Manager of Quality Assurance and Regulatory Affairs Jobs in Pleasanton, 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.
- Milpitas, CA (15 miles from Pleasanton, CA)
- 4 days ago
- Milpitas, CA (15 miles from Pleasanton, 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 (21 miles from Pleasanton, CA)
- 6 days ago
- Santa Clara, CA (21 miles from Pleasanton, 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 (22 miles from Pleasanton, CA)
- 6 days ago
- Menlo Park, CA (22 miles from Pleasanton, 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 (24 miles from Pleasanton, CA)
- 7 days ago
- Redwood City, CA (24 miles from Pleasanton, 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...
Associate Director, Regulatory Affairs Advertising and Promotion
- Foster City, CA (23 miles from Pleasanton, CA)
- 20 days ago
- Foster City, CA (23 miles from Pleasanton, 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 (23 miles from Pleasanton, CA)
- 20 days ago
- Foster City, CA (23 miles from Pleasanton, 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 (23 miles from Pleasanton, CA)
- 20 days ago
- Foster City, CA (23 miles from Pleasanton, 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...
Lab Manager Stanford University
- Stanford, CA (23 miles from Pleasanton, CA)
- 29 days ago
- Stanford, CA (23 miles from Pleasanton, CA)
- 29 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...
- Palo Alto, CA (21 miles from Pleasanton, CA)
- 29 days ago
- Palo Alto, CA (21 miles from Pleasanton, CA)
- 29 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...
Associate Director, Regulatory Affairs CMC
- Foster City, CA (23 miles from Pleasanton, CA)
- 30+ days ago
- Foster City, CA (23 miles from Pleasanton, CA)
- 30+ days ago
For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Gilead, were creating a healthier world for all people. For more than 35 years,...
Manager, Regulatory Affairs- Body Contouring
- Pleasanton, CA
- 45+ days ago
- Pleasanton, CA
- 45+ days ago
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive...
Director / Senior Director, Regulatory Affairs Labeling, Advertising, and Promotion
- Redwood City, CA (24 miles from Pleasanton, CA)
- 60+ days ago
- Redwood City, CA (24 miles from Pleasanton, CA)
- 60+ 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...
Director / Senior Director, Regulatory Affairs
- Redwood City, CA (24 miles from Pleasanton, CA)
- 60+ days ago
- Redwood City, CA (24 miles from Pleasanton, CA)
- 60+ 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...
Director, Regulatory Affairs Data Governance Lead
- Foster City, CA (23 miles from Pleasanton, CA)
- 60+ days ago
- Foster City, CA (23 miles from Pleasanton, CA)
- 60+ days ago
For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Gilead, were creating a healthier world for all people. For more than 35 years,...
- Stanford, CA (23 miles from Pleasanton, CA)
- 60+ days ago
- Stanford, CA (23 miles from Pleasanton, CA)
- 60+ days ago
Lab Manager- On-Site The School of Humanities and Sciences (H&S) is the foundation of a liberal arts education at Stanford. The school encompasses 23 departments and 25 interdisciplinary programs....
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Manager of Quality Assurance and Regulatory Affairss in Pleasanton, 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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