Director of Quality Assurance and Regulatory Affairs Jobs in Texas
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.
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...
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, theres no magic formula to how we do it. Our greatest scientific solution is talented...
Sr. Manager, Regulatory Affairs Strategy - Global - Pharma
- Fort Worth, TX
- 16 days ago
- Fort Worth, TX
- 16 days ago
Job Title: Sr. Manager, Regulatory Affairs Strategy - Global - Pharma At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress,...
Ideal candidates will be proficient in cell culture and molecular biology techniques (DNA and RNA isolation, Western Blot, Co-Immunoprecipitation, Immunostaining), with a background in cardiovascular...
Assign responsibilities to manage testing Provide coaching and training to technicians on lab safety and operations Escalate quality issues to management and quality engineering team Lead 5S and efficiency...
What You Bring: PhD or masters degree in Biological Sciences, Molecular biology, Biochemistry, Cell Biology, Plant Biology, Agricultural Sciences or related disciplines....
Biology Spec-ASCP (SMB):....
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...
Research Engineering/Scientist Associate II (Lab Manager)
- Austin, TX
- 60+ days ago
- Austin, TX
- 60+ days ago
Strong technical expertise in a wide range of laboratory techniques, such as optical imaging, electrophysiology and/or molecular biology....
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
Director 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 Director of Quality Assurance and Regulatory Affairs position
- Verbal Communication
- Mentoring
- Quality Systems
- Implementation
- Change Control
- Coaching
- Quality Management Systems
- Batch Record Review
- GxP
- 21 CFR 820
- Assay Development
- Biomarkers
- Flow Cytometry
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Genotyping
- Next-Generation Sequencing
- Lab Safety
- Molecular Biology
- Cloning
- Clinical Laboratory Operations
- Polymerase Chain Reaction
- DNA Isolation
- Drug Development
- Biology
- Stem Cells
- Microbiology
- Biotechnology
- Clinical Trials
- Good Laboratory Practice
- Clinical Research
- Laboratory Management
- Neurology
- Oncology
- FDA Regulations
- Research and Development
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Control
- Military Background
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Research Skills
- Microsoft Office
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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