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 53 Jobs

Principal Scientist (Director) - Regulatory Affairs-CMC

  • Sacramento, CA
  • 1 day ago
  • Sacramento, CA
  • 1 day ago

Fields of study include Biology, Microbiology,or Biochemistry, Chemical, Mechanical and Electrical Engineering. **** **Required Experience and Skills:** + Demonstrated experience in a CMC regulatory...

Associate Director Regulatory Affairs

  • San Diego, CA
  • 2 days ago
  • San Diego, CA
  • 2 days ago

Education Bachelor's degree in a scientific discipline: Engineering, Biology, etc. or equivalent. Advanced degree (Master's degree or higher) preferred....

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes...

Director, Regulatory Affairs CMC

  • Foster City, CA
  • 4 days ago
  • Foster City, CA
  • 4 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...

Senior Director Regulatory Affairs, Dispensing

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

development organizations Ensure Regulatory resources are available to support inspections conducted by global regulators Qualifications: M.S. degree in a technical discipline (e.g., engineering, biology...

Sr. Manager, Quality Assurance

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

Summary Responsible for quality of assigned BD Biosciences (BDB) New Product Development (NPD) medical devices products to ensure business objectives are met with regards to on time delivery of...

Embryology Lab Manager

  • Sacramento, CA
  • 6 days ago
  • Sacramento, CA
  • 6 days ago

Education Bachelors degree in Chemistry, Biology or other related science with coursework in mathematics, statistics and physics....

Senior Regulatory Affairs Manager APAC - Diabetes Care (on-site)

  • Alameda, CA
  • 7 days ago
  • Alameda, CA
  • 7 days ago

Preferred Qualifications Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields; Masters degree...

Lab Manager

  • San Francisco, CA
  • 10 days ago
  • San Francisco, CA
  • 10 days ago

Adhere to a prescribed schedule for cleaning tissue culture rooms, including hoods, incubators, and water baths. Handle biohazard and chemical waste according to OSHA standards....

Manager, Quality Assurance

  • San Carlos, CA
  • 14 days ago
  • San Carlos, CA
  • 14 days ago

Manager, Quality Assurance in San Carlos, California Overview Manager, Quality Assurance W2 Contract-to-Hire Pay Rate: $60 - $65 per hour Location: San Carlos, CA - Hybrid Role Job Summary: We are...

Associate Director, Regulatory Affairs

  • Sacramento, CA
  • 14 days ago
  • Sacramento, CA
  • 14 days ago

California, US residents click here (. **The job details are as follows:** **Who we are** We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit...

Quality Control Lab Manager

  • Torrance, CA
  • 15 days ago
  • Torrance, CA
  • 15 days ago

Job Summary: The Quality Control Lab Manager will support the establishment and operation of our cGMP QC lab including but not limited to: Equipment receipt and installation, lab operations and...

Lab Manager

  • Palo Alto, CA
  • 16 days ago
  • Palo Alto, CA
  • 16 days ago

Lab Manager Ford Motor Company - 4.1 Palo Alto, CA Job Details Estimated: $79.8K - $108K a year 23 hours ago Benefits Paid parental leave Paid holidays Visa sponsorship Health insurance Dental...

Lab Manager

  • South San Francisco, CA
  • 18 days ago
  • South San Francisco, CA
  • 18 days ago

Adhere to a prescribed schedule for cleaning tissue culture rooms, including hoods, incubators, and water baths. Handle biohazard and chemical waste according to OSHA standards....

Director, Quality Assurance (QS&C)

  • Vista, CA
  • 18 days ago
  • Vista, CA
  • 18 days ago

A brief overview The Director of Quality Assurance (Quality Systems & Compliance), in conjunction with the VP of Quality, maintains systems to assure compliance regulatory and client requirements...

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.
The complete guide to quality control and quality assurance
Ensuring excellence: the complete guide to quality control and quality assurance is a comprehensive course design to equip professional with the essential knowledge and skill required maintain to...
Process-Validation: Essentials for Quality Assurance
Process-Validation: Essentials for Quality Assurance is a focused, practice-based course that turns (FDA PV Guidance, EU GMP Annex 15, ISO 13485, ICH Q9/Q10) validation theory into everyday plant...
Foundations of Pharmaceutical Quality Assurance and GMP
This comprehensive course covers everything you need to know about Quality Assurance (QA) in the pharmaceutical industry. You will learn the essential principles of Good Manufacturing Practices...

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.

Licensing / Certification

Required or preferred licenses and certifications for Director of Quality Assurance and Regulatory Affairs positions.



Highest Education Level

Director of Quality Assurance and Regulatory Affairss in California offer the following education background
Bachelor's Degree
35.8%
Master's Degree
31.6%
Doctorate Degree
26.0%
Associate's Degree
2.8%
Vocational Degree or Certification
1.7%
High School or GED
1.5%
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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