Director of Quality Assurance

4 weeks ago


Exton, Pennsylvania, United States Frontage Laboratories Full time
Job Summary:

The Director of Quality Assurance, Pharmaceutical Manufacturing plays a critical role in the development, maintenance, and continuous improvement of quality management systems to uphold quality standards and compliance. This position ensures seamless integration with global quality processes.

Responsibilities:
  • Manage the quality assurance department to support the GLP and GMP manufacturing of drug dosage forms for preclinical and clinical trial studies, and commercial production.
  • Host regulatory agent inspections such as FDA, EU QP, and DEA, and provide responses to ensure quality compliance.
  • Develop and approve quality agreements with clients, host client audits, and provide responses, and ensure action items are completed to meet the requirements.
  • Develop, implement, and oversee quality systems at Frontage manufacturing facilities to ensure product reliability, quality, efficacy, and alignment with global standards.
  • Manage supplier qualification, including quality agreements and audit reports.
  • Provide staff annual GMP training with expertise and guidance in interpreting and implementing government and agency guidelines to ensure current GMP compliance.
  • Maintain and continuously improve the use of electronic quality management systems.

Requirements:
  • BS or advanced degree in a scientific discipline or related area.
  • 10-15 years of experience in pharmaceutical/biotech industry, including manufacturing, development, and quality.
  • 6-8 years of experience in quality management and leadership positions.
  • 5 years of experience in quality for late phase clinical trial material and commercial drug manufacturing of various formats.
  • Demonstrated knowledge of US, EMA, and ICH regulations, guidance, and industry standards for CGMP (21 CFR Part 210, 211).
  • Experience in hosting regulatory authorities' inspections and providing responses.
  • Strong working knowledge of pharmaceutical quality systems (deviations, CAPA, GMP change controls).
  • Experience leading deviation and non-conforming material investigations.
  • Excellent written, oral, and interpersonal communication skills.
  • Ability to think and act strategically.
  • Self-directed, multi-tasker, and ability to work effectively with cross-functional teams.
  • Proven technical writing/editing skills and problem-solving ability.
  • Strong attention to detail, excellent organization skills, and cultural fit.
  • Proficiency in Microsoft Office applications.
  • Ability to operate in a fast-paced, multi-disciplinary virtual environment.


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