Director of Quality Assurance and Regulatory Affairs Jobs in Menlo Park, 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 Vascular (on-site)
- Santa Clara, CA (14 miles from Menlo Park, CA)
- 1 day ago
- Santa Clara, CA (14 miles from Menlo Park, CA)
- 1 day 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
- Sunnyvale, CA (10 miles from Menlo Park, CA)
- 3 days ago
- Sunnyvale, CA (10 miles from Menlo Park, 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 (22 miles from Menlo Park, CA)
- 3 days ago
- Pleasanton, CA (22 miles from Menlo Park, 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 (14 miles from Menlo Park, CA)
- 4 days ago
- Santa Clara, CA (14 miles from Menlo Park, 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...
Manager/Senior Manager, Regulatory Affairs CMC
- South San Francisco, CA (18 miles from Menlo Park, CA)
- 5 days ago
- South San Francisco, CA (18 miles from Menlo Park, CA)
- 5 days ago
Requirements: Education: BA/BS degree in life science in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline....
Senior Director, Regulatory Affairs - Job ID: SDRA
- Palo Alto, CA (2 miles from Menlo Park, CA)
- 5 days ago
- Palo Alto, CA (2 miles from Menlo Park, 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 (2 miles from Menlo Park, CA)
- 6 days ago
- Palo Alto, CA (2 miles from Menlo Park, CA)
- 6 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...
- Alameda, CA (22 miles from Menlo Park, CA)
- 12 days ago
- Alameda, CA (22 miles from Menlo Park, 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 (18 miles from Menlo Park, CA)
- 16 days ago
- South San Francisco, CA (18 miles from Menlo Park, 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...
Senior Director, Regulatory Affairs Global Regulatory Leader
- Menlo Park, CA
- 27 days ago
- Menlo Park, 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...
Senior Regulatory Affairs Manager APAC - Diabetes Care (on-site)
- Alameda, CA (22 miles from Menlo Park, CA)
- 30+ days ago
- Alameda, CA (22 miles from Menlo Park, 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...
Associate Director, Quality Assurance and Compliance
- San Carlos, CA (5 miles from Menlo Park, CA)
- 45+ days ago
- San Carlos, CA (5 miles from Menlo Park, 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,...
Director, Regulatory Affairs-CMC
- South San Francisco, CA (18 miles from Menlo Park, CA)
- 45+ days ago
- South San Francisco, CA (18 miles from Menlo Park, 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...
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 (8 miles from Menlo Park, CA)
- 60+ days ago
- Foster City, CA (8 miles from Menlo Park, 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...
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Director of Quality Assurance and Regulatory Affairss in Menlo Park, 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
- Problem Solving
- Research Skills
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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