Manager of Quality Assurance and Regulatory Affairs Jobs in Palo Alto, 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 (23 miles from Palo Alto, CA)
- 30+ days ago
- Alameda, CA (23 miles from Palo Alto, 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 (1 mile from Palo Alto, CA)
- 16 hours ago
- Stanford, CA (1 mile from Palo Alto, 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....
Clinical Research Regulatory Affairs Manager
- South San Francisco, CA (21 miles from Palo Alto, CA)
- 1 day ago
- South San Francisco, CA (21 miles from Palo Alto, 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 (1 mile from Palo Alto, CA)
- 2 days ago
- Stanford, CA (1 mile from Palo Alto, 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 (21 miles from Palo Alto, CA)
- 2 days ago
- South San Francisco, CA (21 miles from Palo Alto, 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...
Manager, Regulatory Affairs- Body Contouring
- Pleasanton, CA (21 miles from Palo Alto, CA)
- 3 days ago
- Pleasanton, CA (21 miles from Palo Alto, 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 (5 miles from Palo Alto, CA)
- 4 days ago
- Mountain View, CA (5 miles from Palo Alto, 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 (10 miles from Palo Alto, CA)
- 17 days ago
- Foster City, CA (10 miles from Palo Alto, 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 (23 miles from Palo Alto, CA)
- 19 days ago
- Alameda, CA (23 miles from Palo Alto, 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...
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 (22 miles from Palo Alto, CA)
- 30+ days ago
- Brisbane, CA (22 miles from Palo Alto, 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...
- Palo Alto, CA (2 miles from Palo Alto, CA)
- 30+ days ago
- Palo Alto, CA (2 miles from Palo Alto, 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 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...
- South San Francisco, CA (21 miles from Palo Alto, CA)
- 30+ days ago
- South San Francisco, CA (21 miles from Palo Alto, 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)....
- Santa Clara, CA (12 miles from Palo Alto, CA)
- 30+ days ago
- Santa Clara, CA (12 miles from Palo Alto, CA)
- 30+ days ago
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...
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Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in Palo Alto, 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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