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The Senior manager, Customer Regulatory Support is responsible for guiding direct reports and the business in a global environment to set the strategy and operational approach for Cytiva. The senior manager will lead a team that is providing guidance to other Cytiva functions and associates involved in product development, lifecycle management, manufacturing, and quality assurance regarding applicable customer regulatory requirements and customer expectations on our products, processes, and documentation to ensure market access for Cytiva products.
Job Responsibility:
Lead direct reports to set and maintain standards, and in providing customer facing regulatory support documentation, including change control notifications (CCNs), ensuring customer satisfaction and protection of Cytiva Intellectual Property
Provide guidance to other relevant Cytiva functions regarding customer expectations and required information and standards
Lead and set the direction for the team, individual contributors and direct reports
Contribute to the strategy and operational plan for the department in close collaboration with other critical functions in Cytiva
Develop people, organization, and operating mechanisms to successfully meet customer expectations and requirements of Cytiva internal stakeholders
Identify and lead cross functional activities, including developing internal and external documentation to align with industry developments and enhanced customer expectations
Requirements:
Bachelor’s degree in a science/engineering or related field required, advanced degree beneficial
Minimum 7-10 years’ experience in product management, product support, or quality in a life sciences company
Understanding of relevant regulatory, quality and scientific fundamentals applicable to Bioprocess products
Demonstrated ability to balance resources, timing and quality of outcomes
Proven leadership and change management skills
Driven with experience leading cross-functional activities across global teams
Strong written and verbal communication skills, fluent in English
Ability to travel – opportunities for occasional international travel