Director of Quality Assurance and Regulatory Affairs Jobs in Illinois
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...
Knowledge of research techniques or methods (cell biology, translation, transcription, primary cultures, microscopy, cell assays, biochemical assays, molecular biology assays)....
Research Lab Manager - Coordinated Science Lab Coordinated Science Lab The Health Care Engineering Systems Center(HCESC) at the Coordinated Science Laboratory in the Grainger College ofEngineering...
Lab Manager - Culture, Diversity, and Inequality Lab
- Evanston, IL
- 3 days ago
- Evanston, IL
- 3 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...
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...
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 WorkKnowledge of research techniques or methods (cell biology, translation, transcription, primary cultures, microscopy, cell assays, biochemical assays, molecular biology assays)....
Knowledge of research techniques or methods (cell biology, translation, transcription, primary cultures, microscopy, cell assays, biochemical assays, molecular biology assays)....
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 WorkSenior Manager, Regulatory Affairs (Strategy and CMC)
- Lake Zurich, IL
- 13 days ago
- Lake Zurich, IL
- 13 days ago
Job Summary The Senior Manager, Regulatory Affairs (Strategy and CMC) delivers regulatory guidance which includes strategic and CMC input in Biosimilar Development and Life Cycle Management to...
Description The Lab of Manager Operations - Histology reflects the mission, vision, and values of NM, adheres to the organizations Code of Ethics and Corporate Compliance Program, and complies...
Associate Director, Quality Assurance - Remote
- Springfield, IL
- 28 days ago
- Springfield, IL
- 28 days ago
Associate Director, Quality Assurance - Remote Company: Merck Location: Springfield, IL Date Posted: 2/12/25, 2:27 AM Job Description Reporting to the Director of Medical Device and Combination...
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...
- North Chicago, IL
- 30+ days ago
- North Chicago, IL
- 30+ 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...
Manager, Regulatory Affairs US Advertising & Promotion, Oncology
- North Chicago, IL
- 30+ days ago
- North Chicago, IL
- 30+ days 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...
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Director of Quality Assurance and Regulatory Affairss in Illinois 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
- English
- Quality Systems
- Supplier Management
- Distribution
- Implementation
- Resolution
- Safe Quality Food
- Coaching
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- Food Manufacturing
- 21 CFR 820
- 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
- FDA Regulations
- Medical Device Sales
- Good Manufacturing Practices
- Corrective Actions & Preventive Actions
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Military Background
- Troubleshooting
- Quality Control
- Investigation
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Inventory Management
- Regulations
- Teaching
- Policy Development
- Project Management
- Research Skills
- Microsoft Office
- Problem Solving
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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