Job Description

Job Responsibilities

Develop and execute the company's manufacturing and operations strategy in alignment with overall corporate goals. Lead long-term capacity planning, technology adoption, and manufacturing excellence initiatives. Partner with R&D, Quality, and Commercial teams to ensure smooth technology transfer and product scale-up. Represent the manufacturing organization in executive meetings and cross-functional decision-making. Ensure effective supply chain management, including vendor qualification, procurement, and inventory control. Establish key performance indicators (KPIs) to monitor and optimize operational performance. Ensure full compliance with ISO 13485 and other global regulatory requirements. Build, mentor, and retain a high-performing operations team. Drive a culture of accountability, collaboration, and innovation. Champion employee engagement and continuous learning initiatives. Develop and manage annual operating budgets for manufacturing and operations. Identify cost-saving opportunities without compromising quality or compliance. Support due diligence and integration efforts in mergers, acquisitions, and strategic partnerships.

Qualifications and Experience

Bachelor's degree in Biomedical Engineering, Biotechnology, Manufacturing, Computer Science and Technology or a related field. Minimum 12 years of experience in the IVD or medical device industry, with at least 3 years in a senior leadership role. Proven experience in managing large-scale, regulated manufacturing operations. Deep understanding of ISO 13485, FDA, and IVDR compliance requirements. Strong business acumen and experience in strategic planning, budgeting, and resource management. * Excellent leadership, communication, and stakeholder management skills.