Quality and Regulatory Support Manager
Quality and Regulatory Support Manager
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Job Description
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnology
At Cytiva one of Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.
Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement you help turn ideas into impact innovating at the speed of life.
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake lifesaving 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. Take your next step to an altogether lifechanging career.
Learn about the Danaher Business System which makes everything possible.
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 technicalrelated 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 youll 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 technicalrelated 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 riskbased 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 crossfunctional 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
Cytiva a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
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 Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.
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Join our winning team today. Together well accelerate the reallife impact of tomorrows 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.
For more information visit www.danaher.
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 to request accommodation.
Required Experience:
Manager
Employment Type
Full-Time
