Senior Specialist, Supplier 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 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: Supplier Quality Job Category: Professional All Job Posting Locations: Athens, Georgia, United States of America, Gurabo, Puerto Rico, United States of America, Horsham, Pennsylvania, United States of America, Malvern, Pennsylvania, United States of America, New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of America, Remote (US), Wilson, North Carolina, United States of America Job Description: We are searching for the best talent for Senior Specialist, Supplier Quality to join our Innovative Medicine External Quality/Supplier Quality team located in Raritan, NJ; New Brunswick, NJ; Malvern, PA; Horsham, PA; Athens, GA; Wilson, NC; or Gurabo, Puerto Rico. Remote work options may be considered on a case-by-case basis and if approved by the Company. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. Within the JJIM Supplier Quality group, this role is part of a global team focused on supplier lifecycle management of >3500 Supplier's on behalf of 20 J&J Innovative Medicines sites globally, including responsible for supplier selection, audit qualification, risk management monitoring and issue management with suppliers across the Biotherapeutics, Synthetics and Advanced Therapies platforms. This role is also tasked with supporting NPI growth, business continuity and delivering on quality and compliance goals in compliance with J&J quality and regulatory guidelines. Essential Job Duties and Responsibilities Core responsibilities include development of Supplier Quality strategic priorities and leading execution of deliverables in collaboration with JJIM site personnel, SQ regional quality teams and functional business partners such as Procurement, Planning, MSAT and local JJIM Site Quality teams. Core Responsibilities: (include but are not limited to) Owns supplier lifecycle management for a portfolio of suppliers including supplier selection, qualification, risk management, performance monitoring, issue management and compliance auditing. Owns SQ QMS activities supporting lifecycle such as nonconformances, investigations, change control and audits. Collaborate with JJIM Site QA teams on supplier performance and supplier material or services changes. Deliver direct support to JJIM local Site during Customer, JJRC and HA inspections as needed. Lead and maintain supplier relationships through business initiatives and compliance needs. Support Supplier Quality project scoping and lead project management to achieve goals, objectives and cascade. Shape supplier management practices for platforms with evolving or emerging complexities, or with hybrid supply chains, models, such as with advanced therapies, critical technology and software solutions providers. ​ Act as Supplier Quality Indirect Materials point of contact with site SPOCS related to indirect supplier management. Project manage quality initiatives that have impact across JJIM site network in collaboration with site quality teams. Deliver change management and communication updates within supplier quality on core activities and projects. Build effective networks and act as SQ point of contact for Indirect Supplier / Services management with core partners. Minimum Qualification/Experience A minimum of a Bachelor’s Degree is required. BSc in Science, Engineering and Technical subjects is preferred. E2E supply chain management or site based QA, QC, QMS experience Knowledge on EQ/SQ QMS required to manage nonconformances, supplier investigations, change control and audits. Position requires ability to build and drive collaboration and teamwork across regional sites and global EQ organization. Minimum of 5 years’ in product / supplier lifecycle management across operating supply chain platforms including Biotherapeutics, Synthetics and Advanced Therapies. Practical experience with GMP – and International Conference on Harmonization (ICH) regulation and direct experience of regulatory authorities’ inspections. Must be able to travel up to 10%-15% of the time. Competency/Skill Requirements: Strong understanding of Biotherapeutics, Synthetics and Advanced Therapies marketed products, including raw material management, DP/DS manufacturing processes, related compliance and quality system management. Verbal/written communication skills that are effective across internal/external stakeholders and leadership teams. Excellent analytical skill to identify gaps and root causes of issues and develop and communicate solution proposals. Experienced working remotely and independently, self-motivated and comfortable operating within tight deadlines. Ability to lead and influence in a high matrix environment Bus Ex mindset – (Project management, change management, communications). If you are under 18 years of age, you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check. 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 yo