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.
Research Coordinator & Lab Manager @ 50% FTE (Remote Opportunity)
- Stanford, CA
- 11 hours ago
- Stanford, CA
- 11 hours 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...
(Associate) Director/Senior Director, Regulatory Affairs, Therapeutics
- Brisbane, CA
- 1 day ago
- Brisbane, CA
- 1 day ago
Associate) Director/Senior Director, Regulatory Affairs, Therapeutics in Brisbane Job Ref: ... Employer: Network Company Name: Mammoth Biosciences Industry: Executive Job Type: Full Time State:...
Requirements: Education: BA/BS degree in life science in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline....
biology, and protein sciences.Extremely reliable, organized, and hard-working and is a quick learner who understands the dynamics of a scientific lab.When needed, works beyond the 9-5 norm to ensure...
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Brisbane, CA
- 5 days ago
- Brisbane, CA
- 5 days ago
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely...
Lab Manager (Industrial Robotics and Automation)
- Mountain View, CA
- 5 days ago
- Mountain View, CA
- 5 days ago
Knowledge of lab safety regulations and procedures (ISO 10218, ANSI/RIA R15.06, etc) The US base salary range for this full-time position is between $128,000 - $136,000 + bonus + equity + benefits....
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 and executional...
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...
Career Category Quality Job Description Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients...
Regulatory Affairs Manager - Heart Failure (on-site)
- Pleasanton, CA
- 10 days ago
- Pleasanton, CA
- 10 days ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...
Senior Director / Executive Director of Regulatory Affairs
- Santa Clara, CA
- 11 days ago
- Santa Clara, CA
- 11 days ago
Senior Director / Executive Director of Regulatory Affairs W2 Contract-to-Hire Salary Range: $343,200 - $364,000 per year Location: Redwood City, CA - Hybrid or Remote PST Duties and...
Senior Director, Regulatory Affairs - Job ID: SDRA
- Palo Alto, CA
- 12 days ago
- Palo Alto, CA
- 12 days ago
Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease...
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Responsibilities: Join Thermo Fisher Scientific Inc. as a Manager, Regulatory Affairs, and play a pivotal role in...
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe...
Director/Sr. Director, Regulatory Affairs (Strategy, Immunology And Inflammation)
- San Francisco, CA
- 14 days ago
- San Francisco, CA
- 14 days ago
At Nurix, we believe in the science of possibility.We are committed to advancing groundbreaking science and innovation in targeted protein degradation to transform patients' lives.If you're...
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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
- Verbal Communication
- Mentoring
- Quality Systems
- Change Control
- Coaching
- Quality Management Systems
- Batch Record Review
- GxP
- Institutional Review Board
- Assay Development
- Biomarkers
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Genotyping
- Cell Culture
- Molecular Biology
- Cloning
- Polymerase Chain Reaction
- Cancer Biology
- DNA Isolation
- Drug Development
- Biology
- Pharmacovigilance
- Stem Cells
- Microbiology
- Clinical Trials
- Good Laboratory Practice
- Biotechnology
- Clinical Research
- Laboratory Management
- Neurology
- Oncology
- FDA Regulations
- Research and Development
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Medical Terminology
- Engineering
- Strategy Development
- Quality Control
- Military Background
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Regulations
- Policy Development
- Problem Solving
- Research Skills
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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