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.

1-15 of 64 Jobs

Associate Director, Quality Assurance and Compliance

  • San Carlos, CA
  • 1 day ago
  • San Carlos, CA
  • 1 day 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,...

Lab Manager (9602C) 76850 University of California, Berkeley

  • Berkeley, CA
  • 1 day ago
  • Berkeley, CA
  • 1 day 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....

Lab Manager (9602C) 76850

  • San Francisco, CA
  • 1 day ago
  • San Francisco, CA
  • 1 day 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....

Lab Manager - CLS (ASCP) - Day Shift Location: Bodfish, CA Compensation: $141,000 - $200,000 annually (Based on experience) Schedule: Full-time, Day Shift About Us: Join our dedicated team in...

Senior Manager, Regulatory Affairs US Advertising and Promotion - Neuroscience

  • East Irvine, CA
  • 4 days ago
  • East Irvine, CA
  • 4 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 of Quality Assurance - Cell and Gene Therapy Operations

  • Duarte, CA
  • 4 days ago
  • Duarte, CA
  • 4 days ago

Join the forefront of groundbreaking research at the Beckman Research Institute of City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and...

Associate Director, Regulatory Affairs

  • San Diego, CA
  • 5 days ago
  • San Diego, CA
  • 5 days ago

Job Title: Associate Director, Regulatory Affairs Location: San Diego, CA / Hybrid / Remote Position type: FLSA: Full time Exempt Department: Finance ID: Regulatory 8300-Q224-9 Strive to Bring a...

Director, Regulatory Affairs-CMC

  • South San Francisco, CA
  • 5 days ago
  • South San Francisco, CA
  • 5 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...

Director, Regulatory Affairs

  • San Francisco, CA
  • 5 days ago
  • San Francisco, CA
  • 5 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
  • 5 days ago
  • San Francisco, CA
  • 5 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...

Analytical Lab Manager

  • Milpitas, CA
  • 6 days ago
  • Milpitas, CA
  • 6 days ago

Job description Leanteq is best-in-class in a very niche part of the semiconductor industry and is looking for quality-oriented people who enjoy working in a great culture to join our team. Our...

Senior Manager of Regulatory Affairs

  • Irvine, CA
  • 7 days ago
  • Irvine, CA
  • 7 days ago

Title: Regulatory Affairs Senior Manager Summary: Our client is seeking an experienced Senior Manager of Regulatory Affairs to lead the preparation and submission of global regulatory filings,...

Sr Manager, Regulatory Affairs (Remote) - Shockwave

  • Santa Clara, CA
  • 8 days ago
  • Santa Clara, CA
  • 8 days ago

J&J Family of Companies Sr Manager, Regulatory Affairs (Remote) - Shockwave in Santa Clara , California At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation...

Remote Work

Senior Manager, Regulatory Affairs

  • Menlo Park, CA
  • 8 days ago
  • Menlo Park, CA
  • 8 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...

Laboratory Manager in Central California Location Highlights: Low cost of living area Access to a wide range of outdoor water activities like boating, fishing, swimming, waterskiing and beautiful...

Demographic Data for California

Moving to California? Find some basic demographic data about California below.


Local
National
39,536,271
996,598

Director of Quality Assurance and Regulatory Affairs Online Courses and Training Opportunities

iHireBiotechnology curates thousands of courses in order to recommend the best ones to help further your career. If you register for a course using the links on our site, we may receive a small commission.
Certificate in Health Care Quality Assurance and Management
Course Title:Certificate in Healthcare Quality Assurance and ManagementCourse Overview: The Certificate in Health Care Quality Assurance and Management is designed to equip participants with the...
ISO 13485 Quality Assurance Course for Medical Devices
Welcome to the ISO 13485 Quality Assurance Course for Medical Devices-a complete, step-by-step guide designed to help you navigate and master ISO 13485, the internationally recognized standard for...
Regulatory Compliance for Biosimilars-Mastery Quiz
This comprehensive, 100+-question mastery quiz is designed for professionals in the biologics and biosimilars field who seek to deepen their understanding of regulatory compliance, quality...

Title Synonyms

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Salary for Director of Quality Assurance and Regulatory Affairs Jobs in California

Estimated salary range based on data from US Bureau of Labor Statistics (BLS) and iHireBiotechnology research efforts.

Highest Education Level

Director of Quality Assurance and Regulatory Affairss in California offer the following education background
Bachelor's Degree
35.9%
Master's Degree
31.7%
Doctorate Degree
25.6%
Associate's Degree
2.9%
Vocational Degree or Certification
1.7%
High School or GED
1.6%
Some College
0.5%
Some High School
0.1%

Average Work Experience
Here's a breakdown of the number of years' experience offered by Director of Quality Assurance and Regulatory Affairss in California
2-4 years
32.1%
4-6 years
32.1%
8-10 years
14.3%
6-8 years
10.7%
10+ years
7.1%
1-2 years
3.6%



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