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.
We are the movers of the world and the makers of the future. We get up every day, roll up our sleeves and build a better world -- together. At Ford, we're all a part of something bigger than...
Histology - Lab Manager Saint Louis University
- Saint Louis, MO
- 8 days ago
- Saint Louis, MO
- 8 days ago
JOB SUMMARY The Lab Manager for the Histology Core Facility will perform the various tasks required for receiving, processing, and preparing research specimens for histology examination, analysis,...
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...
(Contractor) Senior Manager Regulatory Affairs
- Saint Louis, MO
- 8 days ago
- Saint Louis, MO
- 8 days ago
Contractor) Senior Manager Regulatory Affairs Curium Pharma United States, Missouri, St. Louis 111 West Port Plaza Drive (Show on map) Jun 03, 2025 (Contractor) Senior Manager Regulatory Affairs...
Seeking a Senior Manager Regulatory Affairs for contract position focused on new chemical entity submissions and existing product management. Requirements: BS Degree in Chemistry, Pharmacy,...
Job Level: Technical Leadership-T2 Job Description: Being part of the Royal Canin Regulatory Affairs department, specifically within the Global Market Access Strategy team, this role is essential...
Salary Not Available Position range in Kansas City, MO-KS Metropolitan Statistical Area $122k - $0k Per Year Executive Director, Regulatory Affairs Travere Therapeutics Occupation: Chief...
Provide leadership and oversight of quality assurance and food safety activities for multiple plant locations. Demonstrate thought leadership, executive maturity, business acumen, collaboration...
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 The Roland Lab is seeking an enthusiastic Research Lab Manager to join our study of brain networks in development and pathological conditions. Our work...
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Highest Education Level
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
- Quality Management
- Change Control
- Inspections
- Quality Management Systems
- Batch Record Review
- Internal Audits
- GxP
- ASQ Certified Quality Auditor
- TrackWise
- Institutional Review Board
- ICH GCP
- Assay Development
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Molecular Biology
- Genotyping
- Next-Generation Sequencing
- Polymerase Chain Reaction
- Drug Development
- Western Blot
- Biochemistry
- Biology
- Pharmacovigilance
- Immunology
- Microbiology
- Scientific Writing
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Clinical Research
- Laboratory Management
- Medical Device Sales
- Equipment Calibration
- Good Manufacturing Practices
- FDA Regulations
- Research and Development
- Standard Operating Procedures
- General Repair
- Product Development
- Engineering
- Strategy Development
- Quality Control
- Investigation
- Auditing
- Written Communication
- Collaboration
- Documentation
- Quality Assurance
- Interpersonal Skills
- Bachelor's Degree
- Reporting
- Regulations
- Inventory Management
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Research Skills
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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