About this role
CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a business unit of CooperCompanies (Nasdaq: COO), we're driven by a unified purpose of helping people experience life’s beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com.
Responsibilities
- Lead and manage all Media Manufacturing value stream operations, including formulation, aseptic filling, and packaging activities, ensuring safe, compliant, and efficient execution of production plans to meet customer demand, quality standards, and business objectives.
- Establish production priorities and allocate resources based on customer requirements, product urgency, manufacturing capacity, and material availability to ensure uninterrupted production flow and achievement of delivery commitments.
- Drive performance across Safety, Quality, Delivery, Cost, Inventory, and People metrics while maintaining compliance with GMP, ISO, regulatory, and company quality system requirements within ISO Class 5, 7, and 8 cleanroom environments.
- Monitor manufacturing performance, identify bottlenecks and production constraints, and collaborate with Quality, Engineering, Supply Chain, Planning, Maintenance, and Technical Operations teams to resolve issues and improve operational effectiveness.
- Ensure optimal inventory levels and material availability to support production requirements while maintaining appropriate safety stock levels and maximizing capacity utilization.
- Lead investigations of production deviations, non-conforming materials, scrap, and quality issues, implementing corrective and preventive actions to improve product quality, reduce waste, and mitigate manufacturing risks.
- Review and approve manufacturing and quality system documentation, including Engineering Change (ECRs), NCMRs, OALs, Variances, CAPAs, procedures, and other compliance-related records to ensure timely resolution and regulatory compliance.
- Drive continuous improvement initiatives utilizing Lean Manufacturing, Operational Excellence, and problem-solving methodologies to improve productivity, reduce costs, eliminate waste, enhance quality, and increase customer satisfaction.
- Partner with Supply Chain, Buyer/Planners, and suppliers to evaluate material requirements, resolve supply challenges, and support business continuity, risk mitigation, and growth objectives.
- Identify, evaluate, and support the implementation of new technologies, equipment, automation, and process improvements that enhance operational efficiency, reliability, quality, and scalability.
- Develop, coach, and motivate a high-performing team by fostering a culture of accountability, employee engagement, continuous learning, and operational excellence while ensuring effective succession planning and talent development.
- Manage departmental budgets and resources, monitor manufacturing costs, and support cost reduction initiatives while achieving financial performance objectives.
- Serve as a key escalation point for customer-related quality, delivery, and service issues, partnering with Commercial, Quality, and Technical teams to ensure timely resolution and customer satisfaction.
- Provide regular updates to senior leadership regarding operational performance, business risks, improvement opportunities, and strategic initiatives while ensuring alignment with organizational goals and priorities.
- Promote and uphold a culture of safety, quality, compliance, and continuous improvement, ensuring all employees adhere to applicable GMP, ISO, OSHA, environmental, and company requirements.
Qualifications
Knowledge, Skills and Abilities:
- Demonstrated ability to lead manufacturing operations by understanding both strategic objectives and the operational details required to achieve business goals.
- Strong analytical and problem-solving skills, with the ability to collect, interpret, and communicate complex operational and business data to support decision-making and drive performance improvements.
- Proven leadership capabilities with experience developing, coaching, motivating, and managing high-performing teams in a fast-paced manufacturing environment.
- Comprehensive understanding of manufacturing processes, material flow, capacity planning, and production scheduling. Experience in aseptic processing and cleanroom manufacturing environments (ISO Class 5, 7, and 8) is preferred.
- Proven track record of driving operational excellence through cost reduction, waste elimination, process simplification, productivity improvements, and continuous improvement initiatives.
- Strong project management and change leadership skills, with the ability to identify opportunities, build cross-functional alignment, and successfully implement sustainable solutions.
- Excellent communication and interpersonal skills, with the ability to effectively communicate in English and Spanish, both verbally and in writing.
- In-depth knowledge of manufacturing equipment, equipment qualification, process validation, and risk management methodologies.
- Strong knowledge of Lean Manufacturing principles and continuous improvement tools. Six Sigma Green Belt certification or higher is preferred.
- Advanced proficiency in Microsoft Office applications, including Excel, Word, PowerPoint, Power BI, and other business analytics tools.
- Thorough understanding of GMP regulations, FDA requirements, ISO standards, and quality systems applicable to regulated manufacturing environments. Experience with medical device, pharmaceutical, biotechnology, or media manufacturing operations is preferred.
- Strong financial acumen with experience managing budgets, evaluating operational performance metrics, and driving improvements in cost, quality, delivery, and inventory performance.
Experience:
- A minimum of 8 years experience in managing a manufacturing environment that is both labor and machine intensive.
Education:
- Engineering degree in Mechanical Engineering, Industrial Engineering, Chemical Engineering, Material Engineering, Biomedical Engineering, Microbiology or similar
- Master’s degree in Mechanical Engineering, Industrial Engineering, Chemical Engineering is a plus.
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