Director of Quality Assurance and Regulatory Affairs Jobs in Pacheco, CA
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.
Senior Regulatory Affairs Manager APAC - Diabetes Care (on-site)
- Alameda, CA (15 miles from Pacheco, CA)
- 7 days ago
- Alameda, CA (15 miles from Pacheco, CA)
- 7 days ago
Preferred Qualifications Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields; Masters degree...
- San Francisco, CA (19 miles from Pacheco, CA)
- 10 days ago
- San Francisco, CA (19 miles from Pacheco, CA)
- 10 days ago
Adhere to a prescribed schedule for cleaning tissue culture rooms, including hoods, incubators, and water baths. Handle biohazard and chemical waste according to OSHA standards....
Senior Director, Regulatory Affairs (CMC)
- Brisbane, CA (24 miles from Pacheco, CA)
- 18 days ago
- Brisbane, CA (24 miles from Pacheco, CA)
- 18 days ago
Position Summary: Ultragenyx is seeking a highly motivated Senior Director, Regulatory Affairs CMC, who is a team builder and enjoys a fast-paced, dynamic work environment. In this position, the...
Senior Regulatory Affairs Manager Pacheco, California, United States Our Company Biocare Medical, LLC is an innovator in developing and supplying world class automated immunohistochemistry...
Regulatory Affairs Manager Canada & Latin America Diabetes Care (on-site)
- Alameda, CA (15 miles from Pacheco, CA)
- 27 days ago
- Alameda, CA (15 miles from Pacheco, CA)
- 27 days ago
Preferred Qualifications Bachelors degree in Biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology math, engineering, or medical fields....
Core Lab Manager University of California San Francisco
- San Francisco, CA (19 miles from Pacheco, CA)
- 30+ days ago
- San Francisco, CA (19 miles from Pacheco, CA)
- 30+ days ago
The Core Lab Manager provides daily operational management support for the Clinical Laboratory in assigned areas. Manages productivity, technical performance of specimen processing and laboratory...
- San Francisco, CA (19 miles from Pacheco, CA)
- 30+ days ago
- San Francisco, CA (19 miles from Pacheco, CA)
- 30+ days ago
The Core Lab Manager provides daily operational management support for the Clinical Laboratory in assigned areas. Manages productivity, technical performance of specimen processing and laboratory...
Commercial Regulatory Affairs Director
- Alameda, CA (15 miles from Pacheco, CA)
- 30+ days ago
- Alameda, CA (15 miles from Pacheco, CA)
- 30+ days ago
Reviews and approves clinical development communications and materials in support of Exelixis clinical trials, including site training slides and newsletters....
Sr. Director, Quality Assurance
- San Francisco, CA (19 miles from Pacheco, CA)
- 45+ days ago
- San Francisco, CA (19 miles from Pacheco, CA)
- 45+ days ago
With proof-of concept data in Guillain-Barre syndrome, Huntington's disease and geographic atrophy, we are rigorously advancing our mid-to late-stage clinical trials to bring new potential treatments...
Regulatory Affairs Manager APAC - Diabetes Care (on-site)
- Alameda, CA (15 miles from Pacheco, CA)
- 90+ days ago
- Alameda, CA (15 miles from Pacheco, CA)
- 90+ days ago
Preferred Qualifications Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields....
Demographic Data for Pacheco, CA
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Director of Quality Assurance and Regulatory Affairss in Pacheco, CA 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
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- Biotechnology
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- 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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