Supervisor, Quality Healthcare
Description
Shift
Quality Healthcare Supervisor
The Quality Healthcare Supervisor oversees internal quality systems and procedures related to the compliant and efficient packaging of drug substances and drug products. This role ensures product safety, quality, and legality while supporting site and network-level safety programs and maintaining inspection readiness in alignment with customer and regulatory standards.
Primary Responsibilities
- Oversee quality functions for display and packaging operations, including batch record review, FDA-regulated labeling, and inspections.
- Manage Quality Investigation Reports (QIRs), including root cause analysis, CAPAs, and change controls.
- Conduct periodic product reviews and manage consumer complaints.
- Identify and address QMS gaps; provide compliance guidance for promotional packaging and labeling.
- Support customer product recall and quality hold processes through product traceability and documentation.
- Ensure inspection readiness and compliance with customer QMS standards.
- Propose actions to maintain acceptable quality standards and minimize risk.
- Facilitate use of unreleased product in packaging operations with customer approval.
- Support quality objectives, metrics, and strategic initiatives defined by the customer and company.
- Act as liaison with customer supply planners and internal stakeholders.
- Lead internal Level I audits and SOP reviews per local auditing procedures.
- Provide training to the Quality Department and general facility staff as a subject matter expert.
- Support continuous improvement initiatives using Operational Excellence principles.
- Implement and maintain the company’s Safety Management System; lead site Safety Committee.
- Demonstrate advanced knowledge of FDA standards, GMPs, and quality systems.
- Adapt quickly to changing business needs while managing multiple projects and deadlines.
Education and Experience
- Bachelor’s degree or equivalent in a related field.
- Minimum of three (3) years of experience in a quality and/or compliance role.
- Validation experience (IQ/OQ/PQ) preferred.
- Knowledge of healthcare regulations and FDA requirements preferred.
- Experience with ISO standards preferred.
- Certified Internal Auditor (CIA) or auditing experience preferred.
- ASQ quality certification preferred.
- Combination of office and on-site work required; travel within North America may be necessary.
Requirements, Perks, and Benefits (US – Exempt)
Physical & Cognitive Requirements (With or Without Accommodation)
- Ability to follow policies and procedures.
- Ability to read, write, and interpret information.
- Ability to add, subtract, multiply, and divide.
- Ability to use hands to finger, handle, or feel.
- Ability to sit, walk, or stand for the duration of the shift.
- Must possess visual acuity to perform essential job functions.
- Ability to conduct physical tasks with a full range of motion throughout the warehouse environment.
- Ability to lift/carry items up to 50 pounds.
Equal Opportunity Employer
FedEx Supply Chain, Inc. is an Equal Opportunity Employer, including veterans and individuals with disabilities.
- Know Your Rights
- Pay Transparency
- Family and Medical Leave Act (FMLA)
- Employee Polygraph Protection Act
E-Verify Program Participant
Federal Express Corporation participates in the Department of Homeland Security U.S. Citizenship and Immigration Services’ E-Verify program (for U.S. applicants and employees only). Please click below to learn more:
FedEx Supply Chain is committed to providing access, equal opportunity, and reasonable accommodation for qualified individuals with disabilities in its application procedures, hiring, and other terms and conditions of employment. To request a reasonable accommodation, please contact FSC.TalentAcquisition@fedex.com.
Perks and Benefits at FedEx Supply Chain (FSC)
- Competitive Pay: Competitive wages depending on your location and experience, paid bi-weekly for both full-time and part-time opportunities.
- Tuition reimbursement program
- Holiday pay and accrued paid time off programs offering both Vacation and PTO
- Medical, dental, vision, and voluntary benefits available on day one
- Basic life insurance
- Basic AD&D coverage
- Supplemental Life and Supplemental AD&D
- Short-Term and Long-Term Disability coverage for full-time employees after 180 days of service
- Paid parental leave for both moms and dads
- Paid bereavement and jury duty
Note: Pay is based on several factors including, but not limited to, market location and may vary depending on job-related knowledge, skills, education/training, and a candidate’s work experience.
Job Disclaimer (US)
Please note that this job description is not intended to be an exhaustive list of all duties, responsibilities, or qualifications associated with the position. The Company reserves the right to modify duties or assign additional responsibilities as necessary to meet business needs.
