Manager of Quality Assurance and Regulatory Affairs Jobs in Chicago, IL
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.
Lab Manager - Microbiology, Biology and Chemistry
- River Forest, IL (8 miles from Chicago, IL)
- 3 days ago
- River Forest, IL (8 miles from Chicago, IL)
- 3 days ago
Concordia University Chicago (CUC) invites applications for the position of Laboratory Manager for Microbiology, Biology and Chemistry in the Department of Natural Sciences in the College of Health,...
Position Details Job Title LAB MANAGER Position Number 8150374 Job Category University Staff Job Type Full-Time FLSA Status Exempt Campus Maywood-Health Sciences Campus Department Name PHYSIOLOGY...
Department: MED-Ophthalmology Salary/Grade: EXS/8 Job Summary: Provides complex scientific & technical leadership in determining research priorities & the plan, design & execution of research...
Director Regulatory Affairs Alliance and Commercialization - Remote Opportunity
- Deerfield, IL (21 miles from Chicago, IL)
- 29 days ago
- Deerfield, IL (21 miles from Chicago, IL)
- 29 days ago
Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company...
Sr Director, Quality Assurance NAM
- Lincolnshire, IL (23 miles from Chicago, IL)
- 45+ days ago
- Lincolnshire, IL (23 miles from Chicago, IL)
- 45+ days ago
Company Description SGS is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality...
- Chicago, IL (9 miles from Chicago, IL)
- 45+ days ago
- Chicago, IL (9 miles from Chicago, IL)
- 45+ days ago
Department SSD Psychology: Staff and Temporary Employees About the Department The lab manager will be working under Professor Oishi, Department of Psychology, Social Sciences Division. Job Summary...
- Harvey, IL (20 miles from Chicago, IL)
- 90+ days ago
- Harvey, IL (20 miles from Chicago, IL)
- 90+ days ago
SUMMARY: Manages laboratory resources to ensure safe, regulatory compliance and expeditious processing of technical information and analysis in support of site objectives. Supervises and...
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Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in Chicago, IL 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
- Continuous Improvement
- Affirmative Action
- Quality Systems
- Implementation
- Quality Management
- Coaching
- Inspections
- Quality Management Systems
- Batch Record Review
- Internal Audits
- GxP
- TrackWise
- Institutional Review Board
- ICH GCP
- Spectrophotometer
- Gene Therapy
- Proteomics
- ICH Guidelines
- Lab Safety
- Neurobiology
- Clinical Laboratory Operations
- Biology
- Biochemistry
- Drug Development
- Immunology
- Microbiology
- Immunohistochemistry
- Experimental Design
- Biotechnology
- Scientific Writing
- Clinical Trials
- Laboratory Management
- Equipment Calibration
- Medical Device Sales
- Corrective Actions & Preventive Actions
- FDA Regulations
- Research and Development
- Good Manufacturing Practices
- Standard Operating Procedures
- Masters In Education
- Engineering
- Strategy Development
- Quality Control
- Auditing
- Investigation
- Written Communication
- Education Experience
- Quality Assurance
- Collaboration
- Documentation
- Reporting
- Bachelor's Degree
- Inventory Management
- Regulations
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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