Director of Quality Assurance and Regulatory Affairs Jobs in Virginia
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...
Manager, Quality Assurance - Clinical Trials (Hybrid)
- Chantilly, VA
- 19 days ago
- Chantilly, VA
- 19 days ago
Apply knowledge of regulatory requirements on a daily basis including providing guidance on interpretation of, and compliance with, regulatory requirements (GCPs, CLIA), guidance, Good Clinical Practice...
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...
Lab Manager Benefits of working at VCU All full-time university staff are eligible for VCUs robust benefits package that includes: comprehensive health benefits, paid annual and holiday leave...
Lab Manager- Pharmacy Hampton University Staff The successful applicant must possess knowledge of basic laboratory techniques, provide technical support to faculty members and students as well as...
Individual must be able to learn and employ a wide variety of experimental techniques including but not limited to PCR, electrophoresis, sequencing, tissue culture, transformations, and blot analysis...
Executive Director Quality Assurance Bioanalytical and Vaccine Laboratories
- Richmond, VA
- 60+ days ago
- Richmond, VA
- 60+ days ago
decentralized clinical trial services....
Job Type Full-time Description **US Based Candidates Only** Granules Pharmaceuticals, Inc., located in Chantilly, VA was the 10th fastest growing generic pharma company in United States in 2024...
Associate Director Quality Assurance Compliance, Hopewell NJ Site
- Hopewell, VA
- 90+ days ago
- Hopewell, VA
- 90+ days ago
Core Competencies, Knowledge, and Skill Requirements Scientific degree (ideally chemistry, biology, biotechnology, pharmaceutical sciences or related)....
Who We Are and What We Do Farmer Focuss mission is to promote and protect generational family farms by shifting farm-level decision-making and chicken ownership back to farmers and empowering them...
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Director of Quality Assurance and Regulatory Affairss in Virginia 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
- ISO Certified
- Implementation
- Hazardous Materials
- Quality Management
- Document Control
- Coaching
- Inspections
- ISO 13485
- Quality Management Systems
- Batch Record Review
- GxP
- TrackWise
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Molecular Biology
- Genotyping
- Biology
- Drug Development
- Biochemistry
- Microbiology
- Biotechnology
- Good Laboratory Practice
- Laboratory Management
- Equipment Calibration
- Medical Device Sales
- FDA Regulations
- Corrective Actions & Preventive Actions
- Research and Development
- Good Manufacturing Practices
- Process Development
- Engineering
- Strategy Development
- Quality Control
- Auditing
- Investigation
- Written Communication
- Quality Assurance
- Collaboration
- Education Experience
- Documentation
- Reporting
- Bachelor's Degree
- Inventory Management
- Regulations
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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