Transcend Deploy Experienced Process Analyst-MAKE Quality Management (QM)

Johnson & Johnson Innovative Medicine

Ringaskiddy

Hybrid

EUR 52,000 - 83,000

Full time

4 hours ago

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Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson Innovative Medicine seeks a Deploy Experienced Process Analyst for Make Quality Management (QM) to lead global SAP QM deployment and ensure real-time quality control across manufacturing. The role will drive compliance, batch traceability, and end-to-end QM activities within the Transcend program.

Hybrid position located in Cork, Ireland with potential remote/alternate locations considered; expects strong leadership, regulatory expertise, and collaboration across Manufacturing,

Qualifications

Minimum 4 years of proven experience.
Extensive experience in Quality Management processes within GxP-regulated manufacturing environments.
Strong functional expertise in SAP S/4HANA Quality Management (QM).
Experience leading or supporting SAP implementations subject to Computer System Validation (CSV).
Proven people-management experience with accountability for functional delivery and quality outcomes.

Responsibilities

Execute and support the global deployment of SAP Quality Management capabilities coordinated with NextGen QS, enabling real-time quality event handling and non-conformance management across Source, Make, and Deliver.
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.
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.

Skills

Quality Management

GxP

CSV

Project Leadership

Cross-functional collaboration

Regulatory compliance

Education

University degree in Quality, Engineering, Life Sciences

Tools

SAP S/4HANA QM

NextGen QS

LIMS

Batch Record Hub (BRH)

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

Job Function

Technology Product & Platform Management

Job Sub Function

Technical Product Management

Job Category

Scientific/Technology

All Job Posting Locations

Latina, Italy, Leiden, Netherlands, Leiden, South Holland, Netherlands, Madrid, Spain, Ringaskiddy, Cork, Ireland

Job Description

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. Learn more at https://www.jnj.com/innovative-medicine.

We are searching for the best talent for Transcend Deploy Experienced Process Analyst- MAKE Quality Management (QM).

This hybrid position would be located in Cork, Ireland. Alternate locations may be considered at other Innovate Medicine supply chain locations such as: Latina, Ireland; Madrid, Spain; and Leiden Netherlands. Remote work options may be considered on a case-by-case basis and if approved by the Company.

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.

This program will simplify the Pharmaceutical ERP landscape from 7 to 1, standardizing processes to have a cost-effective, fit-for-purpose digital backbone that will enable us to support the Pharmaceutical business with agility.

Additionally, the program will remediate the end-of-life system exposure that we risk towards the end of this decade.

The Deploy Experienced Analyst – Make 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 leads 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 leads 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.

Key Responsibilities

Global Functional Ownership & Deployment

Execute and support the global deployment of SAP Quality Management capabilities coordinated 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.

Leadership & Team Management

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.

Solution Delivery, Testing & Hypercare

Support solution confirmation with Global Template Owners, Quality Assurance, and Regulatory collaborators.
Supervise 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.

Cross-Functional Collaboration

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.

Qualifications

Education:

University degree or equivalent experience in Quality, Engineering, Life Sciences, or a related field.

Required

A minimum 4 years of proven 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.
Confirmed experience leading or supporting SAP implementations subject to Computer System Validation (CSV) and regulatory inspection.
Proven 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.
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.

Other

Ability to travel up to 50% of the time both domestically and internationally.

Preferred Skills:

Analytical Reasoning, Coaching, Communication, Cross-Functional Collaboration, Demand Forecasting, Human-Computer Interaction (HCI), Persistence and Tenacity, Product Costing, Product Development, Product Strategies, Quality Assurance (QA), Research and Development, Researching, Software Development Management, Technical Credibility, Technologically Savvy

The anticipated pay range for this position, in the primary posting location, is:

€52,400.00 - €82,915.00

The anticipated pay ranges for additional locations are:

Spain – The anticipated base pay range for this position is EUR43,600 – EUR70,150

Italy – The anticipated base pay range for this position is EUR39,800 – EUR64,055

Netherlands – The anticipated base pay range for this position is EUR53,500 – EUR85,445

Benefits

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.