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.
Maintain timeline consistency across a 12month 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

58+ 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 datalimited 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.

Project Lead