Director of Quality Assurance and Regulatory Affairs Jobs in California
A Director of Quality Assurance and Regulatory Affairs in the biotechnology industry is essentially responsible for developing and implementing systems that ensure products meet quality standards and regulatory requirements. This includes conducting internal audits, leading investigations into quality issues, liaising with regulatory bodies, and overseeing the submission of regulatory documents. They are also responsible for ensuring compliance with regulatory requirements and standards such as ISO, FDA, and EMEA. They play a crucial role in maintaining the company's reputation and ensuring customer satisfaction by ensuring that products are safe, reliable, and meet both customer and regulatory requirements.
Key skills for this role include strong analytical and problem-solving skills, excellent communication skills, and a strong knowledge of the biotechnology industry and its associated regulations. They should also have strong leadership skills, as they will often be leading teams and coordinating with other departments. Important certifications may include Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Regulatory Affairs Certification (RAC), or Certified Quality Manager (CQM). Prior to becoming a Director of Quality Assurance and Regulatory Affairs, an individual may have roles such as Quality Assurance Manager, Regulatory Affairs Specialist, or Senior Quality Engineer within the industry.
Director/Senior Director, Regulatory Affairs (Clinical & CMC)
- San Francisco, CA
- 6 hours ago
- San Francisco, CA
- 6 hours ago
Director/Senior Director, Regulatory Affairs (Clinical & CMC) August 2025 Department: Regulatory Position Summary: The Director/Senior Director, Regulatory Affairs will lead and execute global...
Who we are The problem: Every minute matters in fire response. As climate change amplifies the intensity of wildfireswith longer fire seasons, dryer fuels, and faster windsnew ignitions spread...
Minimum qualifications: Bachelor's degree in Electrical Engineering, Computer Engineering, Computer Science, or a related field, or equivalent practical experience. 1 year of experience with...
Preferred Qualifications: Bachelor's degree in Chemistry, Biology, Pharmaceutical Science or a related field....
Associate Director, Quality Assurance
- South San Francisco, CA
- 3 days ago
- South San Francisco, CA
- 3 days ago
As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility...
: Bachelor's degree required; advanced degree in life sciences preferred. 7+ years or equivalent relevant experience in regulatory affairs in the biopharmaceutical industry Strong understanding of ICH...
Salary Statement Estimated Starting Salary Range: USD $84,000.00/Yr. - USD $139,950.00/Yr. Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant,...
Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees,...
Company Description Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is...
Company Description Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is...
Sentynl Therapeutics, a wholly owned subsidiary of the Zydus Lifesciences Ltd. (Zydus), is a commercial stage biopharmaceutical company focused on bringing innovative therapies to patients living...
Company Description Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is...
Director/Senior Director, Regulatory Affairs Strategy
- Menlo Park, CA
- 11 days ago
- Menlo Park, CA
- 11 days ago
and directly interfacing with US and international regulatory authorities Product development in therapeutic areas of dermatology, immunology or inflammation a plus Skills In depth knowledge of GXP/ICH...
Exec Director, Regulatory Affairs-Combination Products & Devices
- Foster City, CA
- 11 days ago
- Foster City, CA
- 11 days ago
In-depth understanding of ICH guidelines and GMP requirements for development and manufacturing of small molecules and biologics....
Senior Manager Regulatory Affairs - Global Regulatory Services
- Santa Clara, CA
- 12 days ago
- Santa Clara, CA
- 12 days ago
Preferred Qualifications Bachelor's degree in science (biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology); math; engineering; or medical fields....
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Highest Education Level
Director 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 Director of Quality Assurance and Regulatory Affairs position
- Mentoring
- Quality Systems
- Implementation
- Change Control
- Inspections
- Quality Management Systems
- Batch Record Review
- GxP
- ICH GCP
- Assay Development
- Institutional Review Board
- Animal Models
- Spectrophotometer
- Cancer Research
- Gene Therapy
- Lab Safety
- Molecular Biology
- ICH Guidelines
- Medical Affairs
- Next-Generation Sequencing
- Clinical Laboratory Operations
- Water Testing
- Biology
- Scientific Research
- Microbiology
- Drug Development
- Pharmacovigilance
- Fermentation
- Immunology
- Medical Writing
- Experimental Design
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Clinical Research
- Laboratory Management
- Medical Device Sales
- Good Manufacturing Practices
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Collections
- Strategy Development
- Quality Control
- Auditing
- Documentation
- Education Experience
- Investigation
- Collaboration
- Reporting
- Quality Assurance
- Inventory Management
- Interpersonal Skills
- Bachelor's Degree
- Policy Development
- Project Management
- Regulations
- Problem Solving
- Research Skills
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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