Director of Quality Assurance and Regulatory Affairs Jobs in New York City, 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.
This is a full time, 18 month term position (expected to start in July 2025 and last through December 2026) Skills, Qualifications & Requirements: Required Qualifications: Undergraduate degree in biology...
Lab Manager - Resetarits Lab Barnard College
- New York, NY (2 miles from New York City, NY)
- 4 days ago
- New York, NY (2 miles from New York City, NY)
- 4 days ago
This is a full time, 18 month term position (expected to start in July 2025 and last through December 2026) Skills, Qualifications & Requirements: Required Qualifications: Undergraduate degree in biology...
- New York, NY (2 miles from New York City, NY)
- 6 days ago
- New York, NY (2 miles from New York City, NY)
- 6 days ago
This is a full time, 18 month term position (expected to start in July 2025 and last through December 2026) Skills, Qualifications & Requirements: Required Qualifications: Undergraduate degree in biology...
Senior Manager (Director), Regulatory Affairs & Pharmacovigilance, USA
- New York, NY (2 miles from New York City, NY)
- 6 days ago
- New York, NY (2 miles from New York City, NY)
- 6 days ago
About myTomorrows myTomorrows is a global health tech company dedicated to breaking down barriers for patients seeking treatment options. We strive to enable earlier and better treatment access by...
Associate Director of Regulatory Affairs
- New York, NY (2 miles from New York City, NY)
- 6 days ago
- New York, NY (2 miles from New York City, NY)
- 6 days ago
More About Recursion Recursion is a clinical stage TechBio company leading the space by decoding biology to industrialize drug discovery....
- Parsippany, NJ (22 miles from New York City, NY)
- 11 days ago
- Parsippany, NJ (22 miles from New York City, NY)
- 11 days ago
Who we are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across...
Associate Manager, Quality Assurance (Visual Inspection)
- New York, NY (2 miles from New York City, NY)
- 15 days ago
- New York, NY (2 miles from New York City, NY)
- 15 days ago
to remove jewelry, make-up and nail adornments when wearing cleanroom attire To be considered for this role you must hold a BA / BS degree in a life sciences discipline or related field (chemistry, biology...
Director, Regulatory Affairs Global Labeling
- Parsippany, NJ (22 miles from New York City, NY)
- 18 days ago
- Parsippany, NJ (22 miles from New York City, NY)
- 18 days ago
Gilead Sciences, Inc. Director, Regulatory Affairs Global Labeling in Parsippany , New Jersey At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled...
Senior Manager, Regulatory Affairs, Growth Markets
- Nutley, NJ (10 miles from New York City, NY)
- 18 days ago
- Nutley, NJ (10 miles from New York City, NY)
- 18 days ago
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisais human health care (hhc) mission. Were a growing...
Director, Regulatory Affairs - 618095
- Florham Park, NJ (21 miles from New York City, NY)
- 20 days ago
- Florham Park, NJ (21 miles from New York City, NY)
- 20 days ago
Support the Global Therapeutic Area Lead (GTAL), Regulatory Affairs (Senior Director) in developing and executing regulatory strategies for antimicrobial/ antifungal programs globally or within...
Senior Manager of Quality Assurance
- Livingston, NJ (17 miles from New York City, NY)
- 30+ days ago
- Livingston, NJ (17 miles from New York City, NY)
- 30+ days ago
Company: Kelly Services Location: Livingston, NJ Career Level: Mid-Senior Level Industries: Recruitment Agency, Staffing, Job Board Description Kelly Science is seeking a Senior Manager of Quality...
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Highest Education Level
Director of Quality Assurance and Regulatory Affairss in New York City, 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
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- 21 CFR 820
- Institutional Review Board
- Assay Development
- Flow Cytometry
- Good Clinical Practice
- Real-Time Polymerase Chain Reaction
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Genotyping
- Lab Safety
- Molecular Biology
- Cloning
- Clinical Laboratory Operations
- Cancer Biology
- Polymerase Chain Reaction
- Western Blot
- DNA Isolation
- Drug Development
- Biology
- Medical Writing
- Pharmacovigilance
- Stem Cells
- Microbiology
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Scientific Writing
- Biotechnology
- Laboratory Management
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Collections
- Quality Control
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Reporting
- Education Experience
- Bachelor's Degree
- Inventory Management
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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