Senior Director, eCompliance – Global Quality Technical Operations

PCI Pharma Services

Sr. Director, eCompliance leading digital validation and data integrity strategies at PCI Pharma Services.

Posted 5/24/2026full-timePhiladelphia • Pennsylvania • 🇺🇸 United StatesSeniorWebsite

Tech Stack

Tools & technologies

CloudSDLC

About the role

Key responsibilities & impact

Define and maintain the Global Computerized System Validation (CSV) Master Plan
Establish standardized Software Development Life Cycle (SDLC) requirements for all GxP systems
Partner with Global IT to ensure that cloud-based platforms and underlying IT infrastructure are qualified and maintained
Serve as the corporate custodian for Data Integrity
Develop and implement standardized protocols for the periodic review of system audit trails
Lead comprehensive data mapping exercises across global sites
Provide technical compliance oversight for the enterprise-wide rollout of MasterControl QMS and eBatch Record
Establish the compliance framework for AI-assisted batch release
Collaborate with MS&T and Engineering to validate the integration of shop-floor systems
Lead organizational change efforts to embed 'Compliance by Design' into the company culture
Act as the primary Quality liaison to Global IT for the deployment of new technologies
Provide 'boots-on-the-ground' assistance to site leadership during complex system deployments
Serve as the lead Subject Matter Expert for eCompliance and Data Integrity during regulatory inspections
Develop and monitor Key Performance Indicators (KPIs) related to system health, validation status, and data integrity compliance
Monitor the evolving international regulatory landscape to ensure PCI Pharma remains at the forefront of global eCompliance trends.

Requirements

What you’ll need

Bachelor’s degree in Information Technology, Computer Science, Quality Assurance, or a related scientific/technical discipline
Minimum of 10 years of progressive experience in an IT Quality, eCompliance, or Computer Systems Validation role within a GxP environment
Proven experience managing large-scale organizational change and digital system implementations
Deep technical expertise in GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, and GDPR
Exceptional ability to influence cross-functional stakeholders and translate complex technical requirements into actionable compliance strategies
Strong communication skills are essential for interfacing with both technical teams and regulatory inspectors.
Highest Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems and deal with nonverbal symbolism in its most difficult phases while dealing with concrete/abstract variables.

Benefits

Comp & perks

Health insurance
401(k) matching
Flexible work hours
Paid time off
Professional development opportunities

ATS Keywords

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Hard Skills & Tools

Computerized System Validation (CSV)Software Development Life Cycle (SDLC)Data IntegrityMasterControl QMSeBatch RecordAI-assisted batch releaseGAMP 5FDA 21 CFR Part 11EU GMP Annex 11GDPR

Soft Skills

influencing stakeholderscommunicationorganizational change managementproblem-solvingcollaboration