Job Title

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‑0002200. - 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.