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.
Director, Regulatory Affairs Strategy
- Chicago, IL (20 miles from Harvey, IL)
- 1 day ago
- Chicago, IL (20 miles from Harvey, IL)
- 1 day ago
Location: REMOTE Salary: $190,000.00 USD Annually - $215,000.00 USD Annually Description: Our client is currently seeking a Director, Regulatory Affairs Strategy who will be responsible for...
- Chicago, IL (20 miles from Harvey, IL)
- 4 days ago
- Chicago, IL (20 miles from Harvey, IL)
- 4 days ago
developed through**Certifications:****\-\--****Preferred Qualifications****Education**- A bachelor\'s degree (or higher) in neuroscience, cognitive science, computer science, psychology, sociology, biology...
Manager/Senior Manager, Regulatory Affairs - CDx
- Chicago, IL (20 miles from Harvey, IL)
- 13 days ago
- Chicago, IL (20 miles from Harvey, IL)
- 13 days ago
Minimum of 5+ years of experience in Regulatory Affairs experience related to medical devices Knowledge of engineering concepts and biology with ability to evaluate device performance data and develop...
Remote Work- Chicago, IL (20 miles from Harvey, IL)
- 15 days ago
- Chicago, IL (20 miles from Harvey, IL)
- 15 days ago
Department BSD CCC - CCT Pod1 About the Department The University of Chicago Comprehensive Cancer Center (UCCCC) is an integral component of the Biological Sciences Division (BSD). The BSD is the...
Regulatory Affairs Manager (Regulatory Systems Specialist)
- Chicago, IL (20 miles from Harvey, IL)
- 15 days ago
- Chicago, IL (20 miles from Harvey, IL)
- 15 days ago
Regulatory Affairs Manager II 12 Month Contract | REMOTE Join a leading biopharma company supporting critical regulatory systems initiatives. We're seeking a detail-oriented consultant with...
Regulatory Affairs Manager - JR29338-3800
- Chicago, IL (20 miles from Harvey, IL)
- 15 days ago
- Chicago, IL (20 miles from Harvey, IL)
- 15 days ago
The University of Chicago Regulatory Affairs Manager - JR29338-3800 in Chicago , Illinois This job was posted by : For more information, please see: Department BSD CCC - CCT Pod1 About the...
- Chicago, IL (20 miles from Harvey, IL)
- 19 days ago
- Chicago, IL (20 miles from Harvey, IL)
- 19 days ago
Regulatory Affairs Manager II#25-53978 Chicago, IL Fully Remote Job Description 100% Remote (EST time zone) 12 months *** per hour max bill rate Performs eCTD submission management across ***'s...
Remote WorkManager, Regulatory Affairs - Advertising & Promotion
- Chicago, IL (20 miles from Harvey, IL)
- 28 days ago
- Chicago, IL (20 miles from Harvey, IL)
- 28 days ago
Overview The Manager, Regulatory Affairs role is responsible for creating the FDA submission package for promotional material in Veeva PromoMats, and for general system administration and...
- Chicago, IL (20 miles from Harvey, IL)
- 30+ days ago
- Chicago, IL (20 miles from Harvey, IL)
- 30+ days ago
Knowledge of research techniques or methods (cell biology, translation, transcription, primary cultures, microscopy, cell assays, biochemical assays, molecular biology assays)....
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)
- 30+ days ago
- Chicago, IL (20 miles from Harvey, IL)
- 30+ 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...
Lab Manager University of Chicago (UC)
- Chicago, IL (20 miles from Harvey, IL)
- 30+ days ago
- Chicago, IL (20 miles from Harvey, IL)
- 30+ days ago
Knowledge of research techniques or methods (cell biology, translation, transcription, primary cultures, microscopy, cell assays, biochemical assays, molecular biology assays)....
Demographic Data for Harvey, IL
Moving to Harvey, IL? Find some basic demographic data about Harvey, IL below.
Director of Quality Assurance and Regulatory Affairs Online Courses and Training Opportunities
Title Synonyms
Users interested in this job title also searched for the following job titles
Salary for Director of Quality Assurance and Regulatory Affairs Jobs in Harvey, IL
Required or preferred licenses and certifications for Director of Quality Assurance and Regulatory Affairs positions.
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
- Mentoring
- Quality Systems
- Implementation
- Change Control
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- 21 CFR 820
- Institutional Review Board
- Assay Development
- Flow Cytometry
- Good Clinical Practice
- Real-Time Polymerase Chain Reaction
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Genotyping
- Lab Safety
- Molecular Biology
- Transfection
- Cloning
- Clinical Laboratory Operations
- Cancer Biology
- Polymerase Chain Reaction
- Western Blot
- DNA Isolation
- Drug Development
- Biology
- Medical Writing
- Pharmacovigilance
- Stem Cells
- Microbiology
- Microscopy
- Good Laboratory Practice
- Scientific Writing
- Biotechnology
- Laboratory Management
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Collections
- Quality Control
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Reporting
- Education Experience
- Bachelor's Degree
- Inventory Management
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
Other Career Titles
Here are some other career titles that require similar skills
Director of Quality Assurance and Regulatory Affairs Related Career Advice Articles
4 Biotech Opportunities & Career Paths With High Growth Potential
Biotechnology is an emerging segment of the employment market with opportunities spanning healthcare, biopharmaceuticals, agriculture, industry, and academia. If you have a thirst for innovation, this career path might be right for you!
Read article »