Quality Management Expansion Analyst

Role Overview

• Support the global deployment of SAP Quality Management capabilities integrated with NextGen QS, enabling real-time quality event handling and non-conformance management across Source, Make, and Deliver.
• Ensure standard satellite system integrations enabling end-to-end release management, laboratory testing, manufacturing batch record review, and artwork (packaging material) key date governance.
• Enable Global Batch Traceability through a single ERP backbone after full deployment and prepare the solution for future GBT and BRH integration.
• Define and govern batch determination rulesets ensuring compliant batch usage for internal operations and customer shipment.
• Work under guidance of Quality Management functional SMEs and analysts, owning workload planning, prioritization, and delivery quality.
• Provide functional leadership and coaching while remaining hands-on to ensure solution quality and regulatory compliance.
• Act as the primary functional escalation point for QM-related topics within Transcend.
• Participate in solution confirmation with Global Template Owners, Quality Assurance, and Regulatory stakeholders.
• Oversee functional testing, validation support, and hypercare activities for QM capabilities in alignment with GxP and CSV expectations.
• Ensure QM issues are resolved and lessons learned are incorporated into continuous improvement of the global template.
• Collaborate with Manufacturing, Supply Chain, Commercial Execution, IT, Validation, and Quality Assurance teams to ensure end-to-end quality integration.
• Partner with system integrators and satellite system owners to ensure compliant, auditable, and sustainable integrations.

Requirements

• University degree or equivalent experience in Quality, Engineering, Life Sciences, or a related discipline.
• A minimum of four years professional experience.
• Extensive experience in Quality Management processes within GxP-regulated manufacturing environments.
• Strong functional expertise in SAP S/4HANA Quality Management (QM), including batch management, inspection processes, non-conformance handling, and release workflows.
• Proven experience leading or supporting SAP implementations subject to Computer System Validation (CSV) and regulatory inspection.
• Demonstrated people-management experience with accountability for functional delivery and quality outcomes.

Tech Stack

• ERP

Benefits

• Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Eligible to participate in the Company’s long-term incentive program.
• Vacation – 120 hours per calendar year.
• Sick time
• 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year.
• Holiday pay, including Floating Holidays – 13 days per calendar year.
• Work, Personal and Family Time
• up to 40 hours per calendar year.
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child.
• Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year.
• Caregiver Leave – 80 hours in a 52-week rolling period.
• Volunteer Leave – 32 hours per calendar year.
• Military Spouse Time-Off – 80 hours per calendar year.