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 Assurance (GCP)
- Chicago, IL (20 miles from Harvey, IL)
- 2 days ago
- Chicago, IL (20 miles from Harvey, IL)
- 2 days ago
years relevant clinical research experience in a combination of research site, biotech or pharma, or CRO experience Oncology clinical trials or oncology clinical experience Extensive knowledge of ICH...
Research Analyst II/Lab Manager - JR31002-3800
- Chicago, IL (20 miles from Harvey, IL)
- 15 days ago
- Chicago, IL (20 miles from Harvey, IL)
- 15 days ago
Train undergraduate researchers and paid assistants in Clytia husbandry and cell biology/molecular techniques....
- Chicago, IL (20 miles from Harvey, IL)
- 15 days ago
- Chicago, IL (20 miles from Harvey, IL)
- 15 days ago
at University of Chicago in Chicago, Illinois, United States Job Description Department SSD Psychology: Staff and Temporary Employees About the Department The lab manager will be working under...
Lab Manager - Pediatric Oncology Translational Research Lab
- Chicago, IL (20 miles from Harvey, IL)
- 26 days ago
- Chicago, IL (20 miles from Harvey, IL)
- 26 days ago
This would include sample accessioning (intake and processing), cell culture and other biochemical assays....
Senior Manager Regulatory Affairs, CMC and Regulatory Sciences
- Chicago, IL (20 miles from Harvey, IL)
- 27 days ago
- Chicago, IL (20 miles from Harvey, IL)
- 27 days ago
Description Senior Manager Regulatory Affairs - CMC CMC, and Regulatory Sciences About Us: Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of...
- Chicago, IL (20 miles from Harvey, IL)
- 45+ days ago
- Chicago, IL (20 miles from Harvey, IL)
- 45+ days ago
Department: MED-Ophthalmology Salary/Grade: EXS/8 Job Summary: Provides complex scientific & technical leadership in determining research priorities & the plan, design & execution of research...
- Chicago, IL (12 miles from Harvey, IL)
- 90+ days ago
- Chicago, IL (12 miles from Harvey, IL)
- 90+ days ago
Department SSD Psychology: Staff and Temporary Employees About the Department The lab manager will be working under Professor Oishi, Department of Psychology, Social Sciences Division. Job Summary...
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
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
- Inspections
- ISO 13485
- Quality Management Systems
- Batch Record Review
- GxP
- ICH GCP
- Assay Development
- Institutional Review Board
- Animal Models
- Spectrophotometer
- Cancer Research
- Gene Therapy
- Lab Safety
- Molecular Biology
- ICH Guidelines
- Medical Affairs
- Next-Generation Sequencing
- Clinical Laboratory Operations
- Water Testing
- Biology
- Scientific Research
- Microbiology
- Drug Development
- Pharmacovigilance
- Immunology
- Medical Writing
- Experimental Design
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Clinical Research
- Laboratory Management
- Medical Device Sales
- Good Manufacturing Practices
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Collections
- Strategy Development
- Quality Control
- Auditing
- Documentation
- Education Experience
- Investigation
- Collaboration
- Reporting
- Quality Assurance
- Inventory Management
- Interpersonal Skills
- Bachelor's Degree
- Policy Development
- Project Management
- Regulations
- Problem Solving
- Research Skills
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- 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 »