Supplier Quality Specialist

Gifthealth•Columbus, OH

2d•Hybrid

About The Position

As a Specialist on the Supplier Quality team, you will play a hands-on role in ensuring the quality and compliance of Gifthealth’s supplier network. You will support end-to-end supplier quality activities, from onboarding and qualification through ongoing monitoring and corrective actions, helping Gifthealth maintain the highest standards across its supply chain. This role is responsible for qualifying, monitoring, and maintaining compliance for all vendors and suppliers utilized by the pharmacy. The role ensures that all suppliers meet regulatory, ethical, and operational standards, including ongoing OIG exclusion list verification and annual requalification. 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, healthcare, business, operations management, or related field
2+ years of experience in supplier qualification, auditing, or a compliance
Familiarity with quality management systems (QMS) and quality standards (e.g. FDA 21 CFR Parts 210/211 (GMP for Drugs), Part 820 (Quality System Regulation)
OIG and SAM exclusion verification standards; Good Documentation Practices (GDP)
Excellent communication and vendor relationship management skills.
Strong analytical and documentation abilities
Ability to interpret and apply regulatory guidance to supplier activities
Ability to independently evaluate supplier qualifications and compliance risk.
Ability to collaborate effectively with internal teams and external partners
Strong organizational skills with the ability to manage multiple priorities and deadlines
Excellent written and verbal communication skills for cross-functional and supplier-facing interactions
Proficiency with Microsoft Office, google products and experience with document management or QMS platforms

Nice To Haves

Certified Quality Auditor (CQA) or Certified Supplier Quality Professional (CSQP)
Experience in specialty pharmaceutical, life sciences, or healthcare supplier environments
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.
Experience with conducting supplier audits or third-party quality evaluations
Exposure to supplier audit processes and corrective action management

Responsibilities

Support the qualification and approval process for new suppliers, including documentation collection, risk assessment, and onboarding audits
Performs ongoing OIG exclusion checks and ensures suppliers remain eligible for partnership on an annual basis
Maintain and update the approved supplier list (ASL) and associated qualification records and ensures audit readiness
Coordinate supplier surveys, questionnaires, and self-assessments in alignment with internal standards
Track and report supplier performance metrics and key quality indicators across the approved supplier base
Conduct periodic reviews and re-qualification activities to ensure continued compliance
Monitor supplier-related deviations, complaints, and trends; escalate issues as appropriate
Assist in planning and executing supplier audits (on-site and remote), including preparation of audit agendas and follow-up reports
Support compliance with applicable regulatory standards including FDA, USP, and relevant ISO frameworks
Maintain audit documentation and ensure audit findings are tracked to resolution
Partner with internal teams including Procurement, Regulatory Affairs, and Operations to align on supplier quality expectations
Serve as a point of contact for supplier quality inquiries and day-to-day communications
Contribute to continuous improvement initiatives to strengthen the overall supplier quality program