Director of Quality Assurance and Regulatory Affairs Jobs in Harvey, 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.
SUMMARY: Manages laboratory resources to ensure safe, regulatory compliance and expeditious processing of technical information and analysis in support of site objectives. Supervises and...
- Chicago, IL (20 miles from Harvey, IL)
- 2 days ago
- Chicago, IL (20 miles from Harvey, IL)
- 2 days ago
Knowledge of research techniques or methods (cell biology, translation, transcription, primary cultures, microscopy, cell assays, biochemical assays, molecular biology assays)....
- Chicago, IL (20 miles from Harvey, IL)
- 6 days ago
- Chicago, IL (20 miles from Harvey, IL)
- 6 days 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...
Manager/Senior Manager, Regulatory Affairs
- Chicago, IL (20 miles from Harvey, IL)
- 6 days ago
- Chicago, IL (20 miles from Harvey, IL)
- 6 days ago
Clinical Practice, CAP/CLIA, other quality system standards Strong communication, presentation and interpersonal skills Experience leading cross-functional teams of subject matter experts Experience...
Remote Work- Chicago, IL (20 miles from Harvey, IL)
- 8 days ago
- Chicago, IL (20 miles from Harvey, IL)
- 8 days ago
Knowledge of research techniques or methods (cell biology, translation, transcription, primary cultures, microscopy, cell assays, biochemical assays, molecular biology assays)....
Lab Manager University of Chicago (UC)
- Chicago, IL (20 miles from Harvey, IL)
- 8 days ago
- Chicago, IL (20 miles from Harvey, IL)
- 8 days ago
Knowledge of research techniques or methods (cell biology, translation, transcription, primary cultures, microscopy, cell assays, biochemical assays, molecular biology assays)....
Associate/Director of Regulatory Affairs (remote U
- Chicago, IL (20 miles from Harvey, IL)
- 12 days ago
- Chicago, IL (20 miles from Harvey, IL)
- 12 days ago
at PAREXEL International LLC in Chicago, Illinois, United States Job Description Exciting opportunity to join Parexel as an Associate/Director of Regulatory Affairs! As an Associate/Director of...
Remote WorkResearch Lab Manager 1 - Parker Lab
- Chicago, IL (20 miles from Harvey, IL)
- 45+ days ago
- Chicago, IL (20 miles from Harvey, IL)
- 45+ days ago
Using an advanced level of skill, completes the following activities Molecular Biology: PCR Histology: Tissue fixation/processing: embedding, preparation of blocks and sectioning, staining Immunohistochemistry...
- Chicago, IL (20 miles from Harvey, IL)
- 60+ days ago
- Chicago, IL (20 miles from Harvey, IL)
- 60+ days ago
Performs biochemical, molecular biology, and cell biology experiments. Ensures project and laboratory compliance with different policies, procedures, directives, and mandates....
Demographic Data for Harvey, IL
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Highest Education Level
Director of Quality Assurance and Regulatory Affairss in Harvey, 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
- Safe Quality Food
- Interpersonal Skills
- Inspections
- Quality Management Systems
- Batch Record Review
- GxP
- Food Manufacturing
- 21 CFR 820
- Cell Biology
- Assay Development
- Real-Time Polymerase Chain Reaction
- Gene Therapy
- ICH Guidelines
- Genotyping
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Drug Discovery
- Pharmacovigilance
- Clinical Laboratory Operations
- DNA Isolation
- Drug Development
- Medical Writing
- Microbiology
- Biology
- Immunology
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Clinical Trials
- Biotechnology
- Laboratory Management
- Validation
- FDA Regulations
- Medical Device Sales
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Military Background
- Quality Control
- Investigation
- Auditing
- Written Communication
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Inventory Management
- Regulations
- Policy Development
- Project Management
- Research Skills
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Teamwork
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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