Transcend GTO-QM, Clinical Quality

Regulatory Jobs; Titusville (NJ); On-site; USD 122,000 - 213,000; Full time

Benefits offered by this job

Long-term incentive program

401(k) plan

Paid time off

Job summary

Johnson & Johnson is seeking a Global Template Owner for Quality Management – Clinical/R&D, based in Titusville, NJ with hybrid work options. Lead the consolidation of Quality processes and create a Global Template aligned with the Transcend roadmap.

Requires 10+ years in relevant roles, SAP/ERP experience, and ability to operate across global markets across multiple countries. The role emphasizes standardization, training support, and change management within a large-scale ERP transformation to

Qualifications

• 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
• Minimum 10 years of relevant work experience
• Business functional experience in Operations, Supply Chain, and/or Finance
• Experience with large-scale ERP processes following transformation/implementation programs
• Experience leading operational technological processes within a global organization
• Proven experience with SAP ERP replacement projects
• Willingness to travel up to 30%
• Must be on-site at least three days per week with two remote workdays

Responsibilities

• Serve as the Innovative Medicine SME for Clinical/R&D Quality to drive global S/4 HANA capability standardization, alignment, and adoption
• Ensure all Clinical/R&D Quality processes align with the Transcend blueprint
• Act as a Change Champion to support global standardization and harmonization
• Develop, document, and steward the Global Template with market alignment
• Provide insights for training design, compliance documentation, and ongoing process updates
• Document and map end-to-end Clinical/R&D Quality processes for the knowledge center

Skills

10+ years experience

ERP experience

Cross-functional collaboration

People management

Stakeholder management

Education

High School diploma or equivalent

Bachelor’s degree preferred

PMP / FPX / APICS

Lean/Six Sigma

Tools

SAP ERP

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: Quality

Job Sub Function: Digital Quality

Job Category: People Leader

All Job Posting Locations: Malvern, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

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.

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.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United States - Requisition Number: R-089314

Switzerland - Requisition Number: R-090763

Canada- Requisition Number: R-090760

Belgium, Ireland, Netherlands, and Italy - Requisition Number: R-090765

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

We are searching for the best talent for an IM Transcend: Global Template Owner – Quality Management – Clinical/R&D Quality! 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?

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.

Qualifications:

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:

Required:

• 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 to collaborate and communicate at various levels including program teams / execution and senior leadership / strategic levels
• People management and development experience (direct or indirect reports and internal/external partners)

Preferred:

• Pharmaceuticals, Life Sciences, or other regulated industry experience
• Experience with business process design, engineering, or optimization
• Proven experience with large-scale SAP ERP replacement project(s)
• Experience effectively leading and governing multi-functional decision-making bodies
• Experience in deploying and/or improving standardized work processes, tools, and templates

Other:

• Requires proficiency in English (written and verbal) to communicate effectively and professionally; proficiency in German, Dutch, or Italian is helpful
• May require up to 30% domestic and international travel depending on work location and business needs
• Requires the ability, through our flexible work policy, to work on-site a minimum of three days each week, with the option for two remote workdays each week

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Compliance Management, Controls Compliance, Developing Others, Digital Assurance, Digital Governance, Human-Computer Relationships, Inclusive Leadership, Leadership, Performance Measurement, Process Optimization, Program Management, Quality Control (QC), Quality Standards, Quality Validation, Regulatory Compliance, Stakeholder Engagement, Standard Operating Procedure (SOP), Strategic Change, Team Management

The anticipated base pay range for this position is :

$122,000.00 - $212,750.00

Additional Description for Pay Transparency:

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.

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

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits