Manager, Global Quality Tech Ops-Digital Transformation & Innovation

Essential Duties and Responsibilities

• System Maintenance: Serve as a global technical lead for MasterControl configuration enhancements to standardize ways of working, deployment of new modules, and system integrations with PCI’s Enterprise Resource Planning system and other potential systems.
• Metrics & Analytics: Design, build, and maintain automated quality metrics dashboards (e.g., via PowerBI or MasterControl Insights) to track KPIs, CAPA trends, and training compliance.
• Validation & Compliance: Collaborate on validation life cycle documentation (URS, FRS, IQ/OQ/PQ) adhering to GAMP 5 methodologies, FDA 21 CFR Part 11, and Annex 11.
• Process Digitalization: Translate traditional paper-based or hybrid quality workflows into streamlined, automated digital workflows within MasterControl.
• Data Integrity: Establish and enforce data integrity governance across digital platforms to satisfy FDA, EMA, and MHRA expectations.
• This position may require extra hours and/or weekend work.
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
• Attendance to work is an essential function of this position
• Performs other duties as assigned by Manager/Supervisor.

Supervisory Responsibilities

Carries out supervisory responsibilities in accordance with the organizations policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

• No Supervisory Responsibilities

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required

• Bachelor's Degree in a related field and/or 5-7 years related experience and/or training.
• College Level Mathematical Skills
• Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• 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.

Preferred

• Ability to work independently and/or as part of a team.
• Strong proficiency in data visualization tools (PowerBI, 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.