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.
Preferred Qualifications: Background and interest in mammalian cell culture, molecular biology, handling RNA, and qPCR techniques....
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Lab Manager - Infectious Disease Labs Department: Pathology Lab Job Description: New to OU Health? Ask your recruiter about our competitive wages and total rewards package including a sign-on...
Minimum qualifications: Bachelor's degree in Electrical Engineering, Computer Engineering, Computer Science, or a related field, or equivalent practical experience. 1 year of experience with...
Preferred Qualifications: Bachelor's degree in Chemistry, Biology, Pharmaceutical Science or a related field....
years relevant clinical research experience in a combination of research site, biotech or pharma, or CRO experience Oncology clinical trials or oncology clinical experience Extensive knowledge of ICH...
years relevant clinical research experience in a combination of research site, biotech or pharma, or CRO experience Oncology clinical trials or oncology clinical experience Extensive knowledge of ICH...
Associate Director, Quality Assurance
- South San Francisco, CA
- 3 days ago
- South San Francisco, CA
- 3 days ago
As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility...
: Bachelor's degree required; advanced degree in life sciences preferred. 7+ years or equivalent relevant experience in regulatory affairs in the biopharmaceutical industry Strong understanding of ICH...
Quality Assurance: Supervise regulatory aspects of quality systems, including compliance with Good Clinical Practices (GCP), and General Data Protection Regulation (GDPR)....
School Diploma or equivalent BS Degree in Chemistry or BS Degree in Bacteriology Mid-level operator certification in the State in which the project is located Knowledge of the principles of chemistry, biology...
Salary Statement Estimated Starting Salary Range: USD $84,000.00/Yr. - USD $139,950.00/Yr. Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant,...
Water Quality & Regulatory Affairs Manager Imagine yourself Doing meaningful work that makes an everyday impact on the world around you. Owning your ambition and fueling your career growth....
Minimum Requirements Bachelor s Degree in Biology, Chemistry, or related field from an accredited college or university....
Job Order Number: DE9874268 Job Title: Director Regulatory Affairs Labeling Company: ACADIA PHARMACEUTICALS INC Location: Princeton, NJ Salary: Education: Bachelor's Degree Experience: 7 years...
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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
- Quality Systems
- Implementation
- Change Control
- Inspections
- ISO 13485
- Quality Management Systems
- Batch Record Review
- GxP
- ICH GCP
- Assay Development
- Institutional Review Board
- Animal Models
- Spectrophotometer
- Cancer Research
- Gene Therapy
- Lab Safety
- ICH Guidelines
- Medical Affairs
- Next-Generation Sequencing
- Clinical Laboratory Operations
- Water Testing
- Biology
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- Drug Development
- Pharmacovigilance
- Fermentation
- Immunology
- Medical Writing
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- Biotechnology
- Good Laboratory Practice
- Clinical Trials
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- Medical Device Sales
- Good Manufacturing Practices
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
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- Strategy Development
- Quality Control
- Auditing
- Documentation
- Education Experience
- Investigation
- Collaboration
- Reporting
- Quality Assurance
- Inventory Management
- Interpersonal Skills
- Bachelor's Degree
- Policy Development
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- Problem Solving
- Research Skills
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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