Remote Quality Compliance Specialist: Regulatory Readiness

Cardinal Health; Frankfort (KY); Remote; USD 38,000 - 48,000; Full time

Benefits offered by this job

Medical/dental/vision

PTO

HSA

401k savings plan

Wages advance with myFlexPay

FSAs

Disability coverage

Work-life resources

Parental leave

Wellness programs

Job summary

Cardinal Health is seeking a Specialist, Quality Compliance to help develop and deploy policies, procedures and programs that minimize risk and ensure compliant operations. The role supports field action activities and maintains GDP and data integrity across quality functions.

Under direct supervision, you will assist on regulatory submissions, audits, and investigations, building knowledge of applicable regulations and internal quality requirements while partnering with senior team members on

Qualifications

• 0-2 years of experience, preferred
• Bachelor's degree in related field, or equivalent work experience, preferred

Responsibilities

• Supports field action activities by preparing, compiling, and coordinating required regulatory reports and submissions for internal review and approval.
• Supports implementation of quality and compliance programs by monitoring adherence to established procedures, policies, and applicable regulatory requirements, and providing guidance to internal stakeholders as needed.
• Collects, analyzes, and summarizes quality and compliance data to support regulatory inquiries, inspections, management review activities, and continuous improvement initiatives.
• Handles and ensures quality of documentation (control, retention, and archival) to support field action activities.
• Promotes and supports adherence to Good Documentation Practices (GDP) and data integrity requirements across quality and compliance activities.
• Assist in the preparation for and execution of regulatory inspections and audits.
• Partners with senior team members on regulatory submissions, compliance activities, process improvements, and investigations to develop knowledge and process of applicable regulations and internal quality requirements.

Skills

Attention to detail

Documentation

Communication

Education

Bachelor's degree in related field

Job description

Cardinal Health is seeking a Specialist, Quality Compliance to help develop and deploy policies, procedures and programs that minimize risk and ensure compliant operations. The role supports field action activities and maintains GDP and data integrity across quality functions.

Under direct supervision, you will assist on regulatory submissions, audits, and investigations, building knowledge of applicable regulations and internal quality requirements while partnering with senior team members on