Danaher Life Sciences
Senior Manager, Customer Regulatory Support
Danaher Life Sciences, Marlborough, Massachusetts, us, 01752
Senior Manager, Customer Regulatory Support
Join to apply for the Senior Manager, Customer Regulatory Support role at Danaher Life Sciences. The Senior Manager will guide a team in a global environment to set strategy and operational approach for Cytiva, leading a group that provides guidance to other Cytiva functions and associates on customer regulatory requirements 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. The Senior Manager, Customer Regulatory Support is responsible for directing direct reports and the business to align with customer regulatory requirements and customer expectations across product development, lifecycle management, manufacturing, and quality assurance. What You Will Do Lead direct reports to set and maintain standards, and provide customer-facing regulatory support documentation, including change control notifications (CCNs), ensuring customer satisfaction and protection of Cytiva intellectual property. Provide guidance to other 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 meet customer expectations and internal stakeholder requirements. Identify and lead cross-functional activities, including developing internal and external documentation to align with industry developments and enhanced customer expectations.
Who You Are
Bachelors 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 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. Experience leading cross-functional activities across global teams. Strong written and verbal communication skills, fluent in English.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
if applicable for role. Ability to travel opportunities for occasional international travel. Preferred Experience Managing a global cross-functional team.
About Danaher/Cytiva
Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs. Danaher supports a culture of continuous improvement and aims to accelerate real-life impact of tomorrows science and technology. For more information, visit . Additional Information
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here. We comply with disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits, please contact: 1-202-419-7762 or applyassistance@. #J-18808-Ljbffr
Join to apply for the Senior Manager, Customer Regulatory Support role at Danaher Life Sciences. The Senior Manager will guide a team in a global environment to set strategy and operational approach for Cytiva, leading a group that provides guidance to other Cytiva functions and associates on customer regulatory requirements 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. The Senior Manager, Customer Regulatory Support is responsible for directing direct reports and the business to align with customer regulatory requirements and customer expectations across product development, lifecycle management, manufacturing, and quality assurance. What You Will Do Lead direct reports to set and maintain standards, and provide customer-facing regulatory support documentation, including change control notifications (CCNs), ensuring customer satisfaction and protection of Cytiva intellectual property. Provide guidance to other 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 meet customer expectations and internal stakeholder requirements. Identify and lead cross-functional activities, including developing internal and external documentation to align with industry developments and enhanced customer expectations.
Who You Are
Bachelors 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 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. Experience leading cross-functional activities across global teams. Strong written and verbal communication skills, fluent in English.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
if applicable for role. Ability to travel opportunities for occasional international travel. Preferred Experience Managing a global cross-functional team.
About Danaher/Cytiva
Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs. Danaher supports a culture of continuous improvement and aims to accelerate real-life impact of tomorrows science and technology. For more information, visit . Additional Information
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here. We comply with disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits, please contact: 1-202-419-7762 or applyassistance@. #J-18808-Ljbffr