Manager of Quality Assurance and Regulatory Affairs Jobs in Maryland
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.
About The Position: The Research Laboratory Manager supports the Principal Investigator with the execution and maintenance of the research study, and the management of study documentation. The...
The Senior Director, Regulatory Affairs will head the Regulatory function at MaxCyte. The Senior Director, Regulatory Affairs develops and implements regulatory compliance and strategies that...
Site Name: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Collegeville TSA, USA - Maryland - Rockville Posted Date: Mar 3 2025 Job Purpose Ensure the development of appropriate...
Overview LMI is seeking an experienced Regulatory Affairs Manager to support the Office of Human and Animal Research Oversight (OHARO), Office of Human Research Oversight (OHRO) at Ft. Detrick in...
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Bethesda, MD
- 60+ days ago
- Bethesda, MD
- 60+ days ago
Experience with clinical trial assays (CTA) in drug clinical trials in communicating between Diagnostic sponsor and Drug sponsor....
Lab Manager Johns Hopkins University - 4.0 Baltimore, MD Job Details Full-time $55,800 - $97,600 a year 1 day ago Qualifications Pet care Biology Medicine ELISA Blood sampling Medication...
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Manager of Quality Assurance and Regulatory Affairss in Maryland 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
- Quality Systems
- Supplier Management
- Implementation
- Interpersonal Skills
- Inspections
- Quality Management Systems
- Batch Record Review
- GxP
- Food Manufacturing
- 21 CFR 820
- Institutional Review Board
- Cell Biology
- Assay Development
- Flow Cytometry
- Real-Time Polymerase Chain Reaction
- Transfection
- Gene Therapy
- ICH Guidelines
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Polymerase Chain Reaction
- Pharmacovigilance
- Drug Development
- Clinical Laboratory Operations
- Cell Culture
- Genotyping
- DNA Isolation
- Biochemistry
- Microbiology
- Biology
- Stem Cells
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Biotechnology
- Laboratory Management
- Validation
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Quality Control
- Investigation
- Auditing
- Written Communication
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Education Experience
- Inventory Management
- Regulations
- Policy Development
- Project Management
- Research Skills
- Microsoft Office
- Problem Solving
- Teamwork
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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