Manager of Quality Assurance and Regulatory Affairs Jobs in California
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....
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
- 12 hours ago
- South San Francisco, CA
- 12 hours 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...
Ref(LF33) Job Summary: Seeking a Laboratory Manager to oversee daily operations of a hospital laboratory, supervising Clinical Lab Scientists and Lab Assistants. Responsible for maintaining...
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: These may include but are not limited to: General Provide GCP quality assurance strategy and oversight of QA GCP operations Ensures that clinical trials and...
Remote Workare 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...
#ourjacobs #bia #omfs #challengeaccepted Bachelors degree in Chemistry, Biology, or related field from an accredited university or college Eight (8) years experience performing sophisticated analyses...
Requirements Bachelor's degree, preferably in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred....
Lab Manager (Industrial Robotics and Automation)
- Mountain View, CA
- 2 days ago
- Mountain View, CA
- 2 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...
The Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) sites that manufacture active pharmaceutical ingredients...
Quantitative Ecology Lab Manager (SRA 3)
- California City, CA
- 8 days ago
- California City, CA
- 8 days ago
science, biology, limnology, or a related discipline Experience using R, particularly with data management and visualization packages, familiarity with aquatic data collection in field and laboratory...
Principal Scientist (Director) - Regulatory Affairs-CMC
- Sacramento, CA
- 12 days ago
- Sacramento, CA
- 12 days ago
Fields of study include Biology, Microbiology,or Biochemistry, Chemical, Mechanical and Electrical Engineering. **** **Required Experience and Skills:** + Demonstrated experience in a CMC regulatory...
Education Bachelor's degree in a scientific discipline: Engineering, Biology, etc. or equivalent. Advanced degree (Master's degree or higher) preferred....
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...
development organizations Ensure Regulatory resources are available to support inspections conducted by global regulators Qualifications: M.S. degree in a technical discipline (e.g., engineering, biology...
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Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in California 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
- Document Control
- Coaching
- Inspections
- Quality Management Systems
- Batch Record Review
- GxP
- TrackWise
- Institutional Review Board
- ICH GCP
- Animal Models
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Neurobiology
- Molecular Biology
- Biology
- Biochemistry
- Drug Development
- Immunology
- Microbiology
- Immunohistochemistry
- Biotechnology
- Laboratory Management
- Equipment Calibration
- Medical Device Sales
- Corrective Actions & Preventive Actions
- FDA Regulations
- Research and Development
- Good Manufacturing Practices
- Process Development
- Standard Operating Procedures
- Engineering
- Strategy Development
- Quality Control
- Auditing
- Investigation
- Written Communication
- Education Experience
- Quality Assurance
- Collaboration
- Documentation
- Reporting
- Bachelor's Degree
- Inventory Management
- Regulations
- Project Management
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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