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.
Sr. Manager, Regulatory Affairs Strategy - Global - Pharma
- Fort Worth, TX
- 1 day ago
- Fort Worth, TX
- 1 day 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...
The Director of Quality Assurance is a key leadership role responsible for the strategic oversight and execution of the company's Quality Assurance programs. This individual will ensure that all...
Experience with lab safety audits and adhering to safety standards and protocols in order to maintain compliance. 8....
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):....
EXPERIENCE AND EDUCATION Required Education Bachelor's Degree in Biology, Chemistry, or related scientific field Must meet education and experience certification and training guidelines for equipment...
Research Engineering/Scientist Associate II (Lab Manager)
- Austin, TX
- 45+ days ago
- Austin, TX
- 45+ 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...
Qualifications: B.S. in Biology or a related scientific field is required; a Master of Science is preferred. Exceptional organizational skills and meticulous attention to detail....
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...
Job Posting Title: Lab Manager - Williamson --- Hiring Department: Population Research Center --- Position Open To: All Applicants --- Weekly Scheduled Hours: 40 --- FLSA Status: Non-Exempt ---...
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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
- Mentoring
- Quality Systems
- Implementation
- Change Control
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- 21 CFR 820
- Institutional Review Board
- Assay Development
- Flow Cytometry
- Good Clinical Practice
- Real-Time Polymerase Chain Reaction
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Genotyping
- Lab Safety
- Molecular Biology
- Cloning
- Clinical Laboratory Operations
- Cancer Biology
- Polymerase Chain Reaction
- Western Blot
- DNA Isolation
- Drug Development
- Biology
- Medical Writing
- Pharmacovigilance
- Stem Cells
- Microbiology
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Scientific Writing
- Biotechnology
- Laboratory Management
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Collections
- Quality Control
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Reporting
- Education Experience
- Bachelor's Degree
- Inventory Management
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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