Senior Manager, Customer Regulatory Support

Danaher • Marlborough, MA

114d

About The Position

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. This position reports to the Department Director for Regulatory Care and is part of the Customer Regulatory Support team within QARA located in Marlborough, MA or Uppsala, Sweden and will be an on-site role.

Requirements

• Bachelor's degree in a science/engineering or related field required, advanced degree beneficial.
• Minimum 5-7 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.

Nice To Haves

• Managing a global cross functional team.

Responsibilities

• 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.

Benefits

• Comprehensive health care program.
• Paid time off.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree