Manager of Quality Assurance and Regulatory Affairs Jobs in Alameda, 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.
Associate Director, Regulatory Affairs
- South San Francisco, CA (11 miles from Alameda, CA)
- 14 hours ago
- South San Francisco, CA (11 miles from Alameda, CA)
- 14 hours ago
The Position: Join Maze Therapeutics as an Associate Director, Regulatory Affairs, where you will play a critical role in advancing our clinical-stage programs by providing regulatory expertise...
Director of Regulatory Affairs
- Berkeley, CA (6 miles from Alameda, CA)
- 5 days ago
- Berkeley, CA (6 miles from Alameda, CA)
- 5 days ago
About Us Ray Therapeutics is a clinical-stage biopharmaceutical company developing therapies to restore vision in patients affected with retinal degenerations. RayTx utilizes optogenetics to...
Regulatory Affairs Director - Oncology Cell & Gene Therapy
- South San Francisco, CA (11 miles from Alameda, CA)
- 5 days ago
- South San Francisco, CA (11 miles from Alameda, CA)
- 5 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 world's...
Associate Director, Regulatory Affairs
- Redwood City, CA (21 miles from Alameda, CA)
- 6 days ago
- Redwood City, CA (21 miles from Alameda, CA)
- 6 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 Director, Regulatory Affairs Global Regulatory Leader
- Menlo Park, CA (22 miles from Alameda, CA)
- 12 days ago
- Menlo Park, CA (22 miles from Alameda, CA)
- 12 days ago
industry, and trade groups as appropriate Follows budget allocations All other duties as assigned Experience, Education and Specialized Knowledge and Skills: Bachelor's degree in life sciences (pharmacy, biology...
Executive Director, Regulatory Affairs
- Menlo Park, CA (22 miles from Alameda, CA)
- 12 days ago
- Menlo Park, CA (22 miles from Alameda, CA)
- 12 days ago
requirements Develops and follows budget allocations All other duties as assigned Experience, Education and Specialized Knowledge and Skills: Doctorate or Masters degree in life sciences (pharmacy, biology...
Manager/Sr Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology) - Remote
- San Francisco, CA (7 miles from Alameda, CA)
- 13 days ago
- San Francisco, CA (7 miles from Alameda, CA)
- 13 days ago
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in...
Remote WorkAssociate Director, Regulatory Affairs
- San Francisco, CA (7 miles from Alameda, CA)
- 17 days ago
- San Francisco, CA (7 miles from Alameda, CA)
- 17 days ago
About QED Therapeutics & BridgeBio Pharma QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly...
Associate Director, Quality Assurance and Compliance
- San Carlos, CA (19 miles from Alameda, CA)
- 30+ days ago
- San Carlos, CA (19 miles from Alameda, CA)
- 30+ days ago
., Biology, Chemistry, Engineering, or related field). 10+ years of experience in Quality Assurance, Compliance, or Regulatory Affairs in the biopharmaceutical or vaccine industry....
Director, Regulatory Affairs-CMC
- South San Francisco, CA (11 miles from Alameda, CA)
- 30+ days ago
- South San Francisco, CA (11 miles from Alameda, CA)
- 30+ 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...
Senior Regulatory Affairs Manager APAC - Diabetes Care (on-site)
- Alameda, CA
- 22 days ago
- Alameda, CA
- 22 days ago
Preferred Qualifications Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields; Masters degree...
Director, Regulatory Affairs CMC
- San Francisco, CA (7 miles from Alameda, CA)
- 27 days ago
- San Francisco, CA (7 miles from Alameda, CA)
- 27 days ago
About the Role >>> Director, Regulatory Affairs CMC As the Director, Regulatory Affairs CMC, reporting to the Senior Director, Regulatory Affairs CMC, you will be responsible for developing and...
Senior Director Regulatory Affairs
- San Francisco, CA (7 miles from Alameda, CA)
- 28 days ago
- San Francisco, CA (7 miles from Alameda, CA)
- 28 days ago
Title: Senior Director Regulatory Affairs SUMMARY: A leading biopharmaceutical company is seeking a Sr. Director of Regulatory Affairs. This role involves developing and implementing global...
Lab Manager (9602C) 76850 University of California, Berkeley
- Berkeley, CA (6 miles from Alameda, CA)
- 30+ days ago
- Berkeley, CA (6 miles from Alameda, CA)
- 30+ days ago
Required Qualifications Experience with mouse handling, molecular biology and behavior techniques, and knowledge of lab safety procedures. Leadership skills and being able to work independently....
- San Francisco, CA (7 miles from Alameda, CA)
- 30+ days ago
- San Francisco, CA (7 miles from Alameda, CA)
- 30+ days ago
Required Qualifications Experience with mouse handling, molecular biology and behavior techniques, and knowledge of lab safety procedures. Leadership skills and being able to work independently....
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Manager of Quality Assurance and Regulatory Affairss in Alameda, 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
- Mentoring
- Quality Systems
- Implementation
- Change Control
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- 21 CFR 820
- Institutional Review Board
- Assay Development
- Flow Cytometry
- Good Clinical Practice
- Real-Time Polymerase Chain Reaction
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Genotyping
- Lab Safety
- Molecular Biology
- Cloning
- Clinical Laboratory Operations
- Cancer Biology
- Polymerase Chain Reaction
- Western Blot
- DNA Isolation
- Drug Development
- Biology
- Medical Writing
- Pharmacovigilance
- Stem Cells
- Microbiology
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Scientific Writing
- Biotechnology
- Laboratory Management
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Collections
- Quality Control
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Reporting
- Education Experience
- Bachelor's Degree
- Inventory Management
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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