Director of Quality Assurance
4 weeks ago
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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