Director of Quality Assurance and Regulatory Affairs Jobs in Santa Clara, CA
Regulatory Affairs Manager Heart Failure (on-site)
- Pleasanton, CA (21 miles from Santa Clara, CA)
- 4 days ago
- Pleasanton, CA (21 miles from Santa Clara, CA)
- 4 days ago
Preferred Qualifications Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields....
- Redwood City, CA (17 miles from Santa Clara, CA)
- 10 days ago
- Redwood City, CA (17 miles from Santa Clara, CA)
- 10 days ago
Director, Regulatory Affairs in Redwood City, California Overview Director, Regulatory Affairs W2 Contract-to-Hire Salary Range: $218,400 - $239,200 per year Location: Redwood City, CA - Hybrid...
Associate Director, Regulatory Affairs - Oncology
- Foster City, CA (22 miles from Santa Clara, CA)
- 12 days ago
- Foster City, CA (22 miles from Santa Clara, CA)
- 12 days ago
Responsible for submitting complex regulatory documents including safety reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations original INDs...
- Foster City, CA (22 miles from Santa Clara, CA)
- 12 days ago
- Foster City, CA (22 miles from Santa Clara, CA)
- 12 days ago
Responsible for submissions which may include safety reports, amendments, supplements and license renewals to clinical trial applications (e.g....
Associate Director, Regulatory Affairs
- Redwood City, CA (17 miles from Santa Clara, CA)
- 14 days ago
- Redwood City, CA (17 miles from Santa Clara, CA)
- 14 days ago
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline...
Sr Manager, Quality Assurance - Global Supplier Quality (Biologics)
- Foster City, CA (22 miles from Santa Clara, CA)
- 22 days ago
- Foster City, CA (22 miles from Santa Clara, CA)
- 22 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...
- Newark, CA (12 miles from Santa Clara, CA)
- 30+ days ago
- Newark, CA (12 miles from Santa Clara, CA)
- 30+ days ago
Preferred Qualifications: Bachelor's degree in Chemistry, Biology, Pharmaceutical Science or a related field....
Senior Regulatory Affairs Manager - Oncology
- Palo Alto, CA (12 miles from Santa Clara, CA)
- 30+ days ago
- Palo Alto, CA (12 miles from Santa Clara, CA)
- 30+ days ago
Company Description Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is...
Senior Regulatory Affairs Manager - Screening
- Palo Alto, CA (12 miles from Santa Clara, CA)
- 30+ days ago
- Palo Alto, CA (12 miles from Santa Clara, CA)
- 30+ days ago
Company Description Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is...
Senior Regulatory Affairs Manager
- Palo Alto, CA (12 miles from Santa Clara, CA)
- 30+ days ago
- Palo Alto, CA (12 miles from Santa Clara, CA)
- 30+ days ago
Company Description Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is...
Director/Senior Director, Regulatory Affairs Strategy
- Menlo Park, CA (14 miles from Santa Clara, CA)
- 30+ days ago
- Menlo Park, CA (14 miles from Santa Clara, CA)
- 30+ days ago
and directly interfacing with US and international regulatory authorities Product development in therapeutic areas of dermatology, immunology or inflammation a plus Skills In depth knowledge of GXP/ICH...
Exec Director, Regulatory Affairs-Combination Products & Devices
- Foster City, CA (22 miles from Santa Clara, CA)
- 30+ days ago
- Foster City, CA (22 miles from Santa Clara, CA)
- 30+ days ago
In-depth understanding of ICH guidelines and GMP requirements for development and manufacturing of small molecules and biologics....
Senior Manager Regulatory Affairs - Global Regulatory Services
- Santa Clara, CA
- 30+ days ago
- Santa Clara, CA
- 30+ 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 - Global Regulatory Services
- Santa Clara, CA
- 30+ days ago
- Santa Clara, CA
- 30+ days ago
Preferred Qualifications Bachelor's degree in science (biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology); math; engineering; or medical fields....
- Sunnyvale, CA (4 miles from Santa Clara, CA)
- 30+ days ago
- Sunnyvale, CA (4 miles from Santa Clara, CA)
- 30+ days ago
Ensure that all processes contributing to the performance of a clinical trial are conducted properly....
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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
- Molecular Cloning
- Animal Models
- Cancer Biology
- Immunofluorescence
- Gene Therapy
- Genotyping
- Cloning
- Water Testing
- Medical Affairs
- Lab Safety
- Assay Development
- ICH Guidelines
- Pharmacovigilance
- Clinical Laboratory Operations
- Experimental Design
- Quality Systems
- Institutional Review Board
- ISO 13485
- Medical Writing
- Drug Development
- GxP
- Change Control
- Microscopy
- Molecular Biology
- Biotechnology
- Quality Management Systems
- Polymerase Chain Reaction
- Laboratory Management
- Microbiology
- Biology
- Medical Device Sales
- Clinical Trials
- Good Manufacturing Practices
- Clinical Research
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Strategy Development
- Engineering
- Quality Control
- Collections
- Implementation
- Auditing
- Collaboration
- Documentation
- Reporting
- Mentoring
- Investigation
- Inventory Management
- Interpersonal Skills
- Education Experience
- Quality Assurance
- Policy Development
- Problem Solving
- Bachelor's Degree
- Project Management
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- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
- Fermentation
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