Manager of Quality Assurance and Regulatory Affairs Jobs in District of Columbia
A Manager of Quality Assurance and Regulatory Affairs in the biotechnology industry is responsible for ensuring that all products and services meet required standards and regulations. They ensure compliance with local, national, and international regulatory requirements, oversee quality control processes, and manage audits and inspections. This role also involves creating and implementing policies and procedures to enhance product quality, efficiency, and safety. They also play a crucial role in the product development process, advising on regulatory requirements and ensuring that compliance is maintained throughout the lifecycle of a product.
Skills required for this role include excellent attention to detail, strong organizational and leadership skills, and in-depth knowledge of regulatory standards and quality control methods. In addition, they should have excellent problem-solving skills, the ability to work under pressure, and strong communication skills. They should also have a strong understanding of biotechnology principles and processes. Certifications such as Certified Quality Auditor (CQA), Certified Quality Manager (CQM), or Regulatory Affairs Certification (RAC) are often required. Prior roles that can lead to a Manager of Quality Assurance and Regulatory Affairs include Quality Assurance Specialist, Regulatory Affairs Associate, and Quality Control Supervisor.
Lab Manager, Department of Psychology - Georgetown University College of Arts & Sciences
- Washington, DC
- 5 days ago
- Washington, DC
- 5 days ago
Georgetown University comprises two unique campuses in the nation's capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just...
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe...
Regulatory Affairs Manager Combination Products
- Washington, DC
- 18 days ago
- Washington, DC
- 18 days ago
HOW MIGHT YOU DEFY IMAGINATION? Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already...
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Washington, DC
- 18 days ago
- Washington, DC
- 18 days ago
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely...
The Talent Acquisition department hires qualified candidates to fill positions which contribute to the overall strategic success of Howard University. Hiring staff for fit makes significant...
Lab Manager - Georgetown University College of Arts & Sciences Georgetown University
- Washington, DC
- 30+ days ago
- Washington, DC
- 30+ days ago
Lab Manager - Georgetown University College of Arts & Sciences Georgetown University comprises two unique campuses in the nation's capital. With the Hilltop Campus located in the heart of the...
Lab Manager - Georgetown University College of Arts & Sciences
- Washington, DC
- 30+ days ago
- Washington, DC
- 30+ days ago
Georgetown University comprises two unique campuses in the nations capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just...
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Manager of Quality Assurance and Regulatory Affairss in District of Columbia offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Quality Assurance and Regulatory Affairs position
- Verbal Communication
- Mentoring
- Quality Systems
- Change Control
- Coaching
- Quality Management Systems
- Batch Record Review
- GxP
- TrackWise
- Institutional Review Board
- Assay Development
- Biomarkers
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Genotyping
- Cell Culture
- Molecular Biology
- Cloning
- Polymerase Chain Reaction
- Cancer Biology
- DNA Isolation
- Drug Development
- Biology
- Stem Cells
- Microbiology
- Clinical Trials
- Good Laboratory Practice
- Biotechnology
- Clinical Research
- Laboratory Management
- Neurology
- Oncology
- FDA Regulations
- Research and Development
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Medical Terminology
- Engineering
- Strategy Development
- Quality Control
- Military Background
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Regulations
- Policy Development
- Problem Solving
- Research Skills
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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