Transcend: Deploy Make QM Exp Analyst
About The Position
The Functional Deployment Lead – Quality Management (QM) supports the global deployment of Quality Management capabilities within the Transcend SAP S/4HANA program. From a Quality Management perspective, the role ensures full integration with NextGen QS to enable real-time control and disposition of non-conforming materials and batches across Source, Make, and Deliver. The role owns the end-to-end implementation of Quality processes supporting end-to-end release management, laboratory testing, manufacturing batch record review, and artwork (packaging material) key date management. Global Batch Traceability is enabled through a single ERP backbone after full deployment, with the solution designed to support future integration of Global Batch Traceability (GBT) and Batch Record Hub (BRH). The role also owns the definition and deployment of batch determination rulesets, ensuring that only compliant and appropriate batches are used internally and released for shipment to customers across Make and Deliver.
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.
Nice To Haves
- Experience integrating SAP QM with Quality satellite systems such as NextGen QS, LIMS, or electronic batch record platforms.
- Experience with Global Batch Traceability (GBT) and/or Batch Record Hub (BRH) concepts or implementations.
- Prior involvement in global ERP transformations within the Pharmaceutical or Life Sciences industry.
Responsibilities
- 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.
Benefits
- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Long-term incentive program
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year (may vary by state)
- 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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
