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 SOP‑ .
• 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.
• Maintain timeline consistency across a 12‑month CPV cycle for all products.
• Validate that all team members have completed compliance, system access, and training requirements (including TRU, ComplianceWire, etc.).
• Provide status reporting, risk identification, mitigation, and stakeholder communication.
• Ensure resource planning, quality tracking, and equipment/software provisioning.

Required Skills & Experience

• 5–8+ years in pharma/OTC manufacturing, quality, validation, or process engineering.
• Strong understanding of CPV, PPQ, CQA determination, and statistical process control.
• Experience with EM networks and data‑limited environments (PDF batch records, manual data mining).
• Expert in Minitab, statistics, SPC, and capability analysis.
• Strong technical writing and QC/QA documentation management.
• Comfortable working with global teams and navigating approvals in TRU or similar systems.