Project Lead

Job Description:

Key Responsibilities

• Lead planning and execution of CPV Stage 3A (Historical Transition Reports) and 3B (Annual Monitoring).
• Coordinate data gathering from internal systems (TRU, ADPR, CEDMS, batch records) and external manufacturing partners.
• Define data workflow: extraction tabulation verification Minitab analysis report compilation routing for client approval.
• Manage Jr and Sr Data Admins, ensuring strict separation between tabulation and verification functions.
• Oversee statistical analysis outputs (Ppk, CPV limits, run charts, trend assessments) and ensure alignment with SOP0002200.
• Ensure all data is tabulated, reviewed, and included in report appendices.
• Identify discrepancies, trends, excursions, or shifts requiring escalation or SME evaluation.
• Interface regularly with client QA, Tech Ops, Mathematical Sciences, and EM site partners.
• Mainta...