Supplier Quality Specialist

Supplier Quality Specialist

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.

Role Overview

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.

Key Responsibilities

Supplier Qualification & Onboarding

• 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

Ongoing Supplier Monitoring

• 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

Audits & Compliance

• 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

Cross-Functional Collaboration

• 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

Qualifications

Required

• Education: Bachelor's degree in quality assurance, healthcare, business, operations management, or related field
• Experience: 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

Preferred

• Licensure/ Certification: Certified Quality Auditor (CQA) or Certified Supplier Quality Professional (CSQP) (Preferred)
• 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

Work Environment

• Location: Hybrid
• Schedule: 8:00am- 5:00pm Monday – Friday with night and weekend hours on occasion as determined by the needs of the business.
• Travel required 30% of the time to meet with vendors and audit sites.

Key Essential Functions

• Must be able to remain in a stationary position for extended periods while writing or reviewing documentation
• Must be able to work on a computer for the entire shift
• Must be able to attend virtual meetings with cross-functional teams.