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.
