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, Quality & Regulatory Compliance
- Chicago, IL (20 miles from Harvey, IL)
- 4 days ago
- Chicago, IL (20 miles from Harvey, IL)
- 4 days ago
Menasha Corporation Employees, please log-in to your Workday account to apply for positions. ABOUT US (AND OUR EXCITING FUTURE) Menasha Corporation is all about possibilities. Our two businesses,...
- Cicero, IL (16 miles from Harvey, IL)
- 7 days ago
- Cicero, IL (16 miles from Harvey, IL)
- 7 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 - CDx
- Chicago, IL (20 miles from Harvey, IL)
- 28 days ago
- Chicago, IL (20 miles from Harvey, IL)
- 28 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)
- 30+ days ago
- Chicago, IL (20 miles from Harvey, IL)
- 30+ 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 - JR29338-3800
- Chicago, IL (20 miles from Harvey, IL)
- 30+ days ago
- Chicago, IL (20 miles from Harvey, IL)
- 30+ 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)
- 30+ days ago
- Chicago, IL (20 miles from Harvey, IL)
- 30+ 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)
- 30+ days ago
- Chicago, IL (20 miles from Harvey, IL)
- 30+ 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)
- 45+ days ago
- Chicago, IL (20 miles from Harvey, IL)
- 45+ days ago
Department SSD: Psychology: Staff and Temporary Employees-Woodward Lab About the Department The researchers in the Center for Early Childhood Research use innovative and varied methods to...
SUMMARY: Manages laboratory resources to ensure safe, regulatory compliance and expeditious processing of technical information and analysis in support of site objectives. Supervises and...
Demographic Data for Harvey, IL
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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
- Verbal Communication
- Mentoring
- Quality Systems
- Implementation
- Change Control
- Coaching
- Quality Management Systems
- Batch Record Review
- GxP
- 21 CFR 820
- Assay Development
- Biomarkers
- Flow Cytometry
- 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
- 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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