Director of Quality Assurance and Regulatory Affairs Jobs in Santa Clara, 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.
Director, Regulatory Affairs CMC
- Foster City, CA (22 miles from Santa Clara, CA)
- 4 days ago
- Foster City, CA (22 miles from Santa Clara, CA)
- 4 days ago
At Gilead, were creating a healthier world for all people. For more than 35 years, weve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies...
Sr. Manager, Quality Assurance
- Milpitas, CA (8 miles from Santa Clara, CA)
- 6 days ago
- Milpitas, CA (8 miles from Santa Clara, CA)
- 6 days ago
Summary Responsible for quality of assigned BD Biosciences (BDB) New Product Development (NPD) medical devices products to ensure business objectives are met with regards to on time delivery of...
- San Carlos, CA (20 miles from Santa Clara, CA)
- 14 days ago
- San Carlos, CA (20 miles from Santa Clara, CA)
- 14 days ago
Manager, Quality Assurance in San Carlos, California Overview Manager, Quality Assurance W2 Contract-to-Hire Pay Rate: $60 - $65 per hour Location: San Carlos, CA - Hybrid Role Job Summary: We are...
- Palo Alto, CA (12 miles from Santa Clara, CA)
- 16 days ago
- Palo Alto, CA (12 miles from Santa Clara, CA)
- 16 days ago
Lab Manager Ford Motor Company - 4.1 Palo Alto, CA Job Details Estimated: $79.8K - $108K a year 23 hours ago Benefits Paid parental leave Paid holidays Visa sponsorship Health insurance Dental...
- Palo Alto, CA (12 miles from Santa Clara, CA)
- 19 days ago
- Palo Alto, CA (12 miles from Santa Clara, CA)
- 19 days ago
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...
Director, Regulatory Affairs - Job ID: DRA
- Palo Alto, CA (12 miles from Santa Clara, CA)
- 22 days ago
- Palo Alto, CA (12 miles from Santa Clara, CA)
- 22 days ago
Director, Regulatory Affairs - Job ID: DRA Ascendis Pharma - 4.8 Palo Alto, CA Job Details Full-time $225,000 - $240,000 a year 15 hours ago Benefits Paid parental leave Health savings account...
NVIDIA Silicon Solutions Group is seeking an engineering Lab Manager to join our team! In this role, you will manage hardware engineering labs, being responsible for all lab operations to support...
Associate Director, Regulatory Affairs - Global Labeling
- Foster City, CA (22 miles from Santa Clara, CA)
- 30+ days ago
- Foster City, CA (22 miles from Santa Clara, CA)
- 30+ days ago
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop...
Research Coordinator & Lab Manager @ 50% FTE (Remote Opportunity)
- Stanford, CA (12 miles from Santa Clara, CA)
- 45+ days ago
- Stanford, CA (12 miles from Santa Clara, CA)
- 45+ days ago
Stanford University is seeking a Research Coordinator & Lab Manager working remotely and required to go on-site 1 day or less per week. This position will perform duties related to data quality...
Regulatory Affairs Manager Vascular (on-site)
- Santa Clara, CA
- 60+ days ago
- Santa Clara, CA
- 60+ days ago
Preferred Qualifications Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields....
Associate Director, Regulatory Affairs
- Foster City, CA (22 miles from Santa Clara, CA)
- 90+ days ago
- Foster City, CA (22 miles from Santa Clara, CA)
- 90+ days ago
Support the Clinical Operation Team with Clinical Trial Applications. Leads the preparation and the critical review of submission documents to ensure compliance with regulatory requirements....
- Stanford, CA (12 miles from Santa Clara, CA)
- 90+ days ago
- Stanford, CA (12 miles from Santa Clara, CA)
- 90+ days ago
At least one year of research experience in molecular biology and cell culture, and proficiency in animal necropsy, tissue dissociation, flow cytometry, immunocytochemistry, tissue cryo-sectioning and...
Director / Senior Director, Regulatory Affairs
- Redwood City, CA (17 miles from Santa Clara, CA)
- 90+ days ago
- Redwood City, CA (17 miles from Santa Clara, CA)
- 90+ days ago
About Soleno Therapeutics Inc Soleno Therapeutics, Inc., based in Redwood City, California, is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare...
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Director of Quality Assurance and Regulatory Affairss in Santa Clara, 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
- 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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