Director of Quality Assurance and Regulatory Affairs Jobs in Pennsylvania
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 City : Malvern State : PA Country : US Job Term : Permanent Overview : PharmaLogics Recruiting is seeking an Associate Director, Regulatory Affairs in...
Job title Manager, Regulatory Affairs North America Function Regulatory Affairs Group Sub function Regulatory Affairs Category Manager, Regulatory Affairs (P7) Location Spring House / United...
Job Purpose The Director of Regulatory Affairs will lead regulatory strategy, submission planning, and execution for Ocugens biologics, cell, and gene therapy programs. This role is responsible...
Knowledge of lab safety protocols and regulations. Preferred Skills: Experience with advanced battery technologies (e.g., solid-state, lithium-ion, sodium-ion)....
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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...
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...
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...
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Director of Quality Assurance and Regulatory Affairss in Pennsylvania 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
- Affirmative Action
- Quality Systems
- Implementation
- Change Control
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- ASQ Certified Quality Auditor
- TrackWise
- 21 CFR 820
- Institutional Review Board
- Assay Development
- Good Clinical Practice
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Genotyping
- Lab Safety
- Cell Culture
- Molecular Biology
- Clinical Laboratory Operations
- Polymerase Chain Reaction
- DNA Isolation
- Drug Development
- Western Blot
- Biology
- Medical Writing
- Pharmacovigilance
- Stem Cells
- Microbiology
- Microscopy
- Good Laboratory Practice
- Scientific Writing
- Biotechnology
- Clinical Trials
- Laboratory Management
- FDA Regulations
- Medical Device Sales
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Control
- Military Background
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Education Experience
- Bachelor's Degree
- Reporting
- 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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