ITCI Change Control Facilitator

Johnson & Johnson Innovative Medicine•Horsham, PA

21h•$65,000 - $104,650

About The Position

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 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. 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 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.

Requirements

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

Nice To Haves

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

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.

Benefits

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)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
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