Danaher Corporation Quality Regulatory Support Manager - Bioprocess in Marlborough, Massachusetts
Help us improve access to life-changing therapies that can transform human health
We are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020.
Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services - the pots, pans, soups and sauces - they need to work better, faster and safer, leading to better patient outcomes.
What you’ll do
The Regulatory Support Manager will have responsibility for supporting Product Managers, Regions and customers by providing quality documents and regulatory support in response to customers’ requests for quality, regulatory and technical-related information. Responsibilities will also include providing regulatory support in ongoing projects, product care activities, and change control. As a member of the Customer Regulatory Support team, you will add value to biopharmaceutical customers’ single-use products and demonstrate a commitment to customer satisfaction.
Build and maintain knowledge and understanding of customers’ regulatory requirements related to the BioProcess business at a high level
Develop and update regulatory support documentation for products in customers’ regulated environments
Perform necessary investigations and prepare and deliver statements and certificates
Participate in creating and updating guidelines and steering documents
Act as regulatory support expert and discussion partner to R&D, QA, Product Management and other functions and regions
Contribute in project teams as regulatory support expert
Participate in change control activities, including writing and releasing formal change control notifications
Lead cross-functional activities when required
Respond efficiently and promptly to customers’ regulatory based issues, which will include necessary investigations, preparations and delivery of certificates, use of internal and external databases
Prepare, update and review regulatory support documentation, including Validation Guides, change control notifications, statements, certificates and other regulatory related documentation for new and existing products
Use existing web based system and expand regulatory supporting information provided on the web
Who you are
Bachelor of Science degree in Chemistry, Pharmacy or related field
Three or more years of experience in quality, product management or a related field
Understanding of GMP and knowledge of regulatory requirements in the BioProcess industry
Organized, accurate, target oriented, quality minded and customer oriented
Strong written and verbal communication skills
Flexible and service-minded with the ability to be collaborative
Driven with strong ability to work independently
Additional desired Qualifications:
Experience with biopharmaceutical process development and quality assurance
Expertise in the medical regulatory field
Experience leading cross-functional activities
Who we are
Whatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you’ll feel right at home here. If you’re flexible, curious and relentless, you’ll belong. If you are excited about a global culture, this can be the place to further your career.
Want to know more? Take a look at our Instagram, Twitter and LinkedIn pages!
Cytiva is a 3.5 billion USD global life sciences leader with over 7000 associates across 40 countries who are dedicated to our mission to help us improve access to life-changing therapies that transform human health. As a trusted partner to customers that range in scale and scope, Cytiva brings efficiencies to research and manufacturing workflows, ensuring the development, manufacture and delivery of transformative medicines to patients.
As part of the Danaher family of companies, our work at Cytiva is supported by a global science and technology innovator. In addition to Danaher’s unrivaled leadership training and professional development programs, our relationship also provides expanded career opportunities across industries and brands. Together, we are united by a shared purpose: Helping Realize Life’s Potential.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.