Transcend GTO-QM, Clinical Quality
Listed on 2026-08-01
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Quality Assurance - QA/QC
Regulatory Compliance Specialist
IM Transcend:
Global Template Owner – Quality Management – Clinical/R&D Quality
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 Med Tech, 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.
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.
This hybrid position will be located in Titusville, New Jersey. Alternate hybrid locations may be considered in Raritan, New Jersey;
Malvern, Pennsylvania;
Springhouse, Pennsylvania;
Toronto, Canada;
Latina, Italy;
Cork, Ireland;
Beerse, Belgium;
Leiden, Netherlands; or Zug or Shaffhausen, Switzerland.
Are you ready to be part of a multi-year global business transformation initiative that will transform and standardize our core business processes and products across Plan, Source, Make, Quality, Deliver, and Data, and enable our integrated data strategy through a single SAP S/4 HANA instance? Apply today for this exciting opportunity to shape and set the future direction for supporting and improving our new process across all areas.
As a member of the Quality Management team, this role will lead the consolidation of Clinical/R&D Quality business processes and support the creation of the Global Template aligned with the Transcend Global roadmap rollout.
Key Responsibilities:- Serve as the Innovative Medicine subject matter expert for all Clinical/R&D Quality activities to drive global S/4 HANA capability standardization, alignment, and adoption.
- Ensure all Clinical/R&D Quality processes and designs align with the Transcend future‑state blueprint.
- Act as a Change Champion across Clinical/R&D Quality to support global standardization and process harmonization.
- Develop, document, and steward the Global Template, ensuring integrity, consistency, and alignment across all markets.
- Apply strong global and business-focused reasoning in handling critical issues, business risks, and the development of mitigation strategies.
- Build and optimize business processes aligned with the future-state Clinical/R&D Quality ecosystem architecture and support adoption across regional organizations.
- Support the execution of Business Simulation and User Acceptance Testing, as needed, ensuring deployment team understanding of intended template designs.
- Document and map all end‑to‑end Clinical/R&D Quality processes, ensuring high-quality and up‑to‑date knowledge center content.
- Provide insights and support for training design, compliance documentation, and ongoing process updates.
- Develop and implement standard testing approaches and tools to ensure consistent process validation.
- Support quality compliance, system validation, and change control processes to maintain an ongoing compliant state and ensure operational excellence.
EDUCATION:
- Minimum of High School or equivalent diploma/degree is required;
Bachelor's / University or equivalent degree strongly preferred - Certifications are helpful in one or more of the following: PMP, FPX, or equivalent project management; APICS; and/or Lean/Six Sigma /Process Excellence
Experience and skills:
- Minimum 10 years of relevant work experience
- Business functional experience (i.e., Operations, Supply Chain, and/or Finance) working in a complex, multi-ERP / system environment
- Experience in operating or supporting large-scale ERP processes following transformation/implementation programs
- Experience in supporting, improving, developing, implementing, and leading operational technological processes within a global organization
- Strong interpersonal, relationship building, and negotiating/influencing skills, with demonstrated ability…
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