Manager, Regulatory Accreditation & Supplier Compliance

Shift: (subject to change based on business needs).

About Gifthealth

Gifthealth is on a mission to bring an easier, more affordable pharmacy experience to patients and providers around the country. In less than a year, we have served thousands of patients and are expanding nationally at a rapid pace. Health is our most precious gift. And our team believes it should be a priority, not a privilege. We are Gifthealth.

Position Overview

The Manager of Supplier Compliance & Validation plays a mission-critical role in ensuring compliance across our pharmaceutical supplier network and validation of automated dispensing and packaging systems. This position will manage supplier qualification, monitoring, and performance evaluations in accordance with cGMP, URAC mail-order standards, and NABP Digital Pharmacy guidelines, as well as oversee the commissioning and validation of automated equipment in the production operation.

How You’ll Help Us Improve Healthcare

Key Responsibilities

Supplier Quality Management

Develop and maintain the supplier quality management system, aligning with FDA, DSCSA, URAC mail-order standards, and NABP Digital Pharmacy compliance requirements.

Lead supplier qualification, including audits, risk assessments, and performance scorecards.

Ensure all suppliers are continuously evaluated and approved through documented procedures including CAPAs and quality agreements.

Auditing & Risk Management

Conduct remote and on-site audits to assess compliance with cGMP, NABP, and URAC criteria.

Prepare documentation for internal inspections, URAC/NABP accreditation audits, and regulatory reviews.

Automated Equipment Validation

Lead commissioning, IQ/OQ/PQ validation, and requalification processes for automation used in dispensing and packaging operations.

Maintain validation protocols and ensure systems meet compliance and performance specifications.

Cross-Functional Collaboration

Partner with procurement, supply chain, engineering, and production teams to assess new suppliers and technologies.

Act as the compliance liaison for any supplier or system-related deviations and investigations.

Documentation & Continuous Improvement

Review and approve CofAs, CofCs, SOPs, and quality agreements.

Maintain compliance databases and documentation as required by URAC mail-order pharmacy accreditation.

Continuously monitor changes in regulatory and accreditation requirements (FDA, URAC, NABP) and adjust procedures accordingly.

Inspection Readiness

Serve as the lead point of contact during supplier-related audits or inspections from regulatory bodies or accreditation agencies.

Maintain audit trails and ensure full traceability across supplier qualification and equipment validation efforts.

A Few Things About You:

Bachelor’s or Master’s in Pharmacy, Chemistry, Engineering, or Life Sciences.

Minimum of 5 years in pharmaceutical quality assurance, including at least 2 years in supplier management or auditing.

Strong knowledge of:

21 CFR Parts 210/211

DSCSA

URAC Mail-Order Standards

NABP Digital Pharmacy accreditation requirements

ISO 13485 (preferred)

Demonstrated experience with quality and compliance management systems (eQMS).

Strong attention to detail, documentation, and problem-solving skills.

Excellent written and verbal communication, including audit reporting and regulatory documentation.

Willingness to travel (10–20%)

Bonus Skills:

Familiarity with pharmaceutical and/or medical device environments.

Experience preparing documentation and SOPs for URAC or NABP digital pharmacy accreditation.

Understanding of cold chain requirements and automation technologies used in pharmacy operations.

Why You'll Love Gifthealth:

Competitive salary & comprehensive benefits

Medical, dental, and vision insurance

401(k) with company match

Generous PTO and paid holidays

Fast-paced, innovative, and supportive work culture

Continuous professional development opportunities

Gifthealth is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Join us in transforming healthcare and making a difference in people's lives. Apply today!