Director of Quality Assurance and Regulatory Affairs Jobs in Bedford, IN
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.
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...
Senior Manager, Quality Assurance (M-F Day Shift)
- Bloomington, IN (14 miles from Bedford, IN)
- 18 days ago
- Bloomington, IN (14 miles from Bedford, IN)
- 18 days ago
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...
Manager, Quality Assurance (PM or Weekend Shift)
- Bloomington, IN (14 miles from Bedford, IN)
- 18 days ago
- Bloomington, IN (14 miles from Bedford, IN)
- 18 days ago
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...
- Bloomington, IN (14 miles from Bedford, IN)
- 30+ days ago
- Bloomington, IN (14 miles from Bedford, IN)
- 30+ days ago
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...
Senior Manager, Quality Assurance
- Bloomington, IN (14 miles from Bedford, IN)
- 30+ days ago
- Bloomington, IN (14 miles from Bedford, IN)
- 30+ days ago
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...
- Bloomington, IN (14 miles from Bedford, IN)
- 45+ days ago
- Bloomington, IN (14 miles from Bedford, IN)
- 45+ days ago
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...
Demographic Data for Bedford, IN
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Salary for Director of Quality Assurance and Regulatory Affairs Jobs in Bedford, IN
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Director of Quality Assurance and Regulatory Affairss in Bedford, IN 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
- Electrical Engineering
- Affirmative Action
- Quality Systems
- ISO Certified
- Implementation
- Hazardous Materials
- Quality Management
- Document Control
- Coaching
- Inspections
- ISO 13485
- Quality Management Systems
- Control Systems
- Batch Record Review
- GxP
- TrackWise
- Institutional Review Board
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Molecular Biology
- Genotyping
- Drug Development
- Biology
- Biochemistry
- Microbiology
- Biotechnology
- Good Laboratory Practice
- Laboratory Management
- Medical Device Sales
- Equipment Calibration
- FDA Regulations
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Research and Development
- Process Development
- Diagnostic
- Masters In Education
- Engineering
- Strategy Development
- Auditing
- Written Communication
- Quality Assurance
- Collaboration
- Documentation
- Inventory Management
- Regulations
- Project Management
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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