Manager of Quality Assurance and Regulatory Affairs Jobs in Texas
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 Civil, Architectural and Environmental Engineering
- Austin, TX
- 5 hours ago
- Austin, TX
- 5 hours ago
Job Posting Title: Lab Manager, Department of Civil, Architectural and Environmental Engineering ---- Hiring Department: Fariborz Maseeh Department of Civil, Architectural and Environmental...
Under supervision, the candidate will work with cell culture of primary and immortalized cells and with in vivo with mouse models....
Title: Lab Manager Employee Classification: Non-Student Help - Hourly Campus: University of North Texas Division: UNT-Provost SubDivision-Department: UNT-Ryan College of Business Department:...
Job Title Dental Lab Manager Agency Texas A&M University Health Science Center Department Comprehensive Dentistry Proposed Minimum Salary $4,180.17 monthly Job Location Dallas, Texas Job Type...
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Responsibilities: Join Thermo Fisher Scientific Inc. as a Manager, Regulatory Affairs, and play a pivotal role in...
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...
What You Bring: PhD or masters degree in Biological Sciences, Molecular biology, Biochemistry, Cell Biology, Plant Biology, Agricultural Sciences or related disciplines....
WHY UT SOUTHWESTERN? With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and...
Perform experiments using molecular biology, biochemistry, animal surgery, data analysis....
About CTMC CTMC is a pioneering biotech joint venture, formed by National Resilience and MD Anderson Cancer Center, and located in the renowned Texas Medical Center. Our mission is to accelerate...
Basic Requirements: Must be a Christian who is a member of a church that acknowledges Jesus Christ as Lord and Savior and recognizes solely the Old Testament and the New Testament as sacred...
What You'll Do ECS Limited is offering a unique opportunity for a talented and certified Assistant Lab Manager to join our Austin team. We offer opportunities for professional development with...
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Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in Texas 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
- 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
- Pharmacovigilance
- Stem Cells
- Microbiology
- Clinical Trials
- Biotechnology
- Good Laboratory Practice
- 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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