Manager of Quality Assurance and Regulatory Affairs Jobs in Pacheco, 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 (15 miles from Pacheco, CA)
- 30+ days ago
- Alameda, CA (15 miles from Pacheco, CA)
- 30+ days ago
Preferred Qualifications Bachelors degree in Biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology math, engineering, or medical fields....
Senior Regulatory Affairs Manager APAC - Diabetes Care (on-site)
- Alameda, CA (15 miles from Pacheco, CA)
- 19 days ago
- Alameda, CA (15 miles from Pacheco, 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 (19 miles from Pacheco, CA)
- 23 days ago
- San Francisco, CA (19 miles from Pacheco, 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....
Senior Director, Regulatory Affairs (CMC)
- Brisbane, CA (24 miles from Pacheco, CA)
- 30+ days ago
- Brisbane, CA (24 miles from Pacheco, 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...
Senior Regulatory Affairs Manager Pacheco, California, United States Our Company Biocare Medical, LLC is an innovator in developing and supplying world class automated immunohistochemistry...
Core Lab Manager University of California San Francisco
- San Francisco, CA (19 miles from Pacheco, CA)
- 45+ days ago
- San Francisco, CA (19 miles from Pacheco, 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 (19 miles from Pacheco, CA)
- 45+ days ago
- San Francisco, CA (19 miles from Pacheco, 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...
Commercial Regulatory Affairs Director
- Alameda, CA (15 miles from Pacheco, CA)
- 45+ days ago
- Alameda, CA (15 miles from Pacheco, CA)
- 45+ days ago
Reviews and approves clinical development communications and materials in support of Exelixis clinical trials, including site training slides and newsletters....
Regulatory Affairs Manager APAC - Diabetes Care (on-site)
- Alameda, CA (15 miles from Pacheco, CA)
- 90+ days ago
- Alameda, CA (15 miles from Pacheco, CA)
- 90+ days ago
Preferred Qualifications Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields....
Demographic Data for Pacheco, CA
Moving to Pacheco, CA? Find some basic demographic data about Pacheco, CA below.
Manager of Quality Assurance and Regulatory Affairs Online Courses and Training Opportunities
Title Synonyms
Users interested in this job title also searched for the following job titles
Salary for Manager of Quality Assurance and Regulatory Affairs Jobs in Pacheco, CA
Required or preferred licenses and certifications for Manager of Quality Assurance and Regulatory Affairs positions.
Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in Pacheco, 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
Other Career Titles
Here are some other career titles that require similar skills
Manager of Quality Assurance and Regulatory Affairs Related Career Advice Articles
4 Biotech Opportunities & Career Paths With High Growth Potential
Biotechnology is an emerging segment of the employment market with opportunities spanning healthcare, biopharmaceuticals, agriculture, industry, and academia. If you have a thirst for innovation, this career path might be right for you!
Read article »