Director of Quality Assurance and Regulatory Affairs Jobs in Valhalla, NY
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.
Associate Director, Regulatory Affairs
- Elmwood Park, NJ (21 miles from Valhalla, NY)
- 4 days ago
- Elmwood Park, NJ (21 miles from Valhalla, NY)
- 4 days ago
Read and understand current FDA guidance(s) and trends, USP general/specific DS/DP monographs, and be familiar with ICH guidelines and post-approval change guidance(s) accordingly....
- Franklin Lakes, NJ (22 miles from Valhalla, NY)
- 15 days ago
- Franklin Lakes, NJ (22 miles from Valhalla, NY)
- 15 days ago
Qualifications: Bachelors degree or advanced degree in technical area such as biology, chemistry, engineering or medical-related field and a m inimum of nine years of experience, or equivalent combination...
Clinical Lab Manager - Microbiology#25-00888 Valhalla, NY All On-site Job Description Clinical Lab Manager - Microbiology Valhalla, NY Mon-Fri 8:30am-5pm Job Summary: Under the direction of the...
Senior Manager, Regulatory Affairs Advertising & Promotion
- Sleepy Hollow, NY (3 miles from Valhalla, NY)
- 45+ days ago
- Sleepy Hollow, NY (3 miles from Valhalla, NY)
- 45+ days ago
The Senior Manager position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with experienced understanding of advertising and...
Demographic Data for Valhalla, NY
Moving to Valhalla, NY? Find some basic demographic data about Valhalla, NY 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 Valhalla, NY
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 Valhalla, NY 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
- Spectrophotometer
- Cancer Research
- Gene Therapy
- Lab Safety
- Molecular Biology
- ICH Guidelines
- Medical Affairs
- Next-Generation Sequencing
- Clinical Laboratory Operations
- Water Testing
- Biology
- Scientific Research
- Microbiology
- Drug Development
- Pharmacovigilance
- Fermentation
- Immunology
- Medical Writing
- Experimental Design
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Clinical Research
- Laboratory Management
- Medical Device Sales
- Good Manufacturing Practices
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Collections
- Strategy Development
- Quality Control
- Auditing
- Documentation
- Education Experience
- Investigation
- Collaboration
- Reporting
- Quality Assurance
- Inventory Management
- Interpersonal Skills
- Bachelor's Degree
- Policy Development
- Project Management
- Regulations
- Problem Solving
- Research Skills
- Microsoft Office
- 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 »