Director of Quality Assurance and Regulatory Affairs Jobs in Ohio
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.
Labcorp is seeking a Clinical Laboratory Manager, Microbiology to join our team in Dublin, OH. This position will be responsible for overseeing the operations and administration of the clinical...
The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in...
Kelly Science & Clinical is seeking a Director - Quality Assurance southeast of Cleveland, OH. Direct Hire Relocation assistance provided We are seeking a Quality Assurance professional with...
Kelly Science & Clinical is seeking a Director Quality Assurance southeast of Cleveland, OH. Direct Hire Relocation assistance provided We are seeking a Quality Assurance professional with...
Job Title: Associate Director, Regulatory Affairs Location: Columbus, OH Job Type: Full time Req ID: 8428 About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma...
Director, Quality Assurance/Regulatory Affairs, Hoxworth Blood Center University of Cincinnati
- Cincinnati, OH
- 30+ days ago
- Cincinnati, OH
- 30+ days ago
Required Education Bachelor's Degree in Medical Technology, Biology, Chemistry, or related field....
Director, Quality Assurance/Regulatory Affairs, Hoxworth Blood Center
- Cincinnati, OH
- 30+ days ago
- Cincinnati, OH
- 30+ days ago
Required Education Bachelor's Degree in Medical Technology, Biology, Chemistry, or related field....
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...
Responsibilities include: Teaching lecture and/or lab for General Chemistry and a one-semester General, Organic, and Biochemistry course for allied health majors Maintaining the inventory of the chemistry...
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Director of Quality Assurance and Regulatory Affairss in Ohio 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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