Director of Quality Assurance and Regulatory Affairs Jobs in Greenwood, 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.
- Indianapolis, IN (12 miles from Greenwood, IN)
- 3 days ago
- Indianapolis, IN (12 miles from Greenwood, IN)
- 3 days ago
Responsible for performing responsibilities as assigned to effectively support implementation of the Quality Management System. Will provide global quality oversight for customer complaint...
Remote Work- Avon, IN (15 miles from Greenwood, IN)
- 15 days ago
- Avon, IN (15 miles from Greenwood, IN)
- 15 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...
Labcorp is seeking a Clinical Laboratory Manager to join our team in Greenwood, IN. The Laboratory Manager will create, implement, and manage the policies, procedures and practices for optimal...
- Indianapolis, IN (12 miles from Greenwood, IN)
- 45+ days ago
- Indianapolis, IN (12 miles from Greenwood, IN)
- 45+ days ago
How You'll Add Value The Sample Preparation Services (SPS) Manager is responsible for daily processing of fresh and frozen biological samples, associated QC and characterization activities under GLP-like...
Demographic Data for Greenwood, IN
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Highest Education Level
Director of Quality Assurance and Regulatory Affairss in Greenwood, 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
- Quality Systems
- Supplier Management
- Implementation
- Safe Quality Food
- Interpersonal Skills
- Inspections
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- GxP
- Food Manufacturing
- 21 CFR 820
- Cell Biology
- Assay Development
- Real-Time Polymerase Chain Reaction
- Gene Therapy
- ICH Guidelines
- Genotyping
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- Medical Writing
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- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Clinical Trials
- Biotechnology
- Laboratory Management
- Validation
- FDA Regulations
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- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Military Background
- Quality Control
- Investigation
- Auditing
- Written Communication
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
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- Project Management
- Research Skills
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Teamwork
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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