Director of Quality Assurance and Regulatory Affairs Jobs in North Chicago, IL
A Director of Quality Assurance and Regulatory Affairs in the biotechnology industry is essentially responsible for developing and implementing systems that ensure products meet quality standards and regulatory requirements. This includes conducting internal audits, leading investigations into quality issues, liaising with regulatory bodies, and overseeing the submission of regulatory documents. They are also responsible for ensuring compliance with regulatory requirements and standards such as ISO, FDA, and EMEA. They play a crucial role in maintaining the company's reputation and ensuring customer satisfaction by ensuring that products are safe, reliable, and meet both customer and regulatory requirements.
Key skills for this role include strong analytical and problem-solving skills, excellent communication skills, and a strong knowledge of the biotechnology industry and its associated regulations. They should also have strong leadership skills, as they will often be leading teams and coordinating with other departments. Important certifications may include Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Regulatory Affairs Certification (RAC), or Certified Quality Manager (CQM). Prior to becoming a Director of Quality Assurance and Regulatory Affairs, an individual may have roles such as Quality Assurance Manager, Regulatory Affairs Specialist, or Senior Quality Engineer within the industry.
Lab Manager - Culture, Diversity, and Inequality Lab
- Evanston, IL (20 miles from North Chicago, IL)
- 6 days ago
- Evanston, IL (20 miles from North Chicago, IL)
- 6 days ago
Department: Kellogg Mgt and Organizations Professor Nicole Stephens is seeking a full-time Lab Manager/ Research Assistant (38 hours/ week) for the Culture, Diversity, and Inequality Lab at the...
- Hawthorn Woods, IL (12 miles from North Chicago, IL)
- 30+ days ago
- Hawthorn Woods, IL (12 miles from North Chicago, IL)
- 30+ days ago
The Manager, Regulatory Affairs will be responsible for managing regulatory requirements and in-market product compliance to maintain and further develop the regulatory capability of the US-based...
Research Lab Manager 1 - Parker Lab
- Evanston, IL (20 miles from North Chicago, IL)
- 30+ days ago
- Evanston, IL (20 miles from North Chicago, IL)
- 30+ days ago
Using an advanced level of skill, completes the following activities Molecular Biology: PCR To view full details and how to apply, please login or create a Job Seeker account...
Sr. Director, Regulatory Affairs
- Lincolnshire, IL (9 miles from North Chicago, IL)
- 60+ days ago
- Lincolnshire, IL (9 miles from North Chicago, IL)
- 60+ 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 (9 miles from North Chicago, IL)
- 90+ days ago
- Lincolnshire, IL (9 miles from North 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 North Chicago, IL
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Salary for Director of Quality Assurance and Regulatory Affairs Jobs in North Chicago, IL
Highest Education Level
Director of Quality Assurance and Regulatory Affairss in North Chicago, IL offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Director of Quality Assurance and Regulatory Affairs position
- Quality Systems
- Supplier Management
- Implementation
- Interpersonal Skills
- Inspections
- Quality Management Systems
- Batch Record Review
- GxP
- Food Manufacturing
- 21 CFR 820
- Institutional Review Board
- Cell Biology
- Assay Development
- Transfection
- Real-Time Polymerase Chain Reaction
- Gene Therapy
- ICH Guidelines
- Genotyping
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Polymerase Chain Reaction
- Pharmacovigilance
- Clinical Laboratory Operations
- DNA Isolation
- Drug Development
- Medical Writing
- Biochemistry
- Microbiology
- Biology
- Stem Cells
- Immunology
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Biotechnology
- Laboratory Management
- Validation
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Quality Control
- Investigation
- Auditing
- Written Communication
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Education Experience
- Inventory Management
- Regulations
- Policy Development
- Project Management
- Research Skills
- Microsoft Office
- Problem Solving
- Teamwork
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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