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.
The Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) sites that manufacture active pharmaceutical ingredients...
LabCorp is seeking a Clinical Laboratory Manager to join our team at Ascension Providence Hospital in Waco, TX. This position will be responsible for overseeing the operations and administration...
Job Posting Title: Lab Manager (Lockman) ---- Hiring Department: Population Research Center ---- Position Open To: All Applicants ---- Weekly Scheduled Hours: 40 ---- FLSA Status: Exempt ----...
Posting Number S06449P Position Title Lab Manager Functional Title Department Speech Language Hearing Salary Range $65,000 - $70,000, DOQ Pay Basis Monthly Position Status Regular full-time...
Under supervision, the candidate will work with cell culture of primary and immortalized cells and with in vivo with mouse models....
Biology Spec-ASCP (SMB):....
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...
Lab Manager, Department of Civil, Architectural and Environmental Engineering
- Austin, TX
- 45+ days ago
- Austin, TX
- 45+ 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....
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:...
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...
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....
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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
- Continuous Improvement
- Affirmative Action
- Quality Systems
- ISO Certified
- Implementation
- Hazardous Materials
- Quality Management
- Document Control
- Coaching
- Inspections
- ISO 13485
- Quality Management Systems
- Batch Record Review
- GxP
- TrackWise
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Molecular Biology
- Genotyping
- Biology
- Drug Development
- Biochemistry
- Microbiology
- Biotechnology
- Good Laboratory Practice
- Laboratory Management
- Equipment Calibration
- Medical Device Sales
- FDA Regulations
- Corrective Actions & Preventive Actions
- Research and Development
- Good Manufacturing Practices
- Process Development
- Engineering
- Strategy Development
- Quality Control
- Auditing
- Investigation
- Written Communication
- Quality Assurance
- Collaboration
- Education Experience
- Documentation
- Reporting
- Bachelor's Degree
- Inventory Management
- Regulations
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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