Job Description

Job Responsibilities:

• Oversees day-to-day activities of Quality Assurance teams supporting manufacturing and processing operations.
• Establishes and tracks key performance indicators (KPIs) related to batch record review, "Right First Time" metrics, and timelines for batch release.
• Manages staffing, professional development, and budgeting for QA team members.
• Leads investigations into product quality issues and manufacturing deviations, ensuring thorough documentation and resolution.
• Reviews root cause analyses and implements effective corrective and preventive actions (CAPAs), along with monitoring effectiveness.
• Reviews and approves quality documentation, including investigations, CAPAs, standard operating procedures (SOPs), change controls, and validation protocols and reports.
• Ensures documentation is accurate, complete, and meets compliance requirements; coordinates the compilation and approval of Annual Product Reviews and related performance metrics.
• Acts as a key QA representative during regulatory inspections and audits, facilitating prompt access to required documentation and information.
• Organizes internal audits and readiness assessments, and monitors implementation of corrective actions as needed.

Qualifications:

• Bachelor’s degree required (Chemistry, Biology, or science related).
• Minimum 4 years of in experience in Quality Assurance/Quality Control within the pharmaceutical industry
• Minimum of 3 years in a managerial or leadership role.
• Experience with sterile injectables and radiopharmaceuticals is highly desirable.

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