Supplier Qualification Lead

Overview

Job Title: Supplier Qualification Lead

Location: Cherry Hill

Job Type: Full-time

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.

Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Supplier Qualification Lead to join our team. In this role, you will be accountable for end-to-end supplier qualification, supplier oversight, and supplier performance management for Hikma’s US Injectables network, ensuring compliant, reliable supply of raw materials, primary packaging, single-use systems, and critical services supporting sterile injectable manufacturing.

The role drives a harmonized supplier quality strategy across US Injectables operations, with strong partnership to Site Quality, Procurement, Manufacturing, QC, MS&T, Validation, and Regulatory.

• Supplier Qualification & Onboarding (Core)
  • Own and continuously improve the Supplier Qualification Program for US Injectables (materials, components, and services), aligned to cGMP expectations for control of components and containers/closures.
  • Lead supplier onboarding activities including supplier risk assessment and criticality classification.
  • Develop qualification plans (desktop assessment → on-site audit → quality agreement → sampling/testing strategy → approval).
  • Evaluate supplier capability for sterile injectables requirements (e.g., particulate/bioburden controls, extractables/leachable awareness, sterilization validations where relevant, GDP for cold chain materials if applicable).
  • Ensure site procedures support compliant receipt, sampling, testing/examination, and release of incoming materials, consistent with Part 211 expectations.

• Supplier Oversight, Performance & Governance
  • Establish and lead Supplier Performance Management (scorecards, defect trending, OOS/OOE linkage to suppliers, on-time delivery/quality performance, complaint trends, audit findings).
  • Drive supplier business reviews for critical suppliers and escalate performance risks via defined governance.
  • Own supplier-related deviation investigations support, ensuring robust RCA and systemic corrective/preventive actions.

• Supplier Audits & Audit Strategy
  • Develop and execute a risk-based audit plan for suppliers and outsourced activities supporting injectables (materials, labs, sterilization, contract services), ensuring appropriate audit coverage and follow-up.
  • Lead supplier audits (or oversee qualified auditors), including audit reports, observations, and timely closure of supplier CAPAs.
  • Ensure audit outcomes are integrated into supplier status decisions (approved/conditional/disqualified).

• Quality Agreements & External Party Management
  • Lead development, negotiation, and lifecycle management of quality agreements with suppliers/contract facilities, ensuring clear delineation of CGMP responsibilities and communication pathways, consistent with FDA expectations for contract manufacturing arrangements.
  • Ensure agreements cover: change notification requirements, deviation/complaint communication, audit rights, documentation/traceability expectations, and testing/COA expectations.

• Change Control & Material/Component Change Management
  • Own the regional process for supplier change notifications (materials, manufacturing site changes, process changes, specs, sterilization changes, packaging changes), including impact assessments (quality/regulatory/validation) and required comparability, qualification, or re-validation actions, with…