Title:  Supplier Qualification Lead

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.

Key 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.

Scope of Suppliers (Typical)

• API/excipients, critical raw materials for sterile injectable formulations

• Primary packaging (vials, stoppers, seals, prefilled syringe components, IV bags/ports, ampoules)

• Single-use assemblies, filters, tubing, connectors, sterilized consumables

• Critical services: sterilization providers, testing labs, calibration/qualification services (as applicable)

Hikma’s injectables operations include broad sterile capabilities and technologies across vials/syringes/bags/ampoules, reinforcing the need for robust supplier controls. 

Qualifications:

We value the skills and experiences candidates bring to the table.  While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

• 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

Preferred Qualifications:

• 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.

Competencies

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

Compensation:

Base Salary: to $66,600 to $ 133,750 annually.  The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process.

What We Offer*:

• 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

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment.  Benefits are subject to change as well as specific plan or program terms.

Recruiters:

Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions.  In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.

Equal Opportunity Employer:

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer.  Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.