clearly to leadership and stakeholders

Qualifications

Bachelors degree in Engineering Supply Chain Business or related discipline Masters preferred

12 years experience in project or program management within manufacturing engineering or supply chain medical devices pharma or hightech strongly preferred

Demonstrated success managing technical projects and crossfunctional teams

Knowledge of automation equipment qualification and manufacturing transfer

Strong grasp of regulated change control product development processes and design control

Strong knowledge of manufacturing processes global supply chain operations and ERP systems SAPOracle others

Familiarity with ERPMESWMS systems and operational excellence initiatives

Experience working in regulated industries FDA ISO13485 EU MDR is a plus

Excellent communication and stakeholder management skillsable to influence across functions and leadership levels

Proficiency in MS PowerPoint Excel and project management tools Smartsheet

PMPPRINCE2 or equivalent certification preferred