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.

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.
Preferred: Experience integrating SAP QM with Quality satellite systems such as NextGen QS, LIMS, or electronic batch record platforms.
Preferred: Experience with Global Batch Traceability (GBT) and/or Batch Record Hub (BRH) concepts or implementations.
Preferred: Prior involvement in global ERP transformations within the Pharmaceutical or Life Sciences industry.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

SAP S/4HANA Quality Managementbatch managementinspection processesnon-conformance handlingrelease workflowsComputer System Validationregulatory inspectionGlobal Batch TraceabilityBatch Record Hubquality management processes

Soft Skills

functional leadershipcoachingworkload planningprioritizationdelivery qualitypeople managementaccountabilitycollaboration