Director of Quality Assurance and Regulatory Affairs Jobs
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.
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Certified Group is a leading North American provider of laboratory testing, regulatory consulting, and certification & audit services. The Certified Group of companies includes Food Safety Net...
PREFERRED QUALIFICATIONS Patience, knowledge and experience to teach principal laboratory operations, theories, molecular biology techniques, tissue culture operations and techniques, and laboratory...
Associate Director, Quality Assurance Vendor Management
- Watertown, MA
- 11 hours ago
- Watertown, MA
- 11 hours ago
biology, specifically heme biosynthesis and iron homeostasis....
Remote WorkSenior Quality Assurance Manager/Quality Assurance Director
- Hillsboro, OR
- 13 hours ago
- Hillsboro, OR
- 13 hours ago
The Position This role is an integral part of our Individualized and Cell Therapy Quality team, dedicated to ensuring that our products and services meet the highest standards of quality and...
About the Role >>> Director, Regulatory Affairs CMC As the Director, Regulatory Affairs CMC, reporting to the Senior Director, Regulatory Affairs CMC, you will be responsible for developing and...
Overview Do you want to join a team that's changing the world? Do you have a strong background as a Quality Lab Manager? Then we're looking for you! Check out the job description and apply now!...
Who We Are Vial is a hyper-scalable biotech company advancing programs into the clinic by leveraging dramatically cheaper trials and computationally designed therapeutics. Our mission is to...
Career Category Regulatory Job Description HOW MIGHT YOU DEFY IMAGINATION? Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How...
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Overview The Manager, Regulatory Affairs role is responsible for creating the FDA submission package for promotional material in Veeva PromoMats, and for general system administration and...
at Jubilant Radiopharma in Chicago, Illinois, United States Job Description Jubilant HollisterStier LLC, a well-established member of the business community in Spokane, Washington, provides a...
Title: Senior Director Regulatory Affairs SUMMARY: A leading biopharmaceutical company is seeking a Sr. Director of Regulatory Affairs. This role involves developing and implementing global...
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Director of Quality Assurance and Regulatory Affairss 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
- Quality Systems
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