Manager of Quality Assurance and Regulatory Affairs Jobs in Stanford, CA
A Manager of Quality Assurance and Regulatory Affairs in the biotechnology industry is responsible for ensuring that all products and services meet required standards and regulations. They ensure compliance with local, national, and international regulatory requirements, oversee quality control processes, and manage audits and inspections. This role also involves creating and implementing policies and procedures to enhance product quality, efficiency, and safety. They also play a crucial role in the product development process, advising on regulatory requirements and ensuring that compliance is maintained throughout the lifecycle of a product.
Skills required for this role include excellent attention to detail, strong organizational and leadership skills, and in-depth knowledge of regulatory standards and quality control methods. In addition, they should have excellent problem-solving skills, the ability to work under pressure, and strong communication skills. They should also have a strong understanding of biotechnology principles and processes. Certifications such as Certified Quality Auditor (CQA), Certified Quality Manager (CQM), or Regulatory Affairs Certification (RAC) are often required. Prior roles that can lead to a Manager of Quality Assurance and Regulatory Affairs include Quality Assurance Specialist, Regulatory Affairs Associate, and Quality Control Supervisor.
Regulatory Affairs Manager APAC - Diabetes Care (on-site)
- Alameda, CA (24 miles from Stanford, CA)
- 45+ days ago
- Alameda, CA (24 miles from Stanford, CA)
- 45+ days ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...
Director, Regulatory Affairs-CMC
- South San Francisco, CA (21 miles from Stanford, CA)
- 3 days ago
- South San Francisco, CA (21 miles from Stanford, CA)
- 3 days ago
The Position: Maze Therapeutics is seeking a Director, Regulatory Affairs-CMC to be a key driver of CMC regulatory strategy for our clinical-stage small molecule programs. In this highly...
- Milpitas, CA (19 miles from Stanford, CA)
- 4 days ago
- Milpitas, CA (19 miles from Stanford, CA)
- 4 days ago
Job description Leanteq is best-in-class in a very niche part of the semiconductor industry and is looking for quality-oriented people who enjoy working in a great culture to join our team. Our...
Sr Manager, Regulatory Affairs (Remote) - Shockwave
- Santa Clara, CA (12 miles from Stanford, CA)
- 6 days ago
- Santa Clara, CA (12 miles from Stanford, CA)
- 6 days ago
J&J Family of Companies Sr Manager, Regulatory Affairs (Remote) - Shockwave in Santa Clara , California At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation...
Remote WorkSenior Manager, Regulatory Affairs
- Menlo Park, CA (2 miles from Stanford, CA)
- 6 days ago
- Menlo Park, CA (2 miles from Stanford, CA)
- 6 days ago
Overview of Role: Reporting to Head of Regulatory Affairs, the Senior Manager of Regulatory Affairs will support the day-to-day regulatory activities of assigned projects. These assigned projects...
Associate Director, Regulatory Affairs
- Redwood City, CA (4 miles from Stanford, CA)
- 7 days ago
- Redwood City, CA (4 miles from Stanford, CA)
- 7 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...
Director, Quality Assurance for Quality Control, Drug Product
- San Carlos, CA (7 miles from Stanford, CA)
- 9 days ago
- San Carlos, CA (7 miles from Stanford, CA)
- 9 days ago
Experience working with biochemistry, immunoassay, or microbiological assay techniques in a Quality Control environment....
- South San Francisco, CA (21 miles from Stanford, CA)
- 16 days ago
- South San Francisco, CA (21 miles from Stanford, CA)
- 16 days ago
Clinical Practice), Regulatory Affairs Operations, Regulatory Affairs Strategy, Regulatory Briefing Documents, Submissions Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation...
Remote WorkAssociate Director, Regulatory Affairs Advertising and Promotion
- Foster City, CA (10 miles from Stanford, CA)
- 20 days ago
- Foster City, CA (10 miles from Stanford, CA)
- 20 days ago
For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Gilead, we're creating a healthier world for all people. For more than 35 years,...
- Foster City, CA (10 miles from Stanford, CA)
- 20 days ago
- Foster City, CA (10 miles from Stanford, CA)
- 20 days ago
MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important...
Associate Director, Regulatory Affairs
- Foster City, CA (10 miles from Stanford, CA)
- 20 days ago
- Foster City, CA (10 miles from Stanford, CA)
- 20 days ago
MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important...
- South San Francisco, CA (21 miles from Stanford, CA)
- 21 days ago
- South San Francisco, CA (21 miles from Stanford, CA)
- 21 days ago
Job Title: Lab Manager Location: South San Francisco, CA FLSA Status: Exempt Full/Part-Time: Regular Full-time Reports to: Associate Director, Lab Operations About SonoThera SonoThera is a venture...
Regulatory Affairs Director - Oncology Cell & Gene Therapy
- South San Francisco, CA (21 miles from Stanford, CA)
- 21 days ago
- South San Francisco, CA (21 miles from Stanford, CA)
- 21 days ago
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the worlds...
Associate Director, Quality Assurance, Validation
- San Carlos, CA (7 miles from Stanford, CA)
- 24 days ago
- San Carlos, CA (7 miles from Stanford, CA)
- 24 days ago
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases,...
Executive Director, Regulatory Affairs CMC
- Alameda, CA (24 miles from Stanford, CA)
- 27 days ago
- Alameda, CA (24 miles from Stanford, CA)
- 27 days ago
SUMMARY/JOB PURPOSE: This role provides CMC Regulatory expertise and leadership for commercial and development projects. This role leads all regulatory activities related to chemistry,...
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Manager 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 Manager of Quality Assurance and Regulatory Affairs position
- English
- Quality Systems
- Supplier Management
- Distribution
- Implementation
- Resolution
- Safe Quality Food
- Coaching
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- Food Manufacturing
- 21 CFR 820
- Assay Development
- Real-Time Polymerase Chain Reaction
- Gene Therapy
- ICH Guidelines
- Genotyping
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Drug Discovery
- Pharmacovigilance
- Clinical Laboratory Operations
- DNA Isolation
- Drug Development
- Medical Writing
- Microbiology
- Biology
- Immunology
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Clinical Trials
- Biotechnology
- Laboratory Management
- FDA Regulations
- Medical Device Sales
- Good Manufacturing Practices
- Corrective Actions & Preventive Actions
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Military Background
- Troubleshooting
- Quality Control
- Investigation
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Inventory Management
- Regulations
- Teaching
- Policy Development
- Project Management
- Research Skills
- Microsoft Office
- Problem Solving
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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