Supplier Qualification Manager

GifthealthColumbus, OH
13h$63,000 - $75,000Hybrid

About The Position

At Gifthealth, we're revolutionizing the way people experience healthcare by simplifying the process of managing prescriptions and health services. Our mission is to provide a seamless, personalized, and efficient healthcare experience for all our customers. We're a dynamic, innovative, and customer-centric company dedicated to making a positive impact on people's lives. Position Summary The Supplier Qualification Manager is responsible for qualifying, monitoring, and maintaining compliance for all vendors and suppliers utilized by the pharmacy. This role ensures all suppliers meet regulatory, ethical, and operational standards, including ongoing OIG exclusion list verification and annual requalification. The manager serves as the point of contact for supplier audits, documentation review, and compliance risk assessment. In addition, approximately 30% of this role supports quality initiatives, assisting the Quality Department with document reviews, training support, and process improvement projects to maintain overall compliance readiness. We are seeking a Supplier Qualification Manager to support our vendor and supplier programs. This position plays a key role in vendor compliance, ensuring alignment with organizational goals, operational excellence, and compliance standards.

Requirements

  • Bachelor’s degree in quality assurance, supply chain management, regulatory affairs, or related field (Required)
  • Minimum 3 years of experience in supplier qualification, auditing, or compliance (Required)
  • Knowledge of supplier qualification, auditing, and quality management processes
  • Regulatory compliance requirements for pharmaceutical suppliers
  • OIG and SAM exclusion verification standards
  • FDA 21 CFR Parts 210/211 (GMP for Drugs), Part 820 (Quality System Regulation); and Good Documentation Practices (GDP) (Required)
  • Excellent communication and vendor relationship management skills (Required)
  • Strong analytical and documentation abilities (Required)
  • Ability to interpret and apply regulatory guidance to supplier activities (Required)
  • Ability to independently evaluate supplier qualifications and compliance risk (Required)
  • Ability to collaborate effectively with internal teams and external partners (Required)

Nice To Haves

  • Certified Quality Auditor (CQA) or Certified Supplier Quality Professional (CSQP) (Preferred)
  • Experience conducting supplier audits or third-party quality evaluations (Preferred)
  • Experience in pharmaceutical, life sciences, or healthcare supplier environments (Preferred)
  • Knowledge of ISO 9001 and ISO 13485 standards
  • GxP supplier management and audit principles
  • Familiarity with vendor risk assessment and qualification software, and knowledge of purchasing controls and supplier risk scoring (Preferred)
  • Ability to develop and maintain supplier performance dashboards and audit schedules (Preferred)

Responsibilities

  • Qualifies, evaluates, and approves all suppliers and vendors to ensure compliance with regulatory and internal requirements.
  • Performs ongoing OIG exclusion checks and ensure suppliers remain eligible for partnership on an annual basis.
  • Maintains the supplier qualification database and ensures all supplier files are current, complete, and audit ready.
  • Leads supplier audits and manage communication regarding supplier non-conformance, corrective actions, or quality issues.
  • Collaborates with Procurement, Legal, and Compliance to ensure supplier contracts meet quality and regulatory expectations.
  • Supports Quality Department initiatives, including quality documentation, training material development, and process audits.
  • Assists in maintaining records and data integrity across supplier and quality management systems.
  • Identifies and communicates potential supplier risks, recommending mitigation strategies as needed.
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