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.
About QED Therapeutics & BridgeBio Pharma QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly...
Associate Manager, Quality Assurance (Visual Inspection)
- East Greenbush, NY
- 2 hours ago
- East Greenbush, NY
- 2 hours ago
We are currently looking to fill an Associate Manager QA (Visual Inspection) position. This position will be responsible for supervising a team of QA employees and their prospective area(s) and/or...
Lab Manager - Georgetown University College of Arts & Sciences Georgetown University
- Washington, DC
- 5 hours ago
- Washington, DC
- 5 hours ago
Lab Manager - Georgetown University College of Arts & Sciences Georgetown University comprises two unique campuses in the nation's capital. With the Hilltop Campus located in the heart of the...
Canopy Life Sciences is a well-respected vendor & partner in the life sciences industry, assisting pharmaceutical and life sciences clients in various functional areas of expertise. Our culture is...
Prepare IDE submissions to support investigational use and provide regulatory support for clinical studies ensuring compliance with Good Clinical Practice....
Director, Regulatory Affairs Global Labeling
- Parsippany, NJ
- 19 hours ago
- Parsippany, NJ
- 19 hours 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...
BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be...
Lab Manager - Georgetown University College of Arts & Sciences
- Washington, DC
- 22 hours ago
- Washington, DC
- 22 hours ago
Georgetown University comprises two unique campuses in the nations capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just...
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...
General Description: BeiGene is seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual leads biologics regulatory CMC team based...
Conducts immunohistochemistry, microscopy, and molecular biology techniques such as sequencing and PCR....
Experience overseeing publishing vendors preferred #LI-AT1 skills: GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Briefing Documents, Submissions Equal Opportunity Employer:...
Remote WorkRegulatory Affairs Director - Inflammation and Rare Disease
- Thousand Oaks, CA
- 1 day ago
- Thousand Oaks, CA
- 1 day ago
Career Category Regulatory Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared missionto serve...
Director, Regulatory Affairs Business Operations
- Basking Ridge, NJ
- 2 days ago
- Basking Ridge, NJ
- 2 days ago
This role resides in the Global Development area of Regulatory Affairs, Global Patient Safety and Development Quality (RA, GPS and DQ) and the Director of Strategy Planning and Operations role...
Job Summary Salary Range: $165,000 to $200,000 Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, abilities and...
Director of Quality Assurance and Regulatory Affairs Online Courses and Training Opportunities
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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
- Document Management
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- Institutional Review Board
- Cell Biology
- Flow Cytometry
- Transfection
- Real-Time Polymerase Chain Reaction
- Gene Therapy
- ICH Guidelines
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Pharmacovigilance
- Cloning
- Drug Development
- Clinical Laboratory Operations
- Genotyping
- Polymerase Chain Reaction
- DNA Isolation
- Western Blot
- Biology
- Stem Cells
- Microbiology
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Scientific Writing
- Biotechnology
- Laboratory Management
- FDA Regulations
- Medical Device Sales
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Military Background
- Quality Control
- Investigation
- Auditing
- Written Communication
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Education Experience
- 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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