Director, External Manufacturing

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 division of CooperCompanies, we're driven by a unified purpose to enable patients to 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.

• External Manufacturing Management:

  • Oversee the management of external manufacturing partners to ensure compliance with quality standards, development timeline, delivery schedules and price.

  • Serve as the primary point of contact for all dealings between the company and external partners.

  • Ensure adherence to terms in the Supply Agreement and Quality Agreement.

  • Resolve technical issues, including investigations, CAPAs, process improvements, and technical transfers.

  • Build SRM governance and drive leadership engagement internally and externally. 

• Supplier Management:

  • Establish and maintain strong relationships with key third-party manufacturers.

  • Negotiate and manage Manufacturing Service Agreements (MSA), contract amendments, and updates as needed.

  • Monitor and control manufacturing costs to ensure efficient use of resources while maintaining product quality.

  • Drive production and cost YOY improvement

• Quality Assurance and R&D:

  • Ensure all external manufacturing activities comply with industry regulations and organizational policies.

  • Support quality management reviews and periodic audits of third-party manufacturers.

  • Ensure deviations are properly investigated and product disposition decisions are made in a timely manner.

  • Support NPI product that aliens with R&D timeline, quality and limitation.

• Performance Monitoring:

  • Monitor manufacturing performance and apply Operational Excellence (OPEX) metrics as appropriate.

  • Ensure timely communication with third-party manufacturers regarding product forecasts, manufacturing, and delivery schedules.

  • Provide regular updates and reports to the Senior Director of Sourcing and Procurement on external manufacturing performance.

• Risk Management:

  • Assess and mitigate risks associated with outsourcing production to third-party manufacturers.

  • Ensure the external manufacturing partners have the required quality systems and documentation to meet regulatory requirements.

  • Lead Make Vs Buy governance and analysis

• Team Leadership:

  • Lead and manage a team of external manufacturing professionals, that supports establish products, NPI and technical ENG, fostering a collaborative and high-performance environment.

  • Create and maintain an inclusive culture and high-performing team.

Travel: 

25% Domestic and/or International Travel

• Education: Bachelor's degree in Supply Chain Management/ ENG, Business Administration, or a related field. A Master's degree or MBA is preferred.

• Experience: Minimum of 10 years of experience in manufacturing operations/External manufacturing management and/or CMO sourcing, with at least 5 years in a leadership role