Supplier Qualification Lead

Hikma Pharmaceuticals USA Inc.•Cherry Hill, NJ

6d•$66,600 - $133,750

About The Position

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.

Requirements

Bachelor’s in Engineering, Chemistry, Microbiology, Pharmacy, or related scientific discipline (advanced degree preferred).
8+ years in Supplier Quality / Quality Assurance / Quality Systems in pharma preferably.
Demonstrated experience leading: supplier qualification/onboarding programs supplier audits and CAPA follow-up quality agreements supplier change notification processes
Working knowledge of US cGMP expectations relevant to incoming materials and quality unit responsibilities (21 CFR Part 211).
Strong investigation/RCA capability (e.g., 5-Why, Fishbone, fault tree) and practical risk management mindset

Nice To Haves

Lead auditor qualification (e.g., ASQ CQA, IRCA) or equivalent auditing credentials.
Experience with extractables/leachable, container-closure systems, or single-use systems in sterile manufacturing.
Experience implementing supplier scorecards and supplier risk segmentation models.
Executive-level communication with suppliers and internal leadership
High judgement and comfort making risk-based decisions
Strong cross-functional influencing (Quality, Procurement, MS&T, Validation, QC/QA, Regulatory)
Structured problem-solving; ability to drive closure and measurable outcomes

Responsibilities

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 qualification plans (desktop assessment → on-site audit → quality agreement → sampling/testing strategy → approval) supplier capability evaluation 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) required comparability, qualification, or re-validation actions cross-functional approvals and documented closure
Compliance, Inspection Readiness & QMS Integration
Maintain inspection readiness for supplier controls across the network; serve as SME during regulatory inspections and internal audits (supplier qualification, incoming controls, supplier oversight).
Ensure supplier quality processes align with QMS requirements and support Quality Unit responsibilities for approval/rejection of materials and for oversight of contracted operations.
Continuous Improvement
Identify and execute supplier quality improvement projects (defect reduction, right-first-time COA, reduced incoming failures, audit cycle-time reduction).
Standardize tools/templates across sites: supplier risk models, qualification checklists, audit reports, scorecards, and supplier status governance.

Benefits

Annual performance bonus, commission, and share potential
Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
3 personal days (prorated based on hire date)
11 company paid holidays
Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
Employee discount program
Wellbeing rewards program
Safety and Quality is a top organizational priority
Career advancement and growth opportunities
Tuition reimbursement
Paid maternity and parental leave