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.
The Grace Lab in the University of Pittsburgh, School of Medicine Department of Microbiology and Molecular Genetics is seeking an experienced Lab Manager. The lab uses human in vitro and mouse in...
The Gene Therapy Program (GTP) is entering a new era of unprecedented opportunity with the great potential to reshape the face of medicine as we know it. Our discoveries have set the stage for...
Qualifications : Bachelor's degree in Biology, Chemistry, medical technology or related field with 5-7 years of experience working in a relevant lab or manufacturing setting required....
Director, Regulatory Affairs - Specialty (Infectious Disease, HIV)
- Collegeville, PA
- 20 days ago
- Collegeville, PA
- 20 days ago
Site Name: Durham Blackwell Street, USA - Pennsylvania - Upper Providence Posted Date: Jun 10 2025 Job Purpose Ensure the development of appropriate regional regulatory strategy(s) and their...
Location: REMOTE Salary: $190,000.00 USD Annually - $215,000.00 USD Annually Description: Our client is currently seeking a Director, Regulatory Affairs Strategy who will be responsible for...
Local telecommuting permitted up to 2 days per week. 5% domestic travel and 5% international travel required.Minimum Requirements: Bachelor's degree in Drug Regulatory Affairs, Pharmacy, Biology, Chemistry...
Your experience and qualifications Bachelor's degree in Drug Regulatory Affairs, Pharmacy, Biology, Chemistry, or a related field and 2 years of experience in the biotech/pharmaceutical industry in...
Modern Industries, Inc.** is seeking a highly qualified and experienced **Environmental Laboratory Director** to lead our State/National certified environmental testing laboratories. This is a...
Interius BioTherapeutics Is Seeking a Lab Manager to join us on our incredible journey Can you see yourself as part of a growing team working to develop targeted vectors to reprogram cells in vivo...
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...
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Highest Education Level
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
- Quality Systems
- Implementation
- Quality Management
- Change Control
- Coaching
- Inspections
- Quality Management Systems
- Batch Record Review
- Internal Audits
- GxP
- ASQ Certified Quality Auditor
- TrackWise
- Institutional Review Board
- ICH GCP
- Assay Development
- Animal Models
- Gene Therapy
- ICH Guidelines
- Neurobiology
- Lab Safety
- Molecular Biology
- Genotyping
- Next-Generation Sequencing
- Cell Culture
- Polymerase Chain Reaction
- Drug Development
- Biochemistry
- Biology
- Immunology
- Medical Writing
- Microbiology
- Scientific Writing
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Laboratory Management
- Equipment Calibration
- Good Manufacturing Practices
- FDA Regulations
- Research and Development
- Standard Operating Procedures
- Masters In Education
- Engineering
- Strategy Development
- Quality Control
- Investigation
- Auditing
- Written Communication
- Collaboration
- Documentation
- Quality Assurance
- Reporting
- Interpersonal Skills
- Bachelor's Degree
- Education Experience
- Regulations
- Inventory Management
- Policy Development
- Microsoft Office
- Problem Solving
- Research Skills
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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