Sr. Specialist, Quality IT

Required

• Bachelor’s degree in Science, Information Technology, Engineering, or an equivalent technical discipline.
• An advanced degree or relevant professional certification is preferred.
• A minimum of 7 years of relevant experience in the pharmaceutical, biotechnology, or medical-device industry, including at least 4 years supporting Quality Assurance, computerized system validation/assurance, IT Quality, or regulated computerized-system lifecycle activities.
• Working knowledge of global GxP requirements and expectations for computerized systems, including FDA 21 CFR Part 11, EU Annex 11, data integrity, and GAMP 5.
• Experience reviewing or authoring validation and lifecycle deliverables such as risk assessments, requirements, test protocols, traceability matrices, validation reports, change controls, deviations, and CAPAs.
• Experience with one or more enterprise or regulated platforms, such as QMS, document management, validation management, change control, LIMS, Veeva, ERP, or SAP.
• Ability to apply risk-based CSV/CSA principles and translate compliance requirements into practical actions.
• Strong technical writing, documentation-review, analytical, and problem-solving skills.
• Ability to communicate clearly and collaborate effectively with internal stakeholders and external suppliers.
• Ability to prioritize and manage multiple concurrent assignments while maintaining documentation quality and meeting commitments.
• Highly motivated, adaptable, organized, detail-oriented, and capable of working with limited day-to-day supervision.
• Experience supporting audits or regulatory inspections is preferred.