Industrial Operations Director

5 hours ago

Cork, Cork, Ireland beBeeManufacturing Full time €1,499,999 - €1,999,999
Job Title

The Vice President, Ireland Manufacturing Operations role is a key position within our organization.

This individual will oversee the stage commercialization, manufacturing, test and release of our products for international markets.

They will provide leadership to an organization responsible for Manufacturing, Packaging, Analytical Test and Release, Engineering, Supply Chain, Drug product Scaleup and Commercialization of commercial products at the Cork Manufacturing site and clinical manufacturing of drug candidates at the Cork facility.

The successful candidate will be responsible for providing cross-functional leadership as the Site Lead for the Cork Manufacturing Plant.

Responsibilities
  • Leadership: Provide leadership and direction to the Ireland Manufacturing Operations organization;
  • Cross-Functional Leadership: Lead the cross-functional Ireland Manufacturing Operations Leadership team in the development of medium and long-term strategic plans and lead the management team in the execution of operational plans;
  • Talent Management: Hire, mentor, and develop team members within the organization. Set performance goals and hold employees accountable for their performance. Lead the performance and talent management processes for the site;
  • Culture Development: Build and maintain a site culture consistent with our values, and with an added emphasis on quality and safety;
  • Financial Management: Develop and manage department budget and ensure company accounts comply with statutory accounting practices;
  • Regulatory Compliance: Accountable for fulfilling legal and fiscal responsibilities as a company director for our organization enshrined in company law;
  • Product Oversight: Advance commercial product portfolio by providing overall CMC oversight, direction and decision making;
  • Strategic Directions: Provide strategic directions to all commercial products through interactions with each product's PDM (CMC) team;
  • Site Operations: Serve as a senior member of the PDM Manufacturing Leadership Team responsible for developing and establishing clinical & commercial manufacturing strategy and site operations;
  • Scale-Up and Technical Transfer: Oversee late-stage commercialization, scale up and technical transfer of development drug products to commercial manufacturing. Support drug product registration and commercial launches;
  • Innovation: Evaluate and implement new technologies and approaches to drive innovation in drug product development, testing, and manufacturing;
  • Project Execution: Drive development and implementation of new systems to improve project execution and data management;
  • Collaborations: Lead collaborations with Pharmaceutical Development and Manufacturing functions such as Quality, Technical Development, CMC Regulatory, Product Strategy, SPDM Strategy and Operations, and Global Supply Chain;
  • Regulatory Support: Support regulatory filings by guiding the draft, review, and approval of CMC sections; support associated agency interactions and product-related inspections;
  • Technical Support: Provide technical support to internal and external cGMP manufacturing operations;
  • External Relations: Interact with governmental bodies as company representative for legal/statutory issues;
  • Business Partnerships: Interface between the company and other pharmaceutical companies, business and scientific organisations, main customers, suppliers and external media;

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