CooperVision (CVI) is recruiting an Associate Director, Manufacturing Operations.This role will play a critical role in managing and leading start-up phase of new operations and initiatives according to existing goals and regulatory requirements. This includes evaluating needs for infrastructure projects, coordinating with stakeholders, and overseeing the implementation and optimization of new processes. The Associate Director is responsible for managing, directing, and coordinating all aspects of the manufacturing operation. This role ensures that production schedules, standard costs, specifications, and quality objectives are met efficiently and effectively. Additionally, the role involves mentoring team members, establishing performance metrics, and continuously seeking opportunities for improvement. The position is based in Juana Diaz, Puerto Rico, and works onsite.

Essential Functions & Accountabilities:

• Leads the Manufacturing Operations team in delivering on planned production schedules and continuous improvement initiatives resulting in improving the efficiency, reduce cost and enhanced product quality.
• Oversee, track and delivery of manufacturing plant goals and objectives. Owns administrative matters of assigned business unit operations including budget, spending and operational cost (direct & indirect).
• Track & enhance assigned business unit performance through KPIs and efficient reporting and monitoring of data & KPIs to measure effectiveness. Capacity, consumption, scheduling, forecasting, scenario planning and production rationalization, among others.
• Establish clear goals and objectives for the team members, aligning with organizational goals.
• Proactively identify and resolve operations related issues to enhance productivity and reduce waste.
• Manage, lead and collaborate with cross functional teams to align operational vision and manufacturing execution. Assertive stakeholder management from multiple functions, locations including suppliers, partners, and leaders, among others.
• Actively participate, assist, and/or be accountable in the planning and execution of high-complexity operational activities and projects for new and existing products.
• Promote a culture of high performance, execution, innovation and continuous improvement within the assigned business units.
• Communicate effectively with upper management and other stakeholders regarding operations, KPIs, project status and overall performance, efficiency and execution.
• Lead planning and future capability analysis and needs (people, systems and processes). This may include evaluating needs and presenting business case for infrastructure projects.
• Ensure compliance with established regulations and policies applicable. This includes strict compliance with business continuity plans, EHS, Quality and other internal and external audits ensuring compliance with the industry standards, laws, regulations and established CVI policies.
• Provide ongoing support to employees through coaching, mentoring, one on one meetings, performance, development and career planning discussions.
• Other duties as assigned.

Qualifications (Knowledge, Skills, and Abilities):

• In-depth understanding of FDA regulations, ISO standards, Quality System Regulations (QSR), and other relevant medical device regulatory requirements. Strong knowledge of medical device manufacturing processes.
• Proven ability to manage complex projects, including capacity planning, scenario simulation, and production rationalization. Ability to develop, measure, and improve process KPIs to ensure consistent performance improvements
• Advanced analytical skills to perform structured root cause analysis, develop cost models, and drive process improvements.
• Excellent verbal and written communication skills in English and Spanish (Fully bilingual required).
• Advanced proficiency in negotiating and influencing skills. High level of analytical capacity and judgment to resolve complex issues.
• Strong leadership skills with a track record of effective people management, fostering a team-oriented culture and promoting continuous improvement.
• Proficient in MS Office computer applications required (Excel, Word, PowerPoint, Project).
• Advanced working knowledge and/or proficiency of specialized manufacturing and planning apps (ERP, S& OP, scheduling and visualization tools and solutions (software) for manufacturing and quality related documentation.
• Comprehensive knowledge of OSHA safety regulations and best practices in workplace safety.
• Exceptional interpersonal skills, with the ability to support, mentor, and develop employees.
• Ability to lead teams, mentor professionals and indirect reports. Demonstrated ability to coach less experienced staff and technicians.
• Frequent use of a personal computer as well as frequent need to apply mathematical, advanced reading, writing, speaking skills, analytical capacity, and high professionalism and judgment are necessary.
• This role may require travel up to 5% of the time both domestic (within US), and international.

Experience:

• Ten (10) years minimum of experience in the regulated manufacturing industry required.
• Five (5) years of management / leadership experience (responsibility for direct and indirect, functional, department or division operations and oversight) required.
• Ability to lead both strategy and execution aspects within operations / manufacturing required.
• Experience and exposure with early stages of technology transfers, optimization efforts, and critical infrastructure projects / start-ups strongly preferred.
• Experience in ensuring compliance with SOX requirements, conducting internal audits, and preparing for regulatory inspections.

Education:

• Bachelor's degree in business administration, engineering or life sciences required.
• Graduate / advanced degrees (MBA, MS or PhD) and professional certifications (ISO, PMP, Lean / Six Sigma) preferred. EIT license and CIAPR membership also preferred for engineers.

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