Supplier Compliance & Validation Manager

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 will ensure supplier

compliance and oversee the validation program of automated equipment used in the Gifthealth production operation. This role will own the overall management of supplier qualification, monitoring, and performance evaluation of suppliers to ensure they meet the required regulatory and quality standards within the pharmaceutical distribution industry. This role will also manage the commissioning and validation of automated equipment that will be implemented within the Gifthealth dispensing and packaging operation.

How You’ll Help Us Improve Healthcare

Key Responsibilities:

• Develop, implement, and maintain the supplier quality management system in compliance with applicable regulations.


• Lead the supplier qualification process, including audits, risk assessments, and performance evaluations.


• Conduct on-site and remote supplier audits and ensure timely closure of findings and CAPAs.


• Collaborate with procurement/supply chain and production teams to evaluate and onboard new suppliers.


• Monitor supplier performance through KPIs, scorecards, and regular reviews.


• Review and approve supplier documentation including quality agreements, specifications, and certificates of analysis (CoAs) and/or certificates of compliance (CofC).


• Manage deviations, complaints, and quality issues related to supplier materials, lead investigations and root cause analysis.


• Serve as the primary point of contact for supplier-related regulatory inspections and internal audits.


• Maintain and continuously improve supplier quality procedures, documentation, and databases.


• Stay updated with evolving regulatory requirements and ensure supplier compliance accordingly.

A Few Things About You:

• Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, Engineering, or related field.


• Solid understanding of cGMP, ISO 13485 and Good Distribution Practices.


• Minimum 5 years of experience in pharmaceutical quality assurance, with at least 2 years in supplier quality or auditing roles.


• Strong knowledge of regulatory requirements.


• Experience with supplier management systems and quality management software.


• Understanding of equipment/automation validation.


• Experience in implementation of a validation program.


• Excellent communication, negotiation, and problem-solving skills.


• Ability to travel. (10-20%)

• Preferred Skills:

• Experience in pharmaceutical and/medical device manufacturing environments.


• Understanding of the Drug Supply Chain Safety Act (DSCSA).


• Familiarity with electronic quality management systems (eQMS).


• Able to work in a fast-paced environment.
  

Our offer to ensure you choose Gift Health:

• Competitive salary and a comprehensive benefits package, including healthcare, dental, and vision insurance


• Retirement savings plan (401k) with company match


• Generous paid time off


• Continuous professional development opportunities in a supportive and innovative work environment
  

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!