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.
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe...
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...
Provide leadership and oversight of quality assurance and food safety activities for multiple plant locations. Demonstrate thought leadership, executive maturity, business acumen, collaboration...
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 I - Neurology Washington University in St. Louis
- Saint Louis, MO
- 18 days ago
- Saint Louis, MO
- 18 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...
Who is Saint Louis University? Founded in 1818, Saint Louis University is one of the nation's oldest and most prestigious Catholic universities. SLU, which also has a campus in Madrid, Spain, is...
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 /...
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...
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...
Research Lab Manager - Neurosurgery Washington University in St. Louis
- Saint Louis, MO
- 30+ days ago
- Saint Louis, MO
- 30+ 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...
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...
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
- Verbal Communication
- Mentoring
- Quality Systems
- Implementation
- Change Control
- Coaching
- Quality Management Systems
- Batch Record Review
- GxP
- 21 CFR 820
- Assay Development
- Biomarkers
- Flow Cytometry
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Genotyping
- Next-Generation Sequencing
- Lab Safety
- Molecular Biology
- Cloning
- Clinical Laboratory Operations
- Polymerase Chain Reaction
- DNA Isolation
- Drug Development
- Biology
- Stem Cells
- Microbiology
- Biotechnology
- Clinical Trials
- Good Laboratory Practice
- Clinical Research
- Laboratory Management
- Neurology
- Oncology
- FDA Regulations
- Research and Development
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Control
- Military Background
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Research Skills
- Microsoft Office
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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