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.
Job title : Lab Manager- Bacteriology Assays Location : Swiftwater, PA Summary The Laboratory Manager for bacteriology assays will develop, optimize, qualify, validate, and execute bacteriological...
Job Description The Authorized Person (AP), Associate Director, Clinical Supplies Quality, plays a critical role in the review and certification of batches intended for use in clinical trials. The...
Associate Director, Regulatory Affairs (mRNA vaccines)
- Collegeville, PA
- 7 days ago
- Collegeville, PA
- 7 days ago
Site Name: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Durham Blackwell Street, Rockville Vaccines, Upper Merion, Waltham Posted Date: Mar 5 2025 Are you looking for a highly...
Site Name: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Collegeville TSA, USA - Maryland - Rockville Posted Date: Mar 3 2025 Job Purpose Ensure the development of appropriate...
Lab Manager (Department of Neurology) University of Pennsylvania
- Philadelphia, PA
- 12 days ago
- Philadelphia, PA
- 12 days ago
They will also have molecular biology competence including western blot, qPCR and immunostaining, and cell culture expertise....
They will also have molecular biology competence including western blot, qPCR and immunostaining, and cell culture expertise....
Associate Director Regulatory Affairs (Immune Health Institute) University of Pennsylvania
- Philadelphia, PA
- 14 days ago
- Philadelphia, PA
- 14 days ago
Associate Director Regulatory Affairs (Immune Health Institute) University Overview The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in...
Associate Director Regulatory Affairs (Immune Health Institute)
- Philadelphia, PA
- 14 days ago
- Philadelphia, PA
- 14 days ago
University Overview The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League...
Director of Regulatory Affairs (Newtown, PA) --Manage and direct regulatory affairs and compliance and serve as principal regulatory contact with the U.S. Food and Drug Administration (FDA) on...
Director, Regulatory Affairs (US) Job Requisition ID: 32387 Department: REG Category: Corporate - M&A Location: Philadelphia Date: 9 Feb 2025 Come and Save Lives with Us! SERB Pharmaceuticals is a...
Director Regulatory Affairs Job ID: 7576 Job Title: Director Regulatory Affairs Location: Greater Philadelphia, PA Location: (Hybrid) Greater Philedelphia, PA (or) Boston, MA Position Our client...
Senior Director, Regulatory Affairs, Combination Products
- Plymouth Meeting, PA
- 30+ days ago
- Plymouth Meeting, PA
- 30+ days ago
About INOVIO INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases....
Job title: Lab Manager- Bacteriology Assays Location: Swiftwater, PA Summary The Laboratory Manager for bacteriology assays will develop, optimize, qualify, validate, and execute bacteriological...
Manager, Quality Assurance Operations iPBMCs
- Philadelphia, PA
- 30+ days ago
- Philadelphia, PA
- 30+ days ago
Overview Iovance Biotherapeutics is a growing company focused on the development and commercialization of immunotherapies based on TIL (Tumor Infiltrating Lymphocytes). The Quality Assurance (QA)...
Remote WorkDirector of Quality Assurance - Compliance and Batch Disposition
- Conshohocken, PA
- 45+ days ago
- Conshohocken, PA
- 45+ days ago
About Madrigal: Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH)....
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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
- English
- Quality Systems
- Supplier Management
- Distribution
- Implementation
- Resolution
- Safe Quality Food
- Coaching
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- Food Manufacturing
- 21 CFR 820
- Assay Development
- Real-Time Polymerase Chain Reaction
- Gene Therapy
- ICH Guidelines
- Genotyping
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Drug Discovery
- Pharmacovigilance
- Clinical Laboratory Operations
- DNA Isolation
- Drug Development
- Medical Writing
- Microbiology
- Biology
- Immunology
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Clinical Trials
- Biotechnology
- Laboratory Management
- FDA Regulations
- Medical Device Sales
- Good Manufacturing Practices
- Corrective Actions & Preventive Actions
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Military Background
- Troubleshooting
- Quality Control
- Investigation
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Inventory Management
- Regulations
- Teaching
- Policy Development
- Project Management
- Research Skills
- Microsoft Office
- Problem Solving
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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