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.
- Chicago Ridge, IL (14 miles from Chicago, IL)
- 17 hours ago
- Chicago Ridge, IL (14 miles from Chicago, IL)
- 17 hours ago
Medical Laboratory Manager Schedule: Monday-Friday, one weekend per month One night per week, holiday rotation This rural Minnesota hospital is committed to providing high-quality, personalized...
Location: REMOTE Salary: $190,000.00 USD Annually - $215,000.00 USD Annually Description: Our client is currently seeking a Director, Regulatory Affairs Strategy who will be responsible for...
developed through**Certifications:****\-\--****Preferred Qualifications****Education**- A bachelor\'s degree (or higher) in neuroscience, cognitive science, computer science, psychology, sociology, biology...
Minimum of 5+ years of experience in Regulatory Affairs experience related to medical devices Knowledge of engineering concepts and biology with ability to evaluate device performance data and develop...
Remote Work/23013/26005acc-7f4a-4e46-9872-b02b7c2cfb23.gif&z=8&s=BIO&ih_t=4%2F21%2F2025+4%3A01%3A58+AM&utm_medium=internal%20referrer&utm_campaign=affiliate_nw_msha&utm_content=northwestern&utm_term=sf_serp_searchresults_position_5&dt=Desktop)
Department BSD CCC - CCT Pod1 About the Department The University of Chicago Comprehensive Cancer Center (UCCCC) is an integral component of the Biological Sciences Division (BSD). The BSD is the...
Regulatory Affairs Manager (Regulatory Systems Specialist)
- Chicago, IL
- 20 days ago
- Chicago, IL
- 20 days ago
Regulatory Affairs Manager II 12 Month Contract | REMOTE Join a leading biopharma company supporting critical regulatory systems initiatives. We're seeking a detail-oriented consultant with...
The University of Chicago Regulatory Affairs Manager - JR29338-3800 in Chicago , Illinois This job was posted by : For more information, please see: Department BSD CCC - CCT Pod1 About the...
Regulatory Affairs Manager II#25-53978 Chicago, IL Fully Remote Job Description 100% Remote (EST time zone) 12 months *** per hour max bill rate Performs eCTD submission management across ***'s...
Remote WorkManager, Regulatory Affairs - Advertising & Promotion
- Chicago, IL
- 30+ days ago
- Chicago, IL
- 30+ days ago
Overview The Manager, Regulatory Affairs role is responsible for creating the FDA submission package for promotional material in Veeva PromoMats, and for general system administration and...
- Harvey, IL (20 miles from Chicago, IL)
- 30+ days ago
- Harvey, IL (20 miles from Chicago, IL)
- 30+ 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...
Medical Laboratory Manager Schedule: Monday-Friday, one weekend per month One night per week, holiday rotation This rural Minnesota hospital is committed to providing high-quality, personalized...
Sr. Director, Regulatory Affairs
- Lincolnshire, IL (23 miles from Chicago, IL)
- 90+ days ago
- Lincolnshire, IL (23 miles from Chicago, IL)
- 90+ days ago
Overview Find a Better Way... ...to use your skills and experience. This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the...
- Lincolnshire, IL (23 miles from Chicago, IL)
- 90+ days ago
- Lincolnshire, IL (23 miles from Chicago, IL)
- 90+ days ago
Overview Find a Better Way... ...to use your skills and experience. This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the...
Demographic Data for Chicago, IL
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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
- Affirmative Action
- Quality Systems
- Implementation
- Resolution
- Change Control
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- ASQ Certified Quality Auditor
- TrackWise
- 21 CFR 820
- Institutional Review Board
- Assay Development
- Good Clinical Practice
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Genotyping
- Lab Safety
- Molecular Biology
- Clinical Laboratory Operations
- Polymerase Chain Reaction
- Western Blot
- DNA Isolation
- Bioinformatics
- Drug Development
- Biology
- Medical Writing
- Pharmacovigilance
- Stem Cells
- Microbiology
- Good Laboratory Practice
- Scientific Writing
- Biotechnology
- Clinical Trials
- Laboratory Management
- FDA Regulations
- Medical Device Sales
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Control
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Reporting
- Education Experience
- Bachelor's Degree
- Inventory Management
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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