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.
Regulatory Affairs Manager Canada & Latin America Diabetes Care (on-site)
- Alameda, CA
- 30+ days ago
- Alameda, CA
- 30+ days ago
Preferred Qualifications Bachelors degree in Biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology math, engineering, or medical fields....
Environmental Science Lab Manager Stanford University
- Stanford, CA (24 miles from Alameda, CA)
- 15 hours ago
- Stanford, CA (24 miles from Alameda, CA)
- 15 hours ago
This position has been deemed critical by the Stanford Doerr School of Sustainability Dean's Office and is exempt from the hiring pause. This position is based on Stanford's main campus....
Clinical Research Regulatory Affairs Manager
- South San Francisco, CA (11 miles from Alameda, CA)
- 1 day ago
- South San Francisco, CA (11 miles from Alameda, CA)
- 1 day ago
Who You Are: Required Education: Bachelors degree in pharmacy, biology, chemistry, pharmacology, or related life sciences Required Experience: 5+ years of regulatory experience in IVD, companion diagnostics...
Environmental Science Lab Manager
- Stanford, CA (24 miles from Alameda, CA)
- 2 days ago
- Stanford, CA (24 miles from Alameda, CA)
- 2 days ago
This position has been deemed critical by the Stanford Doerr School of Sustainability Deans Office and is exempt from the hiring pause. This position is based on Stanfords main campus. Interested...
Director, Regulatory Affairs Medical Writer
- South San Francisco, CA (11 miles from Alameda, CA)
- 2 days ago
- South San Francisco, CA (11 miles from Alameda, CA)
- 2 days ago
Sutro Biopharma, Inc. is looking for a Director, Regulatory Affairs Medical Writer who will provide leadership in development and execution of document deliverables intended to support clinical trial...
Director, Regulatory Affairs CMC
- Foster City, CA (15 miles from Alameda, CA)
- 17 days ago
- Foster City, CA (15 miles from Alameda, CA)
- 17 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...
Senior Regulatory Affairs Manager APAC - Diabetes Care (on-site)
- Alameda, CA
- 19 days ago
- Alameda, CA
- 19 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 Francisco, CA (7 miles from Alameda, CA)
- 23 days ago
- San Francisco, CA (7 miles from Alameda, CA)
- 23 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....
- Palo Alto, CA (23 miles from Alameda, CA)
- 29 days ago
- Palo Alto, CA (23 miles from Alameda, CA)
- 29 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...
Senior Director, Regulatory Affairs (CMC)
- Brisbane, CA (9 miles from Alameda, CA)
- 30+ days ago
- Brisbane, CA (9 miles from Alameda, CA)
- 30+ 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...
Director, Regulatory Affairs - Job ID: DRA
- Palo Alto, CA (23 miles from Alameda, CA)
- 30+ days ago
- Palo Alto, CA (23 miles from Alameda, CA)
- 30+ 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...
Senior Regulatory Affairs Manager
- Pacheco, CA (15 miles from Alameda, CA)
- 30+ days ago
- Pacheco, CA (15 miles from Alameda, CA)
- 30+ days ago
Senior Regulatory Affairs Manager Pacheco, California, United States Our Company Biocare Medical, LLC is an innovator in developing and supplying world class automated immunohistochemistry...
- South San Francisco, CA (11 miles from Alameda, CA)
- 30+ days ago
- South San Francisco, CA (11 miles from Alameda, CA)
- 30+ 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)....
Core Lab Manager University of California San Francisco
- San Francisco, CA (7 miles from Alameda, CA)
- 45+ days ago
- San Francisco, CA (7 miles from Alameda, CA)
- 45+ days ago
The Core Lab Manager provides daily operational management support for the Clinical Laboratory in assigned areas. Manages productivity, technical performance of specimen processing and laboratory...
- San Francisco, CA (7 miles from Alameda, CA)
- 45+ days ago
- San Francisco, CA (7 miles from Alameda, CA)
- 45+ days ago
The Core Lab Manager provides daily operational management support for the Clinical Laboratory in assigned areas. Manages productivity, technical performance of specimen processing and laboratory...
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Highest Education Level
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
- Continuous Improvement
- Affirmative Action
- Quality Systems
- Implementation
- Quality Management
- Coaching
- Inspections
- Quality Management Systems
- Batch Record Review
- Internal Audits
- GxP
- TrackWise
- Institutional Review Board
- ICH GCP
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Neurobiology
- Clinical Laboratory Operations
- Biology
- Biochemistry
- Drug Development
- Immunology
- Microbiology
- Immunohistochemistry
- Experimental Design
- Biotechnology
- Scientific Writing
- Clinical Trials
- Laboratory Management
- Equipment Calibration
- Medical Device Sales
- Corrective Actions & Preventive Actions
- FDA Regulations
- Research and Development
- Good Manufacturing Practices
- Standard Operating Procedures
- Masters In Education
- Engineering
- Strategy Development
- Quality Control
- Auditing
- Investigation
- Written Communication
- Education Experience
- Quality Assurance
- Collaboration
- Documentation
- Reporting
- Bachelor's Degree
- Inventory Management
- Regulations
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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