Director of Quality Assurance and Regulatory Affairs Jobs in Bothell, WA

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.

1-3 of 3 Jobs

Director, Regulatory Affairs

  • Bothell, WA
  • 23 days ago
  • Bothell, WA
  • 23 days ago

Director, Regulatory Affairs Location US-WA-Bothell ID 2025-1489 Category Quality Assurance/Regulatory Affairs Position Type Full Time Work Model Onsite Company Overview Verathon is a global...

Chemistry/Physics Lab Manager - Instruction And Classroom Support Technician 4

  • Lynnwood, WA (5 miles from Bothell, WA)
  • 45+ days ago
  • Lynnwood, WA (5 miles from Bothell, WA)
  • 45+ days ago

Edmonds College is committed to diversity, equity and inclusion. The college values its talented, diverse workforce and seeks to attract, hire, and support employees who consistently and actively...

Chemistry/Physics Lab Manager - Instruction & Classroom Support Technician 4 (C)

  • Lynnwood, WA (5 miles from Bothell, WA)
  • 45+ days ago
  • Lynnwood, WA (5 miles from Bothell, WA)
  • 45+ days ago

Position Overview Edmonds College is committed to diversity, equity and inclusion. The college values its talented, diverse workforce and seeks to attract, hire, and support employees who...

Demographic Data for Bothell, WA

Moving to Bothell, WA? Find some basic demographic data about Bothell, WA below.


Local
National
136,854
2,954
Medium/Lg

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...
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...

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Salary for Director of Quality Assurance and Regulatory Affairs Jobs in Bothell, WA

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 Bothell, WA 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 Bothell, WA
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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