Director of Quality Assurance and Regulatory Affairs Jobs in Utah
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.
Principal Scientist (Director) - Regulatory Affairs-CMC
- Salt Lake City, UT
- 4 days ago
- Salt Lake City, UT
- 4 days ago
Fields of study include Biology, Microbiology,or Biochemistry, Chemical, Mechanical and Electrical Engineering. **** **Required Experience and Skills:** + Demonstrated experience in a CMC regulatory...
Associate Principal Scientist/Associate Director , Regulatory Affairs - Compliance
- Salt Lake City, UT
- 8 days ago
- Salt Lake City, UT
- 8 days ago
This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility for this position is to ensure...
Associate Director, Regulatory Affairs
- Salt Lake City, UT
- 17 days ago
- Salt Lake City, UT
- 17 days ago
California, US residents click here (. **The job details are as follows:** **Who we are** We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit...
Overview The Gompert Lab at Utah State University (Department of Biology) is seeking a Lab Manager/Research Technician to join the team in Fall 2025....
We are the movers of the world and the makers of the future. We get up every day, roll up our sleeves and build a better world -- together. At Ford, were all a part of something bigger than...
Certified Group is a leading North American provider of laboratory testing, regulatory consulting, and certification & audit services. The Certified Group of companies includes Food Safety Net...
Job#: 2073658 Job Description: We are currently looking for a Lab Manager to join our growing team! JOB SUMMARY Responsible for overseeing laboratory operations and maintains direct contact with...
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Director of Quality Assurance and Regulatory Affairss in Utah 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
- Affirmative Action
- Quality Systems
- ISO Certified
- Implementation
- Hazardous Materials
- Quality Management
- Document Control
- Coaching
- Inspections
- ISO 13485
- Quality Management Systems
- Control Systems
- Batch Record Review
- GxP
- TrackWise
- Animal Models
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Molecular Biology
- Genotyping
- Drug Development
- Biochemistry
- Biology
- Immunology
- Microbiology
- Biotechnology
- Good Laboratory Practice
- Laboratory Management
- Equipment Calibration
- Medical Device Sales
- FDA Regulations
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Research and Development
- Process Development
- Masters In Education
- Engineering
- Strategy Development
- Auditing
- Investigation
- Written Communication
- Quality Assurance
- Collaboration
- Documentation
- Inventory Management
- Regulations
- Project Management
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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