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.
Current studies employ molecular biology (PCRs, cloning), cell biology/biochemistry (Cell culture, protein work), animal models (mouse models; tumor xenografts, genotyping) combined with unbiased metabolomics...
What You'll Do ECS Limited is offering a unique opportunity for a talented and certified Assistant Concrete Lab Manager to join our Austinteam. We offer opportunities for professional development...
41054BR** **Extended Job Title:** Research Lab Manager **Position Description:** Key personnel that will assist in conducting meaningful research to assist faculty in teaching and research...
Lab Manager, Department of Civil, Architectural and Environmental Engineering
- Austin, TX
- 30+ days ago
- Austin, TX
- 30+ days 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....
Assisting faculty/doctoral students with applications to the Institutional Review Board....
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...
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...
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...
Demographic Data for Texas
Moving to Texas? Find some basic demographic data about Texas below.
Director of Quality Assurance and Regulatory Affairs Online Courses and Training Opportunities
Title Synonyms
Users interested in this job title also searched for the following job titles
Salary for Director of Quality Assurance and Regulatory Affairs Jobs in Texas
Required or preferred licenses and certifications for Director of Quality Assurance and Regulatory Affairs positions.
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
- Quality Management
- Change Control
- Inspections
- Quality Management Systems
- Batch Record Review
- Internal Audits
- GxP
- ASQ Certified Quality Auditor
- TrackWise
- Institutional Review Board
- ICH GCP
- Assay Development
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Molecular Biology
- Genotyping
- Next-Generation Sequencing
- Polymerase Chain Reaction
- Drug Development
- Biochemistry
- Biology
- Pharmacovigilance
- Immunology
- Medical Writing
- Microbiology
- Scientific Writing
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Clinical Research
- Laboratory Management
- Medical Device Sales
- Equipment Calibration
- Good Manufacturing Practices
- FDA Regulations
- Research and Development
- Standard Operating Procedures
- General Repair
- Product Development
- Engineering
- Strategy Development
- Quality Control
- Investigation
- Auditing
- Written Communication
- Collaboration
- Documentation
- Quality Assurance
- Interpersonal Skills
- Bachelor's Degree
- Reporting
- Regulations
- Inventory Management
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Research Skills
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
Other Career Titles
Here are some other career titles that require similar skills
Director of Quality Assurance and Regulatory Affairs Related Career Advice Articles
4 Biotech Opportunities & Career Paths With High Growth Potential
Biotechnology is an emerging segment of the employment market with opportunities spanning healthcare, biopharmaceuticals, agriculture, industry, and academia. If you have a thirst for innovation, this career path might be right for you!
Read article »