ITCI Change Control Facilitator

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

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.

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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 are searching for the best talent for a ITCI Change Control Facilitator to join our team.

Summary:

The Digital Operations and Technical Services DOTS External Supply Services team manages the pharmaceutical external manufacturing network collaborating closely with Partnerships & External Supply External Quality Technical Operations Planning and Procurement to ensure reliable product delivery and customer service. The DOTS External Supply Services team is the supply chain node that supports internal processes for External Suppliers and ensures compliance for Change Control Serialization and Training.

The ITCI Change Control Facilitator acts as the direct responsible individual (DRI) to actively develop and manage relationships with process users business owners J&J affiliates and external organizations to ensure harmonized and consistent change control processes and to provide guidance/direction regarding execution related to the ITCI portfolio. This role will support the development effective implementation and continued maintenance of Change Controls to ensure compliance is achieved and standards are met.

Key Responsibilities:

• Execution of External Supply change control processes in conformance to current standards and procedures for ITCI suppliers and external manufacturers using applicable system application tools.

• Ensure integrity consistency and compliance of processes for all J&J Innovative Medicine.

• Assure successful implementation of changes and actions by following up and synchronizing activities for all participants communicating status for implementations to key stakeholders.

• Provide product and Supply Chain knowledge to ensure proper implementation and compliance.

• Partner with other areas of the Supply Chain and actively develop and manage relationships with process users business owners J&J affiliates and External Organizations.

• Maintain compliance with all company policies and procedures.

• Ensure audit readiness of global change control process.

• Perform related duties as assigned by supervisor.

Qualifications

Education:

• Minimum of a Bachelors degree required focused degree in technical discipline is preferred

Experience and Skills:

Required:

• Minimum 2 years of related experience including significant experience in pharmaceutical or other related highly regulated industry

• Knowledge of Quality Systems processes inclusive of cGMP and FDA regulations

• Proven ability to perform independent work requiring attention to detail accuracy and scientific judgment

• Possess excellent interpersonal written and oral communication skills with the ability to utilize active listening skills to understand concerns and be responsive in building relationships

• Strong interpersonal skills business partnering influencing and negotiating skills to develop and maintain effective business partnerships

• Proficient digital literacy in Microsoft (MS) Word Excel and PowerPoint

Preferred:

• Aptitude to comprehend analyze and interpret process and systems information technical procedures reports and regulations to make decisions in a GMP environment

• Experience with Comet or other quality management system preferred

• Medical Device or Pharmaceutical experience is desirable ITCI products preferred

• Strong Project Management Skills

• Demonstrated experience to lead complex change implementations confidently

• Proficiency in managing supplier relationships

Other:

• Require up to 10% domestic travel

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 internal employees contact AskGS to be directed to your accommodation resource.

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