Onsite Integration & Compliance Lead (FDA/cGMP)

Cencora; Brooks (KY); On-site; USD 60,000 - 90,000; Full time

Job summary

Cencora is seeking an Integration Specialist to coordinate complex, FDA-regulated projects at our Brooks, KY facility. You will ensure regulatory compliance, manage cross-functional teams, and deliver finalized distributions and documentation to clients.

The role emphasizes risk management, process improvement, and clear communication with internal teams and clients to meet project deliverables on schedule.

Qualifications

• Bachelor's degree is preferred or an equivalent of 4 years work experience in quality, project management, analytics, management, or operations, or similar vocations.
• One (1) to three (3) years of experience in related field, preferably quality, project management, analytics, risk, management, or operations, or similar vocations.
• Global understanding of ICS and Specialty 3PL requirements.
• Technical understanding of cGxP, cGDP, cCMP, and ISO / EU requirements.
• Strong ability to identify risk and establish contingencies to manage opportunity.

Responsibilities

• Partner with client / regulatory agencies on needs and verifying ICS ability to meet expectations while ensuring compliance to all cGxP, cGDP, cGMP, and ISO/EU requirements.
• Strong ability to identify risk and establish contingencies to manage opportunity.
• Supports highly FDA regulated, high-priority medium scale projects that require high-levels of cross-functional integration.
• Develops and ensures completion of directives and projects from ICS’s clients into manageable and incremental work tasks that are executed by the ICS Distribution Center associates.
• Completes documents and other quality records to meet project, product, and process requirements.
• Coordinates with various work teams to ensure functional requirements are reflected in the final product.
• Supports the integration of new non-standard work requests into the quality and distribution management systems.
• Ensures project deliverables are accomplished within prescribed timelines
• Effectively manages simultaneous assignments.

Skills

Project coordination

Cross-functional collaboration

Regulatory knowledge

Documentation

Data entry

Education

Bachelor's degree or equivalent

Tools

Salesforce

eQMS

SharePoint

Job description

Cencora is seeking an Integration Specialist to coordinate complex, FDA-regulated projects at our Brooks, KY facility. You will ensure regulatory compliance, manage cross-functional teams, and deliver finalized distributions and documentation to clients.

The role emphasizes risk management, process improvement, and clear communication with internal teams and clients to meet project deliverables on schedule.