Manager of Quality Assurance and Regulatory Affairs Jobs in Illinois
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.
Overview The Director, Regulatory Affairs - Advertising & Promotion is the regulatory expert who is responsible for strategically leading functional and cross-functional partners during...
Overview The Manager, Regulatory Affairs role is responsible for creating the FDA submission package for promotional material in Veeva PromoMats, and for general system administration and...
at Jubilant Radiopharma in Chicago, Illinois, United States Job Description Jubilant HollisterStier LLC, a well-established member of the business community in Spokane, Washington, provides a...
Using an advanced level of skill, completes the following activities: Molecular Biology: DNA, RNA, Protein isolation, purification and expression Southern, Northern, Western blotting PCR, RT-PCR RNA...
SUMMARY: Manages laboratory resources to ensure safe, regulatory compliance and expeditious processing of technical information and analysis in support of site objectives. Supervises and...
Knowledge of research techniques or methods (cell biology, translation, transcription, primary cultures, microscopy, cell assays, biochemical assays, molecular biology assays)....
Research Lab Manager - Coordinated Science Lab Coordinated Science Lab The Health Care Engineering Systems Center(HCESC) at the Coordinated Science Laboratory in the Grainger College ofEngineering...
Medical Laboratory Manager Schedule: Monday-Friday, one weekend per month One night per week, holiday rotation This rural Minnesota hospital is committed to providing high-quality, personalized...
Clinical Practice, CAP/CLIA, other quality system standards Strong communication, presentation and interpersonal skills Experience leading cross-functional teams of subject matter experts Experience...
Remote WorkKnowledge of research techniques or methods (cell biology, translation, transcription, primary cultures, microscopy, cell assays, biochemical assays, molecular biology assays)....
Knowledge of research techniques or methods (cell biology, translation, transcription, primary cultures, microscopy, cell assays, biochemical assays, molecular biology assays)....
at PAREXEL International LLC in Chicago, Illinois, United States Job Description Exciting opportunity to join Parexel as an Associate/Director of Regulatory Affairs! As an Associate/Director of...
Remote WorkDescription The Lab of Manager Operations - Histology reflects the mission, vision, and values of NM, adheres to the organizations Code of Ethics and Corporate Compliance Program, and complies...
Associate Director, Quality Assurance - Remote
- Springfield, IL
- 30+ days ago
- Springfield, IL
- 30+ days ago
Associate Director, Quality Assurance - Remote Company: Merck Location: Springfield, IL Date Posted: 2/12/25, 2:27 AM Job Description Reporting to the Director of Medical Device and Combination...
The Manager, Regulatory Affairs will be responsible for managing regulatory requirements and in-market product compliance to maintain and further develop the regulatory capability of the US-based...
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Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in Illinois 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
- Safe Quality Food
- Interpersonal Skills
- Inspections
- Quality Management Systems
- Batch Record Review
- GxP
- Food Manufacturing
- 21 CFR 820
- Institutional Review Board
- Cell Biology
- Assay Development
- Transfection
- Real-Time Polymerase Chain Reaction
- Gene Therapy
- ICH Guidelines
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Polymerase Chain Reaction
- Pharmacovigilance
- Clinical Laboratory Operations
- Cell Culture
- Genotyping
- DNA Isolation
- Drug Development
- 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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