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.
The Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) sites that manufacture active pharmaceutical ingredients...
Molecular Lab Manager - Genomics and Bioinformatics Facility
- Clemson, SC
- 13 days ago
- Clemson, SC
- 13 days ago
and faculty to carryout genomic and molecular biology experiments and protocols....
Description Senior Director of Regulatory Affairs Corporate Statement Nephron Pharmaceuticals Corporation is a privately owned global leader in the manufacturing of generic drug products,...
Job Description Summary The Department Manager is responsible for the oversight of specimen collection and test performance in chemistry, hematology, serology, immunohematology, and microbiology...
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
- Quality Systems
- Implementation
- Quality Management
- Coaching
- Inspections
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- Batch Record Review
- GxP
- TrackWise
- ICH GCP
- Institutional Review Board
- Animal Models
- Spectrophotometer
- Gene Therapy
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- ICH Guidelines
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- Neurobiology
- Molecular Biology
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- Scientific Research
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- Biochemistry
- Drug Development
- Immunology
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- Immunohistochemistry
- Medical Writing
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- Biotechnology
- Good Laboratory Practice
- Clinical Trials
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- Equipment Calibration
- Medical Device Sales
- Good Manufacturing Practices
- FDA Regulations
- Research and Development
- Standard Operating Procedures
- General Repair
- Masters In Education
- Engineering
- Strategy Development
- Quality Control
- Auditing
- Investigation
- Written Communication
- Education Experience
- Documentation
- Quality Assurance
- Collaboration
- Interpersonal Skills
- Reporting
- Policy Development
- Bachelor's Degree
- Inventory Management
- Regulations
- Project Management
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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