Director of Quality Assurance and Regulatory Affairs Jobs in Stanford, 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 (10 miles from Stanford, CA)
- 4 days ago
- Foster City, CA (10 miles from Stanford, 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 (19 miles from Stanford, CA)
- 6 days ago
- Milpitas, CA (19 miles from Stanford, 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...
Senior Regulatory Affairs Manager APAC - Diabetes Care (on-site)
- Alameda, CA (24 miles from Stanford, CA)
- 7 days ago
- Alameda, CA (24 miles from Stanford, 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 Carlos, CA (7 miles from Stanford, CA)
- 14 days ago
- San Carlos, CA (7 miles from Stanford, 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 (1 mile from Stanford, CA)
- 16 days ago
- Palo Alto, CA (1 mile from Stanford, 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...
- South San Francisco, CA (21 miles from Stanford, CA)
- 18 days ago
- South San Francisco, CA (21 miles from Stanford, CA)
- 18 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 (22 miles from Stanford, CA)
- 18 days ago
- Brisbane, CA (22 miles from Stanford, 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...
- Palo Alto, CA (1 mile from Stanford, CA)
- 19 days ago
- Palo Alto, CA (1 mile from Stanford, 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 (1 mile from Stanford, CA)
- 22 days ago
- Palo Alto, CA (1 mile from Stanford, 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...
Associate Manager/Manager, Quality Assurance
- Burlingame, CA (14 miles from Stanford, CA)
- 22 days ago
- Burlingame, CA (14 miles from Stanford, CA)
- 22 days ago
Compliance: Ensure compliance with current Good Manufacturing Practices (cGMPs), Good Clinical Practices (GCPs), Good Laboratory Practices (GLPs), FDA regulations, ICH guidelines, 21 CFR Part 11, and...
- South San Francisco, CA (21 miles from Stanford, CA)
- 26 days ago
- South San Francisco, CA (21 miles from Stanford, CA)
- 26 days ago
Supports the conduct of clinical trials and approval of marketing applications while holding responsibility for the maintenance of these applications (INDs, CTAs, DMFs, BLAs, MAAs)....
Regulatory Affairs Manager Canada & Latin America Diabetes Care (on-site)
- Alameda, CA (24 miles from Stanford, CA)
- 27 days ago
- Alameda, CA (24 miles from Stanford, CA)
- 27 days ago
Preferred Qualifications Bachelors degree in Biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology math, engineering, or medical fields....
- Santa Clara, CA (12 miles from Stanford, CA)
- 30+ days ago
- Santa Clara, CA (12 miles from Stanford, CA)
- 30+ days ago
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 (10 miles from Stanford, CA)
- 30+ days ago
- Foster City, CA (10 miles from Stanford, 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...
Commercial Regulatory Affairs Director
- Alameda, CA (24 miles from Stanford, CA)
- 30+ days ago
- Alameda, CA (24 miles from Stanford, CA)
- 30+ days ago
Reviews and approves clinical development communications and materials in support of Exelixis clinical trials, including site training slides and newsletters....
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Director of Quality Assurance and Regulatory Affairss in Stanford, 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
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- Hazardous Materials
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- Document Control
- Coaching
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- ISO 13485
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- Control Systems
- Batch Record Review
- GxP
- TrackWise
- Institutional Review Board
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
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- Molecular Biology
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- Drug Development
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- Laboratory Management
- Medical Device Sales
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- 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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