Cytiva
Quality and Regulatory Support Manager
Cytiva, Marlborough, Massachusetts, us, 01752
Be part of something altogether life-changing!
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity - so you can grow your career and expand your skills in the long term.
Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.
The Quality and Regulatory Support Manager for Cytiva is responsible for supporting the Business and Customers in a global environment by providing quality documents and regulatory support in ongoing projects, new product development, change control, and in response to customers' requests for quality, regulatory and technical-related information as it pertains to Bioprocess filtration products.
This position is part of the Regulatory Support team located in Marlborough, MA and will be onsite. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.
What you'll do: Support the Business and Customers in a global environment by providing quality documents and regulatory support in ongoing projects, new product development, change control, and in response to customers' requests for quality, regulatory and technical-related information as it pertains to Bioprocess filtration products. Identify and lead cross functional activities, including creating/updating internal and external documentation to align with industry developments and enhanced customer expectations. Function as the regulatory support expert and discussion partner to R&D, QA, Product Management and other functions, and facilitate risk-based decisions. Prepare, update and review regulatory support documentation, including Validation Guides, statements, certificates and other regulatory related documentation for new and existing products. Participate in change control activities and risk assessments, writing change notifications, developing notification qualification packages, and releasing to customers. Respond efficiently and promptly to customers' regulatory based questions and requests, which will include investigations, preparations and delivery of statements and documentation, use of internal and external databases. Who you are:
Bachelor of Science degree in Biochemistry/Chemistry or related field Five or more years of experience in GMP, quality, product management or a related field Understanding of quality and regulatory requirements in the Bioprocess industry Driven with experience leading cross-functional activities across global teams Strong written and verbal communication skills, fluent in English It would be a plus if you also possess previous experience/knowledge of:
Biopharmaceutical/Bioprocess filtration products and techniques
This job is eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.
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. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
The EEO posters are available here.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity - so you can grow your career and expand your skills in the long term.
Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.
The Quality and Regulatory Support Manager for Cytiva is responsible for supporting the Business and Customers in a global environment by providing quality documents and regulatory support in ongoing projects, new product development, change control, and in response to customers' requests for quality, regulatory and technical-related information as it pertains to Bioprocess filtration products.
This position is part of the Regulatory Support team located in Marlborough, MA and will be onsite. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.
What you'll do: Support the Business and Customers in a global environment by providing quality documents and regulatory support in ongoing projects, new product development, change control, and in response to customers' requests for quality, regulatory and technical-related information as it pertains to Bioprocess filtration products. Identify and lead cross functional activities, including creating/updating internal and external documentation to align with industry developments and enhanced customer expectations. Function as the regulatory support expert and discussion partner to R&D, QA, Product Management and other functions, and facilitate risk-based decisions. Prepare, update and review regulatory support documentation, including Validation Guides, statements, certificates and other regulatory related documentation for new and existing products. Participate in change control activities and risk assessments, writing change notifications, developing notification qualification packages, and releasing to customers. Respond efficiently and promptly to customers' regulatory based questions and requests, which will include investigations, preparations and delivery of statements and documentation, use of internal and external databases. Who you are:
Bachelor of Science degree in Biochemistry/Chemistry or related field Five or more years of experience in GMP, quality, product management or a related field Understanding of quality and regulatory requirements in the Bioprocess industry Driven with experience leading cross-functional activities across global teams Strong written and verbal communication skills, fluent in English It would be a plus if you also possess previous experience/knowledge of:
Biopharmaceutical/Bioprocess filtration products and techniques
This job is eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.
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. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
The EEO posters are available here.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.