GxP Program Manager

Description:

Role Summary

The GxP Program Manager is responsible for end-to-end delivery of GPM application, data, and integration initiatives, including sustainability/modularization efforts, technical remediation, production releases, webservices, and data archiving.

Key Responsibilities:

- Planning and execution of projects across the full SDLC in accordance with GxP and SDLC governance requirements.

- Modularization efforts to improve long-term maintainability and speed to market.

- Partner with Quality and Compliance teams to ensure releases meet 21 CFR Part 11 requirements (electronic records, audit trails, access controls).

- Ensure integrations and webservices comply with GxP data integrity, security, and traceability requirements.

- Delivery of GPM initiatives in compliance with GxP regulations, including 21 CFR Part 11, data integrity, validation, and audit-readiness expectations.

- Support regulated environments by embedding quality, validation, and compliance controls across application, data, and integration initiatives.

- Maintain integrated project plans, RAID logs, and milestone tracking.

- data archiving initiatives align with GxP records retention, data integrity, and regulatory requirements.

- Manage cross-team impacts related to data changes, archiving, and system upgrades.

- Lead governance cadence, decision forums, and stakeholder communications.

Required Skills & Experience (Enhanced):

- Experience managing IT projects in GxP-regulated environments (pharma, biotech, life sciences, or regulated manufacturing).

- Working knowledge of 21 CFR Part 11, SDLC controls, validation lifecycle, and audit expectations.

- Strong understanding of data integrity principles (ALCOA+), records retention, and compliant data archiving.

- Experience operating within controlled change management and validation governance frameworks.

- Oracle ERP Knowledge