Director of Quality Assurance and Regulatory Affairs Jobs in Santa Clara, 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.
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
- Sunnyvale, CA (4 miles from Santa Clara, CA)
- 3 days ago
- Sunnyvale, CA (4 miles from Santa Clara, 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...
Regulatory Affairs Manager - Heart Failure (on-site)
- Pleasanton, CA (21 miles from Santa Clara, CA)
- 3 days ago
- Pleasanton, CA (21 miles from Santa Clara, CA)
- 3 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
- 4 days ago
- Santa Clara, CA
- 4 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 miles from Santa Clara, CA)
- 5 days ago
- Palo Alto, CA (12 miles from Santa Clara, CA)
- 5 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...
- Palo Alto, CA (12 miles from Santa Clara, CA)
- 7 days ago
- Palo Alto, CA (12 miles from Santa Clara, CA)
- 7 days ago
Position OverviewWe are seeking an experienced Director of Regulatory Affairs to develop and execute global regulatory strategies across clinical, non-clinical, and CMC areas.This role will be...
Senior Director, Regulatory Affairs Global Regulatory Leader
- Menlo Park, CA (14 miles from Santa Clara, CA)
- 27 days ago
- Menlo Park, CA (14 miles from Santa Clara, CA)
- 27 days ago
Overview of Role: The Senior Director of Regulatory Affairs - Global Regulatory Leader, is responsible for developing and implementing global strategies to secure IND/CTA approvals for various...
Associate Director, Quality Assurance and Compliance
- San Carlos, CA (20 miles from Santa Clara, CA)
- 45+ days ago
- San Carlos, CA (20 miles from Santa Clara, CA)
- 45+ days ago
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases,...
Senior Manager, Regulatory Affairs
- Menlo Park, CA (14 miles from Santa Clara, CA)
- 45+ days ago
- Menlo Park, CA (14 miles from Santa Clara, CA)
- 45+ 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...
Associate Director, Regulatory Affairs Advertising and Promotion
- Foster City, CA (22 miles from Santa Clara, CA)
- 60+ days ago
- Foster City, CA (22 miles from Santa Clara, 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...
Associate Director, Regulatory Affairs
- Foster City, CA (22 miles from Santa Clara, CA)
- 60+ days ago
- Foster City, CA (22 miles from Santa Clara, CA)
- 60+ days ago
MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important...
- Stanford, CA (12 miles from Santa Clara, CA)
- 60+ days ago
- Stanford, CA (12 miles from Santa Clara, CA)
- 60+ days ago
At least one year of research experience in molecular biology and cell culture, and proficiency in animal necropsy, tissue dissociation, flow cytometry, immunocytochemistry, tissue cryo-sectioning and...
Associate Director, Regulatory Affairs CMC
- Foster City, CA (22 miles from Santa Clara, CA)
- 60+ days ago
- Foster City, CA (22 miles from Santa Clara, CA)
- 60+ days ago
For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Gilead, were creating a healthier world for all people. For more than 35 years,...
Manager, Regulatory Affairs- Body Contouring
- Pleasanton, CA (21 miles from Santa Clara, CA)
- 90+ days ago
- Pleasanton, CA (21 miles from Santa Clara, CA)
- 90+ days ago
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive...
Director / Senior Director, Regulatory Affairs
- Redwood City, CA (17 miles from Santa Clara, CA)
- 90+ days ago
- Redwood City, CA (17 miles from Santa Clara, CA)
- 90+ days ago
About Soleno Therapeutics Inc Soleno Therapeutics, Inc., based in Redwood City, California, is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare...
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Director of Quality Assurance and Regulatory Affairss in Santa Clara, 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
- Polymerase Chain Reaction
- DNA Isolation
- Drug Development
- Western Blot
- 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
- Problem Solving
- Research Skills
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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