Director of Quality Assurance and Regulatory Affairs Jobs in Longmont, CO
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.
Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across...
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Highest Education Level
Director of Quality Assurance and Regulatory Affairss in Longmont, CO 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
- Mentoring
- Affirmative Action
- Quality Systems
- Implementation
- Resolution
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- GxP
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- 21 CFR 820
- Institutional Review Board
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- Standard Operating Procedures
- Product Development
- Engineering
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- Written Communication
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- Documentation
- Quality Assurance
- Collaboration
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- Education Experience
- Bachelor's Degree
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- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
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- Research Skills
- Scheduling
- Computer Skills
- Leadership
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