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 Description The Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) sites that manufacture active...
Education : A Bachelors Degree in environmental science, chemistry, biology or a related scientific discipline is required, although a Masters Degree is preferred....
Principal Scientist (Director) - Regulatory Affairs-CMC
- North Wales, PA
- 12 days ago
- North Wales, PA
- 12 days ago
Fields of study include Biology, Microbiology, or Biochemistry, Chemical, Mechanical and Electrical Engineering....
Principal Scientist (Director) - Regulatory Affairs-CMC
- Upper Gwynedd, PA
- 14 days ago
- Upper Gwynedd, PA
- 14 days ago
Fields of study include Biology, Microbiology,or Biochemistry, Chemical, Mechanical and Electrical Engineering....
Director, Regulatory Affairs - Specialty (Infectious Disease, HIV)
- Collegeville, PA
- 30+ days ago
- Collegeville, PA
- 30+ days ago
Capable of organising and executing successful milestone meetings and with track record of successful relationship with one or more Health Authority Extensive knowledge of clinical trial and licensing...
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...
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...
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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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
- Continuous Improvement
- Affirmative Action
- Quality Systems
- Implementation
- Quality Management
- Document Control
- Coaching
- Inspections
- Quality Management Systems
- Batch Record Review
- GxP
- TrackWise
- ICH GCP
- Animal Models
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Neurobiology
- Molecular Biology
- Biology
- Biochemistry
- Drug Development
- Immunology
- Microbiology
- Immunohistochemistry
- Biotechnology
- Clinical Trials
- Laboratory Management
- Equipment Calibration
- Medical Device Sales
- Corrective Actions & Preventive Actions
- FDA Regulations
- Research and Development
- Good Manufacturing Practices
- Process Development
- Standard Operating Procedures
- Engineering
- Strategy Development
- Quality Control
- Auditing
- Investigation
- Written Communication
- Education Experience
- Quality Assurance
- Collaboration
- Documentation
- Reporting
- Bachelor's Degree
- Inventory Management
- Regulations
- Project Management
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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