Director of Quality Assurance and Regulatory Affairs Jobs in Missouri
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.
trial data and critical issue management based on current registration requirements and applicable industry standards....
The Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) sites that manufacture active pharmaceutical ingredients...
Principal Scientist (Director) - Regulatory Affairs-CMC
- Jefferson City, MO
- 13 days ago
- Jefferson City, MO
- 13 days ago
Fields of study include Biology, Microbiology,or Biochemistry, Chemical, Mechanical and Electrical Engineering. **** **Required Experience and Skills:** + Demonstrated experience in a CMC regulatory...
Histology - Lab Manager Saint Louis University
- Saint Louis, MO
- 30+ days ago
- Saint Louis, MO
- 30+ days ago
MINIMUM QUALIFICATIONS Bachelors degree in biology, biomedical sciences, or a related field Minimum of 3 years of hands-on experience in histology....
MINIMUM QUALIFICATIONS Bachelors degree in biology, biomedical sciences, or a related field Minimum of 3 years of hands-on experience in histology....
Other duties may be assigned Minimum Requirements: Education and Experience Bachelor of Science in Food Science, Biology, Chemistry or Chemical Engineering Master of Science in Food Science or Microbiology...
Skills Molecular Biology Techniques: Skills in techniques such as PCR, Western blotting, ELISA, immunohistochemistry, and gene expression analysis to study molecular changes in response to light pollution...
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Director of Quality Assurance and Regulatory Affairss in Missouri 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
- Continuous Improvement
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- Quality Systems
- Implementation
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- Batch Record Review
- GxP
- TrackWise
- Institutional Review Board
- Animal Models
- Spectrophotometer
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- Neurobiology
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- Clinical Trials
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- Medical Device Sales
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- Good Manufacturing Practices
- Process Development
- Standard Operating Procedures
- Engineering
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- Auditing
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- Written Communication
- Education Experience
- Quality Assurance
- Collaboration
- Documentation
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- Bachelor's Degree
- Inventory Management
- Regulations
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- Research Skills
- Staff Supervision
- Organization
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