Regulatory & Quality Compliance Manager - Lifelancer
Knoxville, TN
About the Job
Job Title: Regulatory & Quality Compliance Manager (m/f/d)
Job Location: Knoxville, TN, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
The internal Job Title is called Global Product Center Manager (m/f/d) - Sterile Fluids (Medicinal Products).
Main Responsibilities:
There is a lot for you to discover at Fresenius, because we have a lot to offer. No matter in which field you are an expert (m/f/d) and how much experience you bring with you - for your professional future with meaning:
Main Responsibilities:
- Support as regulatory expert development and new registration projects (Medicinal Products)
- Project management for the implementation of projects to comply with regulatory requirements
- Organization of submission-readiness of regulatory documentation (e.g., CMC relevant parts)
- Organize and support global creation and maintenance of regulatory documentation
- Management of global teams within change projects
- Expert and interface function to the development department, marketing, production, quality department, as well as to the regional/local approval unit
- International coordination and communication in a global organization
- Successfully completed technical or scientific studies
- Experience in project management respectively change control process
- Experience in regulatory affairs or in a quality environment, ideally in a pharmaceutical/medical environment of advantage
- Knowledgeable in relevant regulations (such as registration of medicinal products, change control, GxP, EU requirements, CMC, ICH M4, etc.)
- Language requirements: Fluent in English, advanced in German
- Structured and independent way of working
- Strong communication skills
- Ability to work in and with a team
- Assertiveness
There is a lot for you to discover at Fresenius, because we have a lot to offer. No matter in which field you are an expert (m/f/d) and how much experience you bring with you - for your professional future with meaning:
- The opportunity to work on a mobile basis
- Whether in front of or behind the scenes - you will help to make better and better medicine available to more and more people around the world
- Individual opportunities for self-determined career planning and professional development
- A corporate culture in which there is enough room for innovative thinking - to find the best, not the fastest, solution together
- A large number of committed people with a wide range of skills, talents and experience
- The benefits of a successful global corporation with the collegial culture of a medium-sized company
- Supporting the department in cross-site activities to monitor product quality and regulatory compliance
Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
For more details and to find similar roles, please check out the below Lifelancer link.
https://lifelancer.com/jobs/view/b7622fd91f2e7246c2ce800c3480f6f4
Source : Lifelancer