Manager of Quality Assurance and Regulatory Affairs Jobs in Santa Clara, 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.
Environmental Science Lab Manager Stanford University
- Stanford, CA (12 miles from Santa Clara, CA)
- 16 hours ago
- Stanford, CA (12 miles from Santa Clara, CA)
- 16 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....
Environmental Science Lab Manager
- Stanford, CA (12 miles from Santa Clara, CA)
- 2 days ago
- Stanford, CA (12 miles from Santa Clara, 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...
Manager, Regulatory Affairs- Body Contouring
- Pleasanton, CA (21 miles from Santa Clara, CA)
- 3 days ago
- Pleasanton, CA (21 miles from Santa Clara, CA)
- 3 days ago
are clearly defined and documented.a Proactively resolve issues related to outsourced activities.a Updates and maintains appropriate SOPs for the departments.QualificationsBS or BA in engineering, biology...
Lab Manager (Industrial Robotics and Automation)
- Mountain View, CA (7 miles from Santa Clara, CA)
- 4 days ago
- Mountain View, CA (7 miles from Santa Clara, CA)
- 4 days ago
Intrinsic is Alphabet's bet aiming to reimagine the potential of industrial robotics. Our team believes that advances in AI, perception and simulation will redefine what's possible for industrial...
Director, Regulatory Affairs CMC
- Foster City, CA (22 miles from Santa Clara, CA)
- 17 days ago
- Foster City, CA (22 miles from Santa Clara, 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...
- Palo Alto, CA (12 miles from Santa Clara, CA)
- 29 days ago
- Palo Alto, CA (12 miles from Santa Clara, 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...
- Palo Alto, CA (12 miles from Santa Clara, CA)
- 30+ days ago
- Palo Alto, CA (12 miles from Santa Clara, CA)
- 30+ 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 (12 miles from Santa Clara, CA)
- 30+ days ago
- Palo Alto, CA (12 miles from Santa Clara, 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...
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 (22 miles from Santa Clara, CA)
- 45+ days ago
- Foster City, CA (22 miles from Santa Clara, CA)
- 45+ 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...
Research Coordinator & Lab Manager @ 50% FTE (Remote Opportunity)
- Stanford, CA (12 miles from Santa Clara, CA)
- 60+ days ago
- Stanford, CA (12 miles from Santa Clara, CA)
- 60+ days ago
Stanford University is seeking a Research Coordinator & Lab Manager working remotely and required to go on-site 1 day or less per week. This position will perform duties related to data quality...
Regulatory Affairs Manager Vascular (on-site)
- Santa Clara, CA
- 60+ days ago
- Santa Clara, CA
- 60+ days ago
Preferred Qualifications Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields....
Associate Director, Regulatory Affairs
- Foster City, CA (22 miles from Santa Clara, CA)
- 90+ days ago
- Foster City, CA (22 miles from Santa Clara, CA)
- 90+ days ago
Support the Clinical Operation Team with Clinical Trial Applications. Leads the preparation and the critical review of submission documents to ensure compliance with regulatory requirements....
- Stanford, CA (12 miles from Santa Clara, CA)
- 90+ days ago
- Stanford, CA (12 miles from Santa Clara, CA)
- 90+ 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...
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Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in Santa Clara, 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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