Director of Quality Assurance and Regulatory Affairs Jobs in Indiana
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.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world...
EDUCATION and/or EXPERIENCE Bachelor of Science in Chemistry, Biology, Medical Technology, Engineering, or related area from an accredited four-year college or university Fifteen years related experience...
Indiana University Health is unlike any other healthcare system and we're looking for team members who share the things that matter most to us. People who are inspired by challenging and...
Paint Lab Manager for Aluminum/Metal Finishing Company
- Indianapolis, IN
- 60+ days ago
- Indianapolis, IN
- 60+ days ago
Superior Metal Technologies is stable full-service aluminum metal finishing company, specializing in high-performance architectural coatings. We are located in the East side of Indianapolis. We...
Superior Metal Technologies, LLC is seeking a detail-oriented and highly organized individual to join our Paint Department as a Paint Lab Technician/Manager. The successful candidate will be...
Job Description Overview Indiana University Health is unlike any other healthcare system and we're looking for team members who share the things that matter most to us. People who are inspired by...
About the Department At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on...
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Required or preferred licenses and certifications for Director of Quality Assurance and Regulatory Affairs positions.
Highest Education Level
Director of Quality Assurance and Regulatory Affairss in Indiana 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
- Inspections
- ISO 13485
- Quality Management Systems
- Batch Record Review
- GxP
- ICH GCP
- Assay Development
- Institutional Review Board
- Animal Models
- Spectrophotometer
- Cancer Research
- Gene Therapy
- Lab Safety
- Molecular Biology
- ICH Guidelines
- Medical Affairs
- Next-Generation Sequencing
- Clinical Laboratory Operations
- Water Testing
- Biology
- Scientific Research
- Microbiology
- Drug Development
- Pharmacovigilance
- Immunology
- Medical Writing
- Experimental Design
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Clinical Research
- Laboratory Management
- Medical Device Sales
- Good Manufacturing Practices
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Collections
- Strategy Development
- Quality Control
- Auditing
- Documentation
- Education Experience
- Investigation
- Collaboration
- Reporting
- Quality Assurance
- Inventory Management
- Interpersonal Skills
- Bachelor's Degree
- Policy Development
- Project Management
- Regulations
- Problem Solving
- Research Skills
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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