Director of Quality Assurance and Regulatory Affairs Jobs in Mettawa, 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.
Senior Manager Regulatory Affairs US Advertising and Promotion - Immunology - Dermatology
- Mettawa, IL
- 2 hours ago
- Mettawa, IL
- 2 hours ago
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive...
- Golf, IL (13 miles from Mettawa, IL)
- 16 hours ago
- Golf, IL (13 miles from Mettawa, IL)
- 16 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...
- Russell, IL (17 miles from Mettawa, IL)
- 16 hours ago
- Russell, IL (17 miles from Mettawa, IL)
- 16 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...
Lab Manager- Quality Control/Microbiology
- Mundelein, IL (9 miles from Mettawa, IL)
- 15 days ago
- Mundelein, IL (9 miles from Mettawa, IL)
- 15 days ago
Job Summary Responsible for managing daily laboratory operations and staff (Chemistry, Microbiology, or Material Science). Job Description Responsibilities: Manage day to day activities. Ensure...
Manager, Regulatory Affairs US Advertising and Promotion - Immunology
- Mettawa, IL
- 20 days ago
- Mettawa, IL
- 20 days ago
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable...
Sr. Director, Regulatory Affairs
- Lincolnshire, IL (4 miles from Mettawa, IL)
- 90+ days ago
- Lincolnshire, IL (4 miles from Mettawa, 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 Mettawa, IL
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Required or preferred licenses and certifications for Director of Quality Assurance and Regulatory Affairs positions.
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Director of Quality Assurance and Regulatory Affairss in Mettawa, 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
- Verbal Communication
- Mentoring
- Quality Systems
- Implementation
- Change Control
- Coaching
- Quality Management Systems
- Batch Record Review
- GxP
- 21 CFR 820
- Assay Development
- Biomarkers
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Genotyping
- Next-Generation Sequencing
- Lab Safety
- Molecular Biology
- Cloning
- Clinical Laboratory Operations
- Polymerase Chain Reaction
- DNA Isolation
- Drug Development
- Western Blot
- Biology
- Stem Cells
- Microbiology
- Biotechnology
- Clinical Trials
- Good Laboratory Practice
- Clinical Research
- Laboratory Management
- Neurology
- Oncology
- FDA Regulations
- Research and Development
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Control
- Military Background
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Interpersonal Skills
- Bachelor's Degree
- Reporting
- Education Experience
- Regulations
- Policy Development
- Problem Solving
- Research Skills
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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