Position Overview:
The Assistant Director of Quality Assurance will support the overall QA strategy and operations across Medivant's manufacturing sites. This role emphasizes cross-functional quality systems coordination, supplier quality oversight, and continual process improvement. The Assistant Director will work closely with the Director of Quality and lead QA teams in executing day-to-day compliance activities while ensuring adherence to cGMP, FDA, and international regulatory requirements.
Key Responsibilities:
- Oversee and manage Quality Systems including Change Control, CAPA, Deviations, and Document Control across the organization.
- Lead internal audit preparation, execution, and follow-up actions to maintain a state of inspection readiness.
- Coordinate with cross-functional departments to ensure timely resolution of quality events.
- Support regulatory inspections (FDA, DEA, EU, etc.) and contribute to response generation and implementation of corrective actions.
- Ensure batch record review and product release are conducted efficiently and in compliance with regulatory requirements.
- Develop and maintain metrics for QA performance monitoring and continuous improvement.
- Manage supplier quality activities, including qualification, audits, and performance evaluations.
- Provide quality input for new product introductions, technology transfers, and process validations.
- Train and mentor QA staff to build strong technical competencies and ensure adherence to quality processes.
- Collaborate with production and QC teams to identify and mitigate compliance risks.
Qualifications:
- Bachelor’s or master’s degree in pharmacy, Chemistry, Life Sciences, or related field.
- Minimum of 10+ years of progressive QA experience in a pharmaceutical GMP environment, preferably injectables or sterile manufacturing.
- Strong knowledge of FDA, ICH, and cGMP requirements.
- Excellent communication, problem-solving, and leadership skills.
- Experience in dealing with regulatory authorities and audits.
- Proficient in electronic Quality Management Systems (eQMS) and Microsoft Office tools.