Quality Regulatory Support Manager - Bioprocess
Cytiva Sweden AB / Administratörsjobb / Uppsala
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hela Sverige Be part of something altogether life-changing
Working at Cytiva in the Life Sciences industry 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. Your health and wellbeing are important to us and together we will not compromise on safety in the workplace or the environment.
Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we're pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
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.
Fluent in English and French (written and spoken).
Additional desired Qualifications:
Experience with biopharmaceutical process development and quality assurance.
Expertise in the medical regulatory field.
Experience leading cross-functional activities.
At Cytiva we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cytiva can provide.
When you join us, you'll also be joining Danaher's global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
At Danaher, 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.
If you've ever wondered what's within you, there's no better time to find out.
Så ansöker du Sista dag att ansöka är 2023-08-12
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Cytiva Sweden AB (org.nr 556108-1919)
Björkgatan 30 (
visa karta)
751 84 UPPSALA
Arbetsplats Cytiva Sverige AB
Jobbnummer 8004025
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