Director of Quality Assurance and Regulatory Affairs Jobs in Berkeley, CA
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.
Associate Director, Regulatory Affairs
- San Francisco, CA (10 miles from Berkeley, CA)
- 2 hours ago
- San Francisco, CA (10 miles from Berkeley, CA)
- 2 hours ago
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...
Director Regulatory Affairs CMC
- San Francisco, CA (10 miles from Berkeley, CA)
- 3 days ago
- San Francisco, CA (10 miles from Berkeley, CA)
- 3 days ago
Director Regulatory Affairs CMC I am looking to speak with Director's of Regulatory Affairs CMC to lead the development and execution of global CMC regulatory strategies for clinical-stage small...
Manager/Senior Manager, Regulatory Affairs CMC
- South San Francisco, CA (16 miles from Berkeley, CA)
- 4 days ago
- South San Francisco, CA (16 miles from Berkeley, CA)
- 4 days ago
Requirements: Education: BA/BS degree in life science in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline....
Director/Sr. Director, Regulatory Affairs (Strategy, Immunology And Inflammation)
- San Francisco, CA (10 miles from Berkeley, CA)
- 6 days ago
- San Francisco, CA (10 miles from Berkeley, CA)
- 6 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...
- San Francisco, CA (10 miles from Berkeley, CA)
- 9 days ago
- San Francisco, CA (10 miles from Berkeley, CA)
- 9 days ago
The Position Join Maze Therapeutics as a Director, Regulatory Affairs, where you will play a critical leadership role in advancing our clinical-stage programs, providing regulatory expertise to...
- Alameda, CA (6 miles from Berkeley, CA)
- 12 days ago
- Alameda, CA (6 miles from Berkeley, CA)
- 12 days ago
The Opportunity The function of a Regulatory Affairs Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or...
Associate Director, Regulatory Affairs
- South San Francisco, CA (16 miles from Berkeley, CA)
- 16 days ago
- South San Francisco, CA (16 miles from Berkeley, CA)
- 16 days ago
The Position: 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...
About Us Ray Therapeutics is a clinical-stage biopharmaceutical company developing therapies to restore vision in patients affected with retinal degenerations. RayTx utilizes optogenetics to...
Associate Director, Regulatory Affairs
- San Francisco, CA (10 miles from Berkeley, CA)
- 30+ days ago
- San Francisco, CA (10 miles from Berkeley, CA)
- 30+ days ago
About QED Therapeutics & BridgeBio Pharma QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly...
Senior Regulatory Affairs Manager APAC - Diabetes Care (on-site)
- Alameda, CA (6 miles from Berkeley, CA)
- 30+ days ago
- Alameda, CA (6 miles from Berkeley, CA)
- 30+ 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...
Director, Regulatory Affairs-CMC
- South San Francisco, CA (16 miles from Berkeley, CA)
- 45+ days ago
- South San Francisco, CA (16 miles from Berkeley, CA)
- 45+ days ago
The Position: Maze Therapeutics is seeking a Director, Regulatory Affairs-CMC to be a key driver of CMC regulatory strategy for our clinical-stage small molecule programs. In this highly...
Senior Director Regulatory Affairs
- San Francisco, CA (10 miles from Berkeley, CA)
- 30+ days ago
- San Francisco, CA (10 miles from Berkeley, CA)
- 30+ days ago
Title: Senior Director Regulatory Affairs SUMMARY: A leading biopharmaceutical company is seeking a Sr. Director of Regulatory Affairs. This role involves developing and implementing global...
Lab Manager (9602C) 76850 University of California, Berkeley
- Berkeley, CA
- 45+ days ago
- Berkeley, CA
- 45+ days ago
Required Qualifications Experience with mouse handling, molecular biology and behavior techniques, and knowledge of lab safety procedures. Leadership skills and being able to work independently....
- San Francisco, CA (10 miles from Berkeley, CA)
- 45+ days ago
- San Francisco, CA (10 miles from Berkeley, CA)
- 45+ days ago
Required Qualifications Experience with mouse handling, molecular biology and behavior techniques, and knowledge of lab safety procedures. Leadership skills and being able to work independently....
Associate Director, Regulatory Affairs Advertising and Promotion
- Foster City, CA (21 miles from Berkeley, CA)
- 60+ days ago
- Foster City, CA (21 miles from Berkeley, CA)
- 60+ 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...
Demographic Data for Berkeley, CA
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Highest Education Level
Director of Quality Assurance and Regulatory Affairss in Berkeley, CA 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
- Verbal Communication
- Mentoring
- Quality Systems
- Implementation
- Change Control
- Coaching
- Quality Management Systems
- Batch Record Review
- GxP
- 21 CFR 820
- Assay Development
- Biomarkers
- Flow Cytometry
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Genotyping
- Next-Generation Sequencing
- Lab Safety
- Molecular Biology
- Cloning
- Clinical Laboratory Operations
- Polymerase Chain Reaction
- DNA Isolation
- Drug Development
- Biology
- Stem Cells
- Microbiology
- Biotechnology
- Clinical Trials
- Good Laboratory Practice
- Clinical Research
- Laboratory Management
- Neurology
- Oncology
- FDA Regulations
- Research and Development
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Control
- Military Background
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Interpersonal Skills
- Bachelor's Degree
- Reporting
- Education Experience
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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