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.
Scheduled Hours 40 Position Summary Serves as quality and safety leader for department's Neuromuscular Clinical Laboratory ensuring the effectiveness and proper execution of procedures, processes...
Manager Quality Assurance I - Neurology Washington University in St. Louis
- Saint Louis, MO
- 2 days ago
- Saint Louis, MO
- 2 days ago
Scheduled Hours 40 Position Summary Serves as quality and safety leader for departmentas Neuromuscular Clinical Laboratory ensuring the effectiveness and proper execution of procedures, processes...
Minimum Qualifications Bachelor's degree in biology, biomedical sciences, or a related field Minimum of 3 years of hands-on experience in histology and microscopy....
Minimum Qualifications Bachelors degree in biology, biomedical sciences, or a related field Minimum of 3 years of hands-on experience in histology and microscopy....
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...
Scheduled Hours 40 Position Summary Serves as quality and safety leader for department's Neuromuscular Clinical Laboratory ensuring the effectiveness and proper execution of procedures, processes...
Research Lab Manager - Neurosurgery Washington University in St. Louis
- Saint Louis, MO
- 24 days ago
- Saint Louis, MO
- 24 days ago
Scheduled Hours 40 Position Summary The Roland Lab is seeking an enthusiastic Research Lab Manager to join our study of brain networks in development and pathological conditions. Our work...
Scheduled Hours 40 Position Summary The Roland Lab is seeking an enthusiastic Research Lab Manager to join our study of brain networks in development and pathological conditions. Our work...
discipline * Master's or PhD in Chemistry, Biology, or a related scientific discipline preferred * Over 10 years of laboratory experience, or a bachelor's degree with 8 years of related experience,...
Scheduled Hours 40 Position Summary Serves as quality and safety leader for departments Neuromuscular Clinical Laboratory ensuring the effectiveness and proper execution of procedures, processes...
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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
- Quality Systems
- Implementation
- Change Control
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- 21 CFR 820
- Institutional Review Board
- Assay Development
- Flow Cytometry
- Good Clinical Practice
- Real-Time Polymerase Chain Reaction
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Genotyping
- Lab Safety
- Molecular Biology
- Cloning
- Clinical Laboratory Operations
- Cancer Biology
- Polymerase Chain Reaction
- Western Blot
- DNA Isolation
- Drug Development
- Biology
- Medical Writing
- Pharmacovigilance
- Stem Cells
- Microbiology
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Scientific Writing
- Biotechnology
- Laboratory Management
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Collections
- Quality Control
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Reporting
- Education Experience
- Bachelor's Degree
- Inventory Management
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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