Quality and Regulatory Support Manager

Danaher • Marlborough, MA

14d • Onsite

About The Position

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 Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s 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 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. Take your next step to an altogether life-changing 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 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.

Requirements

• Bachelor of Science degree in Biochemistry/Chemistry or related field
• 3+ 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

Nice To Haves

• Biopharmaceutical/Bioprocess filtration products and techniques

Responsibilities

• 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.

Benefits

• Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives.
• Whether it’s 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees