Director of Quality Assurance and Regulatory Affairs Jobs in Hawaii
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.
The Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) sites that manufacture active pharmaceutical ingredients...
Academic Support (Greenhouse/Aquaculture Lab Manager, 0096717T)
- Pearl City, HI
- 30+ days ago
- Pearl City, HI
- 30+ days ago
hazardous chemicals, tools, equipment, or organic matter within the campus plant facilities per OSHA and hazardous waste guidelines, which includes coordination of inventorying of chemicals with the Biology...
California, US residents click here (. **The job details are as follows:** **Who we are** We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit...
Assistant Lab Manager (Full-Time) - Maui Memorial Medical Center, Wailuku, HI
- Wailuku, HI
- 60+ days ago
- Wailuku, HI
- 60+ days ago
Job Functions, Duties, Responsibilities and Position Qualifications: We're not just a workplace - we're a Great Place to Work certified employer! Proudly certified as a Great Place to Work, we are...
Title: Lab Manager Position Number: 0096571 Hiring Unit: College of Natural & Health Sciences (CNHS)/Marine Science Location: UH Hilo Date Posted: April 2, 2025 Closing Date: April 15, 2025 Band:...
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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 Hawaii 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
- Continuous Improvement
- Affirmative Action
- Quality Systems
- Implementation
- Quality Management
- Coaching
- Inspections
- Quality Management Systems
- Batch Record Review
- GxP
- TrackWise
- Institutional Review Board
- Animal Models
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Neurobiology
- Molecular Biology
- Clinical Laboratory Operations
- Biology
- Biochemistry
- Drug Development
- Immunology
- Microbiology
- Immunohistochemistry
- Laboratory Information Management System
- Experimental Design
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Laboratory Management
- Equipment Calibration
- Medical Device Sales
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- FDA Regulations
- Research and Development
- Standard Operating Procedures
- Masters In Education
- Engineering
- Strategy Development
- Quality Control
- Auditing
- Investigation
- Education Experience
- Documentation
- Quality Assurance
- Collaboration
- Reporting
- Policy Development
- Bachelor's Degree
- Inventory Management
- Regulations
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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