Director of Quality Assurance and Regulatory Affairs Jobs in King Of Prussia, PA
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.
Senior Manager, Regulatory Affairs
- Philadelphia, PA (15 miles from King Of Prussia, PA)
- 19 days ago
- Philadelphia, PA (15 miles from King Of Prussia, PA)
- 19 days ago
Senior Manager, Regulatory Affairs Jazz Pharmaceuticals $134,400.00 - $201,600.00 vision insurance, 401(k) United States, Pennsylvania, Philadelphia Jul 29, 2025 If you are a current Jazz employee...
Senior Director, Regulatory Affairs
- Philadelphia, PA (15 miles from King Of Prussia, PA)
- 19 days ago
- Philadelphia, PA (15 miles from King Of Prussia, PA)
- 19 days ago
This position is responsible for building the regulatory team at Context Therapeutics. The Senior Director of Regulatory Affairs will define and implement innovative regulatory strategies that...
Associate Director, Regulatory Affairs CMC
- Radnor, PA (2 miles from King Of Prussia, PA)
- 27 days ago
- Radnor, PA (2 miles from King Of Prussia, PA)
- 27 days ago
May require technical regulatory authoring to support responses to queries Maintains up to date knowledge and expertise with FDA/EMA regulations, ICH guidelines and other international regulatory regulations...
I s Kymanox the right fit for you? You want to make a difference and have an impact You enjoy having an influence in your day-to-day work You are motivated by working alongside a team filled with...
Demographic Data for King Of Prussia, PA
Moving to King Of Prussia, PA? Find some basic demographic data about King Of Prussia, PA below.
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Director of Quality Assurance and Regulatory Affairss in King Of Prussia, PA 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
- Molecular Biology
- ICH Guidelines
- Medical Affairs
- Next-Generation Sequencing
- Clinical Laboratory Operations
- Water Testing
- Biology
- Scientific Research
- Microbiology
- Drug Development
- Pharmacovigilance
- 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
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