Senior Specialist, Supplier Quality

Senior Specialist, Supplier Quality

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.

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.

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:

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.

Key Responsibilities:

• 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.

Qualifications:

• 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
• 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…