Director of Quality Assurance and Regulatory Affairs Jobs in Richardson, TX
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.
Posting Number S06449P Position Title Lab Manager Functional Title Department Speech Language Hearing Salary Range $65,000 - $70,000, DOQ Pay Basis Monthly Position Status Regular full-time...
Posting Number: S06449P Department: Speech Language Hearing Salary Range: $65,000 - $70,000, DOQ Pay Basis: Monthly Position Status: Regular full-time Location: Dallas Job Description: Join Our...
- Dallas, TX (12 miles from Richardson, TX)
- 7 days ago
- Dallas, TX (12 miles from Richardson, TX)
- 7 days ago
Join Our Team Lab Manager Position at the UT Larynx Lab Are you passionate about voice science and eager to make a meaningful contribution to cutting-edge research? The UT Larynx Lab, led by Dr....
- Frisco, TX (16 miles from Richardson, TX)
- 12 days ago
- Frisco, TX (16 miles from Richardson, TX)
- 12 days ago
Biology Spec-ASCP (SMB):....
Research Scientist (Lab Manager), CRI
- Dallas, TX (12 miles from Richardson, TX)
- 16 days ago
- Dallas, TX (12 miles from Richardson, TX)
- 16 days ago
Current studies employ molecular biology (PCRs, cloning), cell biology/biochemistry (Cell culture, protein work), animal models (mouse models; tumor xenografts, genotyping) combined with unbiased metabolomics...
Science Safety and Lab Manager
- Dallas, TX (12 miles from Richardson, TX)
- 90+ days ago
- Dallas, TX (12 miles from Richardson, TX)
- 90+ days ago
Qualifications: B.S. in Biology or a related scientific field is required; a Master of Science is preferred. Exceptional organizational skills and meticulous attention to detail....
Demographic Data for Richardson, TX
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Director of Quality Assurance and Regulatory Affairss in Richardson, TX 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
- Electrical Engineering
- 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
- Institutional Review Board
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Molecular Biology
- Genotyping
- Drug Development
- Biology
- Biochemistry
- Microbiology
- Biotechnology
- Good Laboratory Practice
- Laboratory Management
- Medical Device Sales
- Equipment Calibration
- FDA Regulations
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Research and Development
- Process Development
- Diagnostic
- Masters In Education
- Engineering
- Strategy Development
- Auditing
- 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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