Manager, Regulatory Accreditation & Supplier Compliance

ZipRecruiter; Columbus (OH); Remote; USD 95,000 - 115,000; Full time

Job summary

A leading company is seeking a Manager for Regulatory Accreditation & Supplier Compliance who will oversee compliance across the pharmaceutical supplier network. This role is crucial for ensuring all operations adhere to various standards and regulations such as cGMP and URAC. Candidates should possess a relevant degree and significant experience in quality assurance and supplier management, with a focus on continuous improvement and cross-functional collaboration. This position offers a competitive salary and benefits package, promoting a supportive and innovative work culture.

Benefits

Competitive salary & comprehensive benefits

Medical, dental, and vision insurance

401(k) with company match

Generous PTO and paid holidays

Continuous professional development opportunities

Qualifications

• Minimum of 5 years in pharmaceutical quality assurance.
• At least 2 years in supplier management or auditing.
• Strong knowledge of regulatory standards (21 CFR, DSCSA, URAC, NABP).

Responsibilities

• Develop supplier quality management system aligned with FDA and URAC standards.
• Conduct audits and prepare documentation for accreditation processes.
• Maintain compliance databases and continuously monitor changes in regulations.

Skills

Quality assurance

Auditing

Compliance management

Attention to detail

Problem-solving

Education

Bachelors or Masters in Pharmacy, Chemistry, Engineering, or Life Sciences

Tools

eQMS

Job description

Job DescriptionJob DescriptionSalary: $95-115k Salary

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, Regulatory Accreditation & Supplier Complianceplays 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 withcGMP,URAC mail-order standards, andNABP Digital Pharmacy guidelines, as well as oversee the commissioning and validation of automated equipment in the production operation.

How Youll Help Us Improve Healthcare

• Key Responsibilities
  
  • Supplier Quality Management
    • Develop and maintain the supplier quality management system, aligning withFDA,DSCSA,URAC mail-order standards, andNABP 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.
  • 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 byURAC 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:

• Bachelors or Masters 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()
• 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 (1020%)
  

Bonus Skills:

• Familiarity with pharmaceutical and/or medical device environments.
• Experience preparing documentation and SOPs forURAC 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 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!

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