Senior Specialist QA – SAP Transcend Lead

We are searching for the best talent for a Senior Specialist QA – SAP Transcend Lead.

Purpose

We are looking for a Senior Specialist QA – SAP Transcend Lead to join Johnson & Johnson Innovative Medicine.

Are you passionate about quality, compliance, and digital transformation? In this role, you will help shape the future of digital quality by supporting the global Transcend program, built on SAP S/4HANA and standardized end-to-end business processes.

As the Senior Specialist QA – SAP Transcend Lead, you will serve as the primary Quality representative for SAP-related initiatives and help ensure that quality, compliance, data integrity, and patient safety are embedded throughout the design, implementation, deployment, and sustainment of digital solutions. This position combines Quality Assurance expertise with knowledge of ERP systems, digital quality processes, and multi-functional business operations within a GMP-regulated environment.

You will be responsible for

In this role, you will represent Quality within local and global Transcend deployment teams and support the successful implementation and governance of SAP S/4HANA-enabled business processes.

Working closely with Business Technology, Operations, Supply Chain, Engineering, Quality Control, and Global Transcend teams, you will help ensure regulatory requirements are translated into practical, compliant, and sustainable digital solutions.

Key responsibilities include:

• Leading Quality activities for the Transcend program and representing Quality Assurance within local and global deployment teams
• Supporting the translation of GMP, Data Integrity, and regulatory requirements into compliant SAP-enabled business processes
• Providing Quality oversight for ERP-enabled processes, including material management, batch management, warehouse operations, master data governance, quality management workflows, and electronic approvals
• Leading Quality review and approval activities related to SAP changes, validation deliverables, risk assessments, testing strategies, and deployment readiness activities
• Partnering with Business Technology, Operations, Supply Chain, Engineering, Quality Control, and Global Transcend teams to support implementation and adoption activities
• Supporting computerized system validation activities and helping maintain inspection readiness of digital systems
• Finding opportunities to simplify, standardize, and automate quality processes through digital solutions
• Assessing compliance risks and providing quality guidance for decisions that may impact compliance, product quality, data integrity, and patient safety
• Supporting continuous improvement initiatives related to digital quality capabilities and business processes

Requirements

We are looking for someone who combines strong quality expertise with an interest in digital technologies and business transformation.

Required Qualifications

• Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, Engineering, Computer Science, or a related field
• Experience working within a GMP-regulated pharmaceutical, biotechnology, or healthcare environment
• Knowledge of Quality Systems, GMP regulations, Data Integrity principles, and risk management practices
• Experience working with SAP ERP systems and digital business processes
• Experience supporting computerized system validation activities and system lifecycle management
• Good communication, collaboration, and stakeholder engagement skills
• Ability to work effectively across functions and in a complex global environment
• Fluent in English, both written and spoken

Preferred Qualifications

• Experience with SAP S/4HANA and modules such as SAP QM, MDG, eWM, or GRC
• Experience supporting ERP implementation programs or digital transformation initiatives
• Knowledge of MES, PAS-X, LIMS, and integrated manufacturing systems
• Experience leading complex multi-functional projects in a global environment
• Knowledge of CSV, GAMP5, and digital quality systems
• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity

Preferred Skills:

Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards

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