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.
Between $95k and $105k Per Year Position range in Missouri $60k - $134k Per Year Quality Lab Manager ACTalent, Inc. Occupation: Management Occupations Location: Saint Joseph, MO - 64501 Positions...
Job Summary The Lab Manager for the Microscopy & Histology Core Facility will perform the various tasks required for receiving, processing, and preparing research specimens for microscopic /...
Who is Saint Louis University? Founded in 1818, Saint Louis University is one of the nations oldest and most prestigious Catholic universities. SLU, which also has a campus in Madrid, Spain, is...
Gpac has an exciting opportunity for a Quality Director position in KY. The company produces sliced meat for one of the largest big-box stores in America. This plant operates 24/7 across three...
Gpac has an exciting opportunity for a Quality Director position in KY. The company produces sliced meat for one of the largest big-box stores in America. This plant operates 24/7 across three...
The lab manager is responsible for preparation of materials for introductory biology labs, managing equipment repairs/maintenance agreements, and ensuring proper allocation of resources for the...
Quality Assurance Manager Hillyard, Inc. is currently taking applications for Quality Assurance Manager for our Quality team in St. Joseph, MO. Do you have Bachelors Degree in Chemistry or...
Manages, validates and maintains documentation of quality control testing as required by regulatory bodies, including but not limited to, good clinical practice, competency assessment and documentation...
Manager Quality Assurance - Neurology Washington University in St. Louis
- Saint Louis, MO
- 30+ days ago
- Saint Louis, MO
- 30+ days ago
Manages, validates and maintains documentation of quality control testing as required by regulatory bodies, including but not limited to, good clinical practice, competency assessment and documentation...
Manages, validates and maintains documentation of quality control testing as required by regulatory bodies, including but not limited to, good clinical practice, competency assessment and documentation...
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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
- English
- Quality Systems
- Supplier Management
- Distribution
- Implementation
- Resolution
- Safe Quality Food
- Coaching
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- Food Manufacturing
- 21 CFR 820
- Assay Development
- Real-Time Polymerase Chain Reaction
- Gene Therapy
- ICH Guidelines
- Genotyping
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Drug Discovery
- Pharmacovigilance
- Clinical Laboratory Operations
- DNA Isolation
- Drug Development
- Medical Writing
- Microbiology
- Biology
- Immunology
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Clinical Trials
- Biotechnology
- Laboratory Management
- FDA Regulations
- Medical Device Sales
- Good Manufacturing Practices
- Corrective Actions & Preventive Actions
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Military Background
- Troubleshooting
- Quality Control
- Investigation
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Inventory Management
- Regulations
- Teaching
- Policy Development
- Project Management
- Research Skills
- Microsoft Office
- Problem Solving
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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