Director of Quality Assurance and Regulatory Affairs Jobs
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.
Quantitative Ecology Lab Manager (SRA 3)
- California City, CA
- 7 hours ago
- California City, CA
- 7 hours ago
science, biology, limnology, or a related discipline Experience using R, particularly with data management and visualization packages, familiarity with aquatic data collection in field and laboratory...
Reviews sections of IND, NDA, and other submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements....
Client Experience Manager - Quality Assurance
- Wilmington, MA
- 12 hours ago
- Wilmington, MA
- 12 hours ago
Job Title: Client Experience Manager - Quality Assurance Location: WM USA - 37 Upton Drive Location Type: Remote Website: Group: When you join Watson-Marlow Fluid Technology Solutions, a part of...
Senior Manager, Regulatory Affairs Advertising & Promotion
- Sleepy Hollow, NY
- 14 hours ago
- Sleepy Hollow, NY
- 14 hours ago
trial recruitment materials, and familiarity with labeling regulations is desirable Ability to influence cross-functional teams and interact with senior management To be considered for this opportunity...
Research Lab Manager (Assistant Research Scientist) New York University
- New York, NY
- 16 hours ago
- New York, NY
- 16 hours ago
The Jameel Arts and Health Lab (the Lab) seeks a full-time Research Lab Manager to begin early Spring 2025. The Lab was established by the Steinhardt School at New York University, WHO Europe,...
Education : A Bachelors Degree in environmental science, chemistry, biology or a related scientific discipline is required, although a Masters Degree is preferred....
Sr. Lab Manager- Global Reliability and Test Solutions
- Rochester Hills, MI
- 22 hours ago
- Rochester Hills, MI
- 22 hours ago
Job Summary: We are seeking a highly motivated and experienced Sr. Lab Manager to lead our lab team as part of the Global Reliability & Test Solutions (GRTS) network. The ideal candidate will...
Education Requirements: Bachelors degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering or in a relevant discipline....
Research Lab Manager (Assistant Research Scientist)
- New York, NY
- 23 hours ago
- New York, NY
- 23 hours ago
The Jameel Arts and Health Lab (the Lab) seeks a full-time Research Lab Manager to begin early Spring 2025. The Lab was established by the Steinhardt School at New York University, WHO Europe,...
Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting....
Qualifications A BS in biology, chemistry, physics or closely related fields is required....
Postdoctoral Scholar & Lab Manager - Peeler Lab Apply now Job no: 535599 Work type: Faculty - Other Location: Eugene, OR Categories: Biology/Life Sciences, Research/Scientific/Grants, Chemistry, Engineering...
Preferred Qualifications Required Education: Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology or related subject)....
Senior Director Regulatory Affairs Pharmacy Automation Platform
- Durham, NC
- 1 day ago
- Durham, NC
- 1 day ago
development organizations Ensure Regulatory resources are available to support inspections conducted by global regulators Qualifications: M.S. degree in a technical discipline (e.g., engineering, biology...
biology, immunology, and animal model research Excellent organizational, analytical, and problem-solving abilities Proficiency in lab management systems and Microsoft Office Suite Knowledge of regulatory...
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Director of Quality Assurance and Regulatory Affairss 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
- Employee Development
- Affirmative Action
- Quality Systems
- ISO Certified
- Implementation
- Hazardous Materials
- Quality Management
- Document Control
- Coaching
- Inspections
- ISO 13485
- Quality Management Systems
- Control Systems
- Batch Record Review
- GxP
- TrackWise
- Animal Models
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Molecular Biology
- Genotyping
- Biology
- Drug Development
- Biochemistry
- Immunology
- 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
- Masters In Education
- Engineering
- Strategy Development
- Auditing
- Investigation
- Written Communication
- Quality Assurance
- Collaboration
- Documentation
- Inventory Management
- Regulations
- Project Management
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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