Director of Quality Assurance and Regulatory Affairs Jobs in Alameda, 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.
Regulatory Affairs Manager APAC - Diabetes Care (on-site)
- Alameda, CA
- 45+ days ago
- Alameda, CA
- 45+ 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 (11 miles from Alameda, CA)
- 3 days ago
- South San Francisco, CA (11 miles from Alameda, CA)
- 3 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...
- San Francisco, CA (7 miles from Alameda, CA)
- 3 days ago
- San Francisco, CA (7 miles from Alameda, CA)
- 3 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...
Senior Director, Regulatory Affairs
- San Francisco, CA (7 miles from Alameda, CA)
- 3 days ago
- San Francisco, CA (7 miles from Alameda, CA)
- 3 days ago
About the Company Marea Therapeutics is a clinical-stage biotechnology company based in San Francisco with a growing pipeline of first-in-class therapies to address genetically validated...
Senior Manager, Regulatory Affairs
- Menlo Park, CA (22 miles from Alameda, CA)
- 6 days ago
- Menlo Park, CA (22 miles from Alameda, CA)
- 6 days ago
Overview of Role: Reporting to Head of Regulatory Affairs, the Senior Manager of Regulatory Affairs will support the day-to-day regulatory activities of assigned projects. These assigned projects...
Jones Lab - Junior/Assistant/Associate/Full Specialist (Lab Manager)
- San Francisco, CA (7 miles from Alameda, CA)
- 7 days ago
- San Francisco, CA (7 miles from Alameda, CA)
- 7 days ago
culture or animal models Skills in tissue dissections and molecular biology techniques, including working with DNA, protein (immunoprecipitation and Western blotting), RNA extraction, qPCR and qRT-PCR...
Associate Director, Regulatory Affairs
- Redwood City, CA (21 miles from Alameda, CA)
- 7 days ago
- Redwood City, CA (21 miles from Alameda, CA)
- 7 days ago
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline...
Director, Quality Assurance for Quality Control, Drug Product
- San Carlos, CA (19 miles from Alameda, CA)
- 9 days ago
- San Carlos, CA (19 miles from Alameda, CA)
- 9 days ago
Experience working with biochemistry, immunoassay, or microbiological assay techniques in a Quality Control environment....
- San Francisco, CA (7 miles from Alameda, CA)
- 9 days ago
- San Francisco, CA (7 miles from Alameda, CA)
- 9 days ago
culture or animal models Skills in tissue dissections and molecular biology techniques, including working with DNA, protein (immunoprecipitation and Western blotting), RNA extraction, qPCR and qRT-PCR...
Manager/Sr. Manager, Quality Assurance Operations
- San Francisco, CA (7 miles from Alameda, CA)
- 10 days ago
- San Francisco, CA (7 miles from Alameda, CA)
- 10 days ago
About Eidos Therapeutics & BridgeBio Pharma Eidos Therapeutics, an affiliate of BridgeBio Pharma, is a commercial stage biopharmaceutical company focused on addressing the large and growing unmet...
Director Regulatory Affairs Labeling
- San Francisco, CA (7 miles from Alameda, CA)
- 11 days ago
- San Francisco, CA (7 miles from Alameda, CA)
- 11 days ago
Company Overview Pliant Therapeutics is a late-stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. Founded by Third Rock Ventures...
- Emeryville, CA (4 miles from Alameda, CA)
- 14 days ago
- Emeryville, CA (4 miles from Alameda, CA)
- 14 days ago
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic...
Associate Director, Regulatory Affairs CMC
- San Francisco, CA (7 miles from Alameda, CA)
- 15 days ago
- San Francisco, CA (7 miles from Alameda, CA)
- 15 days ago
Pliant is seeking a dedicated and creative regulatory CMC professional to contribute to the Company's mission of helping patients with life-threatening fibrotic diseases. The position will report...
- South San Francisco, CA (11 miles from Alameda, CA)
- 17 days ago
- South San Francisco, CA (11 miles from Alameda, CA)
- 17 days ago
Clinical Practice), Regulatory Affairs Operations, Regulatory Affairs Strategy, Regulatory Briefing Documents, Submissions Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation...
Remote Work- Berkeley, CA (6 miles from Alameda, CA)
- 19 days ago
- Berkeley, CA (6 miles from Alameda, CA)
- 19 days ago
Experience with concepts of mammalian cell biology and subcellular organelles....
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Highest Education Level
Director of Quality Assurance and Regulatory Affairss in Alameda, 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
- English
- Quality Systems
- Supplier Management
- Distribution
- Implementation
- Resolution
- Safe Quality Food
- Coaching
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- Food Manufacturing
- 21 CFR 820
- Assay Development
- Real-Time Polymerase Chain Reaction
- Gene Therapy
- ICH Guidelines
- Genotyping
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Drug Discovery
- Pharmacovigilance
- Clinical Laboratory Operations
- DNA Isolation
- Drug Development
- Medical Writing
- Microbiology
- Biology
- Immunology
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Clinical Trials
- Biotechnology
- Laboratory Management
- FDA Regulations
- Medical Device Sales
- Good Manufacturing Practices
- Corrective Actions & Preventive Actions
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Military Background
- Troubleshooting
- Quality Control
- Investigation
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Inventory Management
- Regulations
- Teaching
- Policy Development
- Project Management
- Research Skills
- Microsoft Office
- Problem Solving
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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