
Director of Pharmaceutical Quality
5 days ago
We are seeking an exceptional Quality Leadership professional to oversee and direct all QA and QC activities, ensuring pharmaceutical products meet stringent regulatory standards.
This strategic leadership role is responsible for leading quality management systems, overseeing quality system documentation, and conducting internal and supplier audits. The successful candidate will lead all QA programs, including batch record review, final product release, CAPA, deviations, and risk management.
Key responsibilities include:
- Establishing, implementing, and maintaining robust quality management systems aligned with cGMP, GLP, ICH guidelines, and other applicable standards.
- Serving as lead company representative during regulatory and certification audits/inspections.
- Overseeing quality system documentation, including SOPs, protocols, batch records, validation, and change control.
- Leading all QA programs, including batch record review, final product release, CAPA, deviations, and risk management.
Requirements:
- Bachelor's or Master's in Pharmacy, Chemistry, Life Sciences, or related field.
- Minimum 10 years in pharmaceutical QA/QC, including 5+ in senior leadership.
- Extensive knowledge of cGMP, GLP, GCP, ICH Q7/Q8/Q9/Q10, and international regulatory requirements.
- History of successful regulatory inspections, audit leadership, and operational excellence.
The ideal candidate will possess:
- Expert understanding of pharmaceutical regulations, QMS, and data integrity.
- Strong leadership, organizational, team development, and communication skills.
- Analytical, decisive, and solution-oriented with attention to detail.
- Skilled in process improvement, problem-solving, risk management, and change control.
This is a greenfield opportunity to join a pharmaceutical startup and drive quality excellence from the ground up.
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