Director of Quality Assurance and Regulatory Affairs Jobs in Mountain View, 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.
- Newark, CA (7 miles from Mountain View, CA)
- 2 days ago
- Newark, CA (7 miles from Mountain View, CA)
- 2 days ago
Preferred Qualifications: Bachelor's degree in Chemistry, Biology, Pharmaceutical Science or a related field....
Associate Director, Regulatory Affairs
- Redwood City, CA (10 miles from Mountain View, CA)
- 3 days ago
- Redwood City, CA (10 miles from Mountain View, CA)
- 3 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...
Senior Regulatory Affairs Manager - Oncology
- Palo Alto, CA (5 miles from Mountain View, CA)
- 5 days ago
- Palo Alto, CA (5 miles from Mountain View, CA)
- 5 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 (5 miles from Mountain View, CA)
- 5 days ago
- Palo Alto, CA (5 miles from Mountain View, CA)
- 5 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 (5 miles from Mountain View, CA)
- 6 days ago
- Palo Alto, CA (5 miles from Mountain View, CA)
- 6 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 (7 miles from Mountain View, CA)
- 11 days ago
- Menlo Park, CA (7 miles from Mountain View, CA)
- 11 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 (15 miles from Mountain View, CA)
- 11 days ago
- Foster City, CA (15 miles from Mountain View, CA)
- 11 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 (7 miles from Mountain View, CA)
- 12 days ago
- Santa Clara, CA (7 miles from Mountain View, CA)
- 12 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 (7 miles from Mountain View, CA)
- 12 days ago
- Santa Clara, CA (7 miles from Mountain View, CA)
- 12 days ago
Preferred Qualifications Bachelor's degree in science (biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology); math; engineering; or medical fields....
Associate Director/ Director, Regulatory Affairs
- Foster City, CA (15 miles from Mountain View, CA)
- 12 days ago
- Foster City, CA (15 miles from Mountain View, CA)
- 12 days ago
Associate Director/ Director, Regulatory Affairs About the Company: Dren Bio (the "Company") is a privately held, clinical stage biopharmaceutical company focused on developing therapeutic...
- Sunnyvale, CA (2 miles from Mountain View, CA)
- 12 days ago
- Sunnyvale, CA (2 miles from Mountain View, CA)
- 12 days ago
Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the...
- Fremont, CA (11 miles from Mountain View, CA)
- 17 days ago
- Fremont, CA (11 miles from Mountain View, CA)
- 17 days ago
software (e.g., LIMS, ELN) and standard office tools Adaptable and comfortable embracing new Lab Ops processes, technologies, and shifting responsibilities Preferred Qualifications Understanding of the molecular...
Regulatory Affairs Manager - Heart Failure
- Pleasanton, CA (19 miles from Mountain View, CA)
- 19 days ago
- Pleasanton, CA (19 miles from Mountain View, CA)
- 19 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 (10 miles from Mountain View, CA)
- 19 days ago
- Redwood City, CA (10 miles from Mountain View, CA)
- 19 days ago
In-depth knowledge and application of GMP and ICH Guidelines....
Regulatory Affairs Manager - Heart Failure (on-site)
- Pleasanton, CA (19 miles from Mountain View, CA)
- 28 days ago
- Pleasanton, CA (19 miles from Mountain View, CA)
- 28 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 Mountain View, CA
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Director of Quality Assurance and Regulatory Affairss in Mountain View, 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
- Quality Systems
- Implementation
- Change Control
- Inspections
- ISO 13485
- Quality Management Systems
- Batch Record Review
- GxP
- ICH GCP
- Assay Development
- Institutional Review Board
- Spectrophotometer
- Cancer Research
- Gene Therapy
- Lab Safety
- Molecular Biology
- ICH Guidelines
- Medical Affairs
- Next-Generation Sequencing
- Clinical Laboratory Operations
- Water Testing
- Biology
- Scientific Research
- Microbiology
- Drug Development
- Pharmacovigilance
- Fermentation
- Immunology
- Medical Writing
- Experimental Design
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Clinical Research
- Laboratory Management
- Medical Device Sales
- Good Manufacturing Practices
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Collections
- Strategy Development
- Quality Control
- Auditing
- Documentation
- Education Experience
- Investigation
- Collaboration
- Reporting
- Quality Assurance
- Inventory Management
- Interpersonal Skills
- Bachelor's Degree
- Policy Development
- Project Management
- Regulations
- Problem Solving
- Research Skills
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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