Transcend: Deploy Make QM Exp Analyst

Johnson & Johnson Innovative Medicine•Malvern, PA

2d•Hybrid

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. About Transcend Transcend is a global business transformation program that will modernize our foundational transactional processes and harmonize them into one clean ERP as a standardized platform for growth and efficiency gains. The program will simplify the Pharmaceutical ERP landscape from seven systems to one, standardizing processes to create a cost-effective, fit-for-purpose digital backbone that enables agility and scalability across the business. Additionally, Transcend will remediate end-of-life system exposure expected toward the end of this decade, reducing risk while enabling long-term sustainability. Role Purpose The Functional Deployment Lead – Quality Management (QM) provides advanced hands-on expertise supporting 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

A minimum two years professional experience
University degree or equivalent experience in Quality, Engineering, Life Sciences, or a related discipline.
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.
Ability to travel up to 50% of the time both domestically and internationally.

Responsibilities

Execute and 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.
Act as senior functional authority supporting 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.
Support 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

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