Director of Quality Assurance and Regulatory Affairs Jobs in Lincolnshire, 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.
- Chicago, IL (23 miles from Lincolnshire, IL)
- 2 days ago
- Chicago, IL (23 miles from Lincolnshire, IL)
- 2 days ago
Knowledge of research techniques or methods (cell biology, translation, transcription, primary cultures, microscopy, cell assays, biochemical assays, molecular biology assays)....
Lab Manager - Culture, Diversity, and Inequality Lab
- Evanston, IL (14 miles from Lincolnshire, IL)
- 3 days ago
- Evanston, IL (14 miles from Lincolnshire, 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...
- Chicago, IL (23 miles from Lincolnshire, IL)
- 6 days ago
- Chicago, IL (23 miles from Lincolnshire, 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 (23 miles from Lincolnshire, IL)
- 6 days ago
- Chicago, IL (23 miles from Lincolnshire, 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 (23 miles from Lincolnshire, IL)
- 8 days ago
- Chicago, IL (23 miles from Lincolnshire, 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 (23 miles from Lincolnshire, IL)
- 8 days ago
- Chicago, IL (23 miles from Lincolnshire, 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 (23 miles from Lincolnshire, IL)
- 12 days ago
- Chicago, IL (23 miles from Lincolnshire, 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 WorkSenior Manager, Regulatory Affairs (Strategy and CMC)
- Lake Zurich, IL (6 miles from Lincolnshire, IL)
- 13 days ago
- Lake Zurich, IL (6 miles from Lincolnshire, 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...
Lab Manager Operations - Histology
- Winfield, IL (24 miles from Lincolnshire, IL)
- 17 days ago
- Winfield, IL (24 miles from Lincolnshire, IL)
- 17 days ago
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...
- Hawthorn Woods, IL (6 miles from Lincolnshire, IL)
- 30+ days ago
- Hawthorn Woods, IL (6 miles from Lincolnshire, 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...
- North Chicago, IL (9 miles from Lincolnshire, IL)
- 30+ days ago
- North Chicago, IL (9 miles from Lincolnshire, 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 (9 miles from Lincolnshire, IL)
- 30+ days ago
- North Chicago, IL (9 miles from Lincolnshire, 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...
Research Lab Manager 1 - Parker Lab
- Evanston, IL (14 miles from Lincolnshire, IL)
- 30+ days ago
- Evanston, IL (14 miles from Lincolnshire, 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...
Future Opportunities - Join Our Talent Pipeline for Director Regulatory Affairs, Global Regulatory
- North Chicago, IL (9 miles from Lincolnshire, IL)
- 45+ days ago
- North Chicago, IL (9 miles from Lincolnshire, IL)
- 45+ 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...
- Chicago, IL (23 miles from Lincolnshire, IL)
- 60+ days ago
- Chicago, IL (23 miles from Lincolnshire, 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 Lincolnshire, IL
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Salary for Director of Quality Assurance and Regulatory Affairs Jobs in Lincolnshire, IL
Highest Education Level
Director of Quality Assurance and Regulatory Affairss in Lincolnshire, 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
- Assay Development
- Transfection
- 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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