Manager, Global Quality Tech Ops-Digital Transformation & Innovation

PCI Pharma Services • Philadelphia, PA

24d

About The Position

PCI Pharma Services is seeking a Manager, Global Quality Tech Ops-Digital Transformation & Innovation to lead global technical improvements and digital transformation of quality systems. The role focuses on MasterControl configuration, module deployment, system integrations, automated quality metrics, validation and compliance, digitized workflows, and data integrity governance. The position requires adherence to PCI, cGMP, and GCP policies and procedures. It may require extra hours and/or weekend work. Attendance is an essential function of the position. The role also performs other duties as assigned by a Manager or Supervisor. The posting states that there are no supervisory responsibilities.

Requirements

• Bachelor’s degree in a related field and/or 5–7 years of related experience and/or training.
• College-level mathematical skills.
• Advanced computer skills, including the ability to perform complex computer tasks and operate various computer programs.
• Full professional proficiency in speaking, reading, and writing fluently and accurately for professional needs.
• Ability to apply logical or scientific reasoning to a wide range of intellectual and practical problems and work with concrete and abstract variables.

Nice To Haves

• Ability to work independently and/or as part of a team.
• Strong proficiency in data visualization tools such as PowerBI or Tableau, or SQL.
• Experience managing data migration activities from legacy systems to cloud-based QMS platforms.
• Excellent communication skills to translate complex technical requirements to non-technical quality stakeholders.

Responsibilities

• Serve as a global technical lead for MasterControl configuration enhancements, standardization of ways of working, deployment of new modules, and integrations with PCI’s Enterprise Resource Planning system and other potential systems.
• Design, build, and maintain automated quality metrics dashboards, such as through PowerBI or MasterControl Insights, to track KPIs, CAPA trends, and training compliance.
• Collaborate on validation life cycle documentation, including URS, FRS, IQ/OQ/PQ, following GAMP 5 methodologies, FDA 21 CFR Part 11, and Annex 11.
• Convert paper-based or hybrid quality workflows into streamlined, automated digital workflows within MasterControl.
• Establish and enforce data integrity governance across digital platforms to meet FDA, EMA, and MHRA expectations.
• Adhere to PCI, cGMP, and GCP policies, procedures, and rules.
• Perform other duties as assigned by the Manager or Supervisor.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager