Operations Manager - Memphis, Arlington, Franklin, TN (R451941)
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com
Who we want-
Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.
Talent developers. Growth-oriented managers who recruit and hire top-performing talent and prioritize the development of their team members.
Compliance-focused orchestrators. Managers who carefully oversee people, processes, and deliverables to ensure compliance with company policies and procedures
What you will do-
You will manage contract manufacturing activities to ensure that the Stryker delivery, cost, compliance and regulatory objectives are met. You will review short, medium, long-range value stream capacity and material availability forecasting to ensure continuation of supply. You will identify and select alternate supplier and contract manufacturers to ensure sustainability of manufacturing activities. You will draft manufacturing related sections of submissions and other GMP documentation in support of regulatory submission milestones. You will ensure contract manufacturers are compliant with all applicable regulatory requirements. You will provide manufacturing support for new process design and new product development. You will develop budgets and manage expenditures to meet annual departmental and organizational plans.
Background with pharmaceutical drug and device manufacturing management. Strong knowledge of GMP, quality/compliance principles, and regulatory requirements for US and EU products.
Direct experience with contract manufacturing operations and associated relationships – manufacturing of sterile Class II and III devices and aseptic processing of drugs and biologics. Experience with orthopedic devices, drugs, combination products and associated packaging engineering requirements.
Experience with class II or III medical devices that are aseptically processed and terminally sterilized using gamma irradiation or Ethylene Oxide (EtO).
Strong experience with all aspects of supply chain management including import/export and cold chain.
Preferred background in validation and validation concepts.
Ability to operate very effectively in a fast paced, highly integrated, cross-functional team environment. Excellent relationship development/management, interpersonal and communication skills.
What you need –
Bachelor’s degree in a science/business related discipline required (Master’s degree preferred).
8 years of experience in operations management required.
Training in aseptic manufacturing processes.
Know someone at Stryker?
Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program.