Director of Quality Assurance and Regulatory Affairs Jobs in Columbus, OH
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.
Executive Director, Regulatory Affairs
- Grove City, OH (17 miles from Columbus, OH)
- 1 day ago
- Grove City, OH (17 miles from Columbus, OH)
- 1 day ago
Department:107000 RegulatoryLocation:USA- RemoteBe a part of a global team that is inspired to make a difference in the lives of people living with rare disease.At Travere Therapeutics, we...
Walmart (USA) Area Manager, Quality Assurance/Systems in Groveport , Ohio Position Summary... What you'll do... Implements the business plan for assigned area of responsibility by communicating...
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...
Essential Skills Experience in life science, biotechnology, or molecular biology. Proficiency in GMP, FDA, and quality assurance standards. Relevant four-year degree, Master's, or PhD preferred....
- Dublin, OH (6 miles from Columbus, OH)
- 30+ days ago
- Dublin, OH (6 miles from Columbus, OH)
- 30+ days ago
Labcorp is seeking a Clinical Laboratory Manager to join our team in Dublin, OH. This position will be responsible for overseeing the operations and administration of the clinical laboratory...
Demographic Data for Columbus, OH
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Highest Education Level
Director of Quality Assurance and Regulatory Affairss in Columbus, OH 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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