Manager, Global Quality Tech Ops-Digital Transformation & Innovation
About The Position
PCI Pharma Services is hiring a Manager, Global Quality Tech Ops-Digital Transformation & Innovation to support digital transformation and innovation across global quality operations. The role serves as a global technical lead for MasterControl configuration enhancements, standardization, deployment of new modules, and integrations with PCI’s Enterprise Resource Planning system and other potential systems. It also designs and maintains automated quality metrics dashboards, supports validation and compliance, converts traditional paper-based or hybrid workflows into digital workflows, and establishes data integrity governance across digital platforms. The position requires adherence to PCI, cGMP, and GCP policies and procedures. The posting says extra hours and/or weekend work may be required. Attendance is an essential function. Supervisory responsibilities are described in general terms, but the posting specifically states: “No Supervisory Responsibilities.” Work is primarily performed at a desk and/or in a quiet office environment. The role is described as requiring stationary work for three-quarters of the day or more, communication and detection tasks for one-quarter to one-half of the day, and moving or transporting up to 10 pounds for less than one-quarter of the day. The employee must be able to focus visually.
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 for professional needs.
- Highest reasoning ability, including applying logical or scientific principles to complex intellectual and practical problems and working with concrete and abstract variables.
- Ability to work independently and/or as part of a team.
- May be required to work extra hours and/or weekends.
- Ability to meet the stated physical demands, with or without reasonable accommodation, including stationary work for three-quarters of the day or more, communication and detection tasks for one-quarter to one-half of the day, transporting up to 10 pounds for less than one-quarter of the day, and visual focusing.
Nice To Haves
- 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 and ability 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.
- Translate 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/Supervisor.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
