Director of Quality Assurance and Regulatory Affairs Jobs in South Carolina
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.
ANDAs, INDs, NDAs, amendments/supplements, annual reports, etc.) and thorough knowledge of FDA, EMA and ICH guidelines and regulations....
Principal Scientist (Director) - Regulatory Affairs-CMC
- Columbia, SC
- 2 days ago
- Columbia, SC
- 2 days ago
Fields of study include Biology, Microbiology,or Biochemistry, Chemical, Mechanical and Electrical Engineering. **** **Required Experience and Skills:** + Demonstrated experience in a CMC regulatory...
Associate Principal Scientist/Associate Director , Regulatory Affairs - Compliance
- Columbia, SC
- 6 days ago
- Columbia, SC
- 6 days ago
This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility for this position is to ensure...
Job Description Summary The Department Manager is responsible for the oversight of specimen collection and test performance in chemistry, hematology, serology, immunohematology, and microbiology...
Instructional Lab Manager - Department of Biological Sciences
- Clemson, SC
- 10 days ago
- Clemson, SC
- 10 days ago
Serves on Department Instrumentation Committee and coordinates equipment shared across the three buildings housing Biology and Microbiology teaching labs. 10% - Essential - Lab Safety: Serves as Department...
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...
We are the movers of the world and the makers of the future. We get up every day, roll up our sleeves and build a better world -- together. At Ford, were all a part of something bigger than...
Qualifications Education, Experience, and Licenses: Bachelors Degree in a Scientific or Engineering discipline, with exposure to Chemistry, Microbiology and/or Biology Professional quality discipline...
Who You Are: Bachelors degree in food science, Biology, Chemistry, or related discipline....
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Director of Quality Assurance and Regulatory Affairss in South Carolina 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
- Good Manufacturing Practices
- FDA Regulations
- Corrective Actions & Preventive Actions
- Research and Development
- Process Development
- Diagnostic
- Masters In Education
- Engineering
- Strategy Development
- Auditing
- Written Communication
- Quality Assurance
- Collaboration
- Documentation
- Regulations
- Inventory Management
- Project Management
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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