Senior Specialist, Supplier Quality

Job Function:
Quality;
Job Sub Function:
Supplier Quality;
Job Category:
Professional;
Job Posting Locations:
Gurabo, Puerto Rico, United States of America;
Horsham, Pennsylvania, United States of America;
Raritan, New Jersey, United States of America;
Spring House, Pennsylvania, United States of America;
Wilson, North Carolina, United States of America.

We are searching for the best talent for Senior Specialist, Supplier Quality to join our Innovative Medicine Quality Organization located in Raritan, NJ;
Horsham, PA;
Spring House, PA;
Wilson, NC; or Gurabo, Puerto Rico. Within the JJIM Supplier Quality group, this role is part of a global team focused on supplier lifecycle management of more than 3,500 suppliers on behalf of 20 J&J Innovative Medicines sites worldwide, including responsible for supplier selection, audit qualification, risk management monitoring and issue management with suppliers across the Biotherapeutics, Synthetics and Advanced Therapies platforms.

• 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.
• Collaborates with JJIM Site QA teams on supplier performance and supplier material or services changes.
• Delivers direct support to JJIM local Site during Customer, JJRC and HA inspections as needed.
• Leads and maintains supplier relationships through business initiatives and compliance needs.
• Supports Supplier Quality project scoping and leads project management to achieve goals, objectives and cascade.
• Shapes 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.
• Acts as Supplier Quality Indirect Materials point of contact with site SPOCs related to indirect supplier management.
• Project manages quality initiatives that have impact across JJIM site network in collaboration with site quality teams.
• Delivers change management and communication updates within supplier quality on core activities and projects.
• Builds effective networks and acts as SQ point of contact for Indirect Supplier / Services management with core partners.

• A minimum of a Bachelor’s Degree is required (BSc in Science, Engineering and Technical subjects preferred).
• Experience in end‑to‑end supply chain management or site‑based QA, QC, QMS.
• Knowledge of EQ/SQ QMS required to manage nonconformances, supplier investigations, change control and audits.
• 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 ICH regulation and direct experience of regulatory authorities’ inspections.
• Strong understanding of Biotherapeutics, Synthetics and Advanced Therapies marketed products, including raw material management, DP/DS manufacturing processes, related compliance and quality system management.
• Effective verbal/written communication skills across internal/external stakeholders and leadership teams.
• Excellent analytical skill to identify gaps and root causes of issues and develop and communicate solution proposals.
• Experience working remotely and independently, self‑motivated and comfortable operating within tight deadlines.
• Ability to lead and influence in a high matrix environment.
• Business‑ex mindset (project management, change management, communications).

• Anticipated base pay range: $94,000.00 – $.
• Vacation: 120 hours per calendar year.
• Sick time: 40 hours per calendar year (48 hours if residing in Colorado; 56 hours if residing in Washington).
• 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…