Sr. Manager, Plant/Site
PharmaMedTechRegulatory AffairsQuality Assurancegmpfdaiso 13485crorave
Job description
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. THE OPPORTUNITY Thermo Fisher Scientific is establishing a new manufacturing site in Monterrey, Mexico, and we are seeking an experienced Senior Site Manager, to lead the site through start-up and into long-term operations. This is a critical leadership appointment within an established site start-up program. Working closely with the existing cross-functional project team, the Site Leader will take ownership of building the site's leadership team and organization, supporting facility and operational readiness, leading the transfer and ramp-up of manufacturing operations, and ultimately assuming full responsibility for site performance. The site is currently pre-operational with no employees and is expected to grow to approximately 120 colleagues during initial start-up, with significant potential for future growth. KEY RESPONSIBILITIES Provide overall site leadership through start-up, operational readiness, launch, and manufacturing ramp-up. Partner with the established project team to ensure successful delivery of the new Monterrey facility and transition into sustainable site operations. Recruit, build, and develop the plant leadership team and establish a high-performing site organization. Scale the organization from zero to approximately 120 employees, establishing the culture, capabilities, and leadership practices required for future growth. Lead the transfer of manufacturing equipment, processes, products, and business from existing locations into Monterrey. Partner with sending sites and global teams to ensure transfers protect customer supply, quality, cost, and business continuity. Oversee equipment installation, commissioning, qualification, process transfer, and manufacturing ramp-up. Establish a strong culture of safety, quality, customer focus, operational excellence, and continuous improvement from the outset. Embed Lean Manufacturing and Practical Process Improvement (PPI) principles into the site's operating culture. Establish and manage site performance through operational KPIs covering safety, quality, delivery, productivity, cost, and colleague engagement. Ensure compliance with applicable quality, regulatory, environmental, health, and safety requirements. Develop and execute site strategic and annual operating plans, budgets, capacity plans, and productivity objectives. Build strong relationships across Thermo Fisher Scientific's global network and with customers, suppliers, and external stakeholders. Develop the site's longer-term capabilities and capacity to support future business growth. REQUIREMENTS Advanced Degree plus 6 years of relevant experience, or Bachelor's Degree plus 8 years of relevant experience, preferably in Engineering, Science, Business Management, Operations, or a related field. Significant operations leadership experience within sophisticated manufacturing environments. Demonstrated experience in manufacturing site start-ups, major expansions, business transfers, or large-scale operational transformations. Proven ability to recruit, build, and lead high-performing leadership and manufacturing teams. Strong experience transferring manufacturing equipment, processes, products, or operations between locations. Strong track record implementing Lean Manufacturing and continuous improvement methodologies. Experience in FDA-regulated, cGMP, ISO 13485, or comparable quality systems. Strong financial acumen with experience managing operating budgets, capital investments, cost, and productivity. Excellent project, change management, analytical, and problem-solving capabilities. Strong understanding of manufacturing KPIs and data-driven operational management. Experience maintaining strong safety, environmental, quality, and regulatory standards. Outstanding communication and influencing skills with the ability to operate effectively in a global matrix organization. Ability to thrive in a fast-paced start-up environment, moving effectively between strategic leadership and hands-on execution. Ability to travel as required during the site start-up and business transfer phases. Previous greenfield/site start-up experience and experience establishing manufacturing operations in Mexico are highly desirable.
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