Manager of Quality Assurance and Regulatory Affairs Jobs in Minnesota
A Manager of Quality Assurance and Regulatory Affairs in the biotechnology industry is responsible for ensuring that all products and services meet required standards and regulations. They ensure compliance with local, national, and international regulatory requirements, oversee quality control processes, and manage audits and inspections. This role also involves creating and implementing policies and procedures to enhance product quality, efficiency, and safety. They also play a crucial role in the product development process, advising on regulatory requirements and ensuring that compliance is maintained throughout the lifecycle of a product.
Skills required for this role include excellent attention to detail, strong organizational and leadership skills, and in-depth knowledge of regulatory standards and quality control methods. In addition, they should have excellent problem-solving skills, the ability to work under pressure, and strong communication skills. They should also have a strong understanding of biotechnology principles and processes. Certifications such as Certified Quality Auditor (CQA), Certified Quality Manager (CQM), or Regulatory Affairs Certification (RAC) are often required. Prior roles that can lead to a Manager of Quality Assurance and Regulatory Affairs include Quality Assurance Specialist, Regulatory Affairs Associate, and Quality Control Supervisor.
Principal Scientist (Director) - Regulatory Affairs-CMC
- Saint Paul, MN
- 5 days ago
- Saint Paul, MN
- 5 days ago
Fields of study include Biology, Microbiology,or Biochemistry, Chemical, Mechanical and Electrical Engineering. **** **Required Experience and Skills:** + Demonstrated experience in a CMC regulatory...
Associate Principal Scientist/Associate Director , Regulatory Affairs - Compliance
- Saint Paul, MN
- 9 days ago
- Saint Paul, MN
- 9 days ago
This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility for this position is to ensure...
Apply for Job Job ID365859 LocationTwin Cities Job FamilyResearch Full/Part TimeFull-Time Regular/TemporaryRegular Job Code8353LS Employee ClassCivil Service Add to Favorite Jobs Email this Job...
Regulatory Affairs Manager - Electrophysiology (on-site)
- Plymouth, MN
- 30+ days ago
- Plymouth, MN
- 30+ days ago
Preferred Qualifications Bachelor's degree in science (biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology); math; engineering; or medical fields....
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Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in Minnesota offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Quality Assurance and Regulatory Affairs position
- Mentoring
- Employee Development
- Affirmative Action
- Quality Systems
- ISO Certified
- Implementation
- Hazardous Materials
- Quality Management
- Document Control
- Coaching
- Inspections
- ISO 13485
- Quality Management Systems
- Control Systems
- Batch Record Review
- GxP
- TrackWise
- Animal Models
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Molecular Biology
- Genotyping
- Biology
- Drug Development
- Biochemistry
- Immunology
- Microbiology
- Biotechnology
- Good Laboratory Practice
- Laboratory Management
- Equipment Calibration
- Medical Device Sales
- FDA Regulations
- Corrective Actions & Preventive Actions
- Research and Development
- Good Manufacturing Practices
- Process Development
- Masters In Education
- Engineering
- Strategy Development
- Auditing
- Investigation
- Written Communication
- Quality Assurance
- Collaboration
- Documentation
- Inventory Management
- Regulations
- Project Management
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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