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We are looking for an experienced Audit Manager to support operational integration efforts for a pharmaceutical client in Lenexa, Kansas. This is a contract position focused on documenting workflows, developing Standard Operating Procedures (SOPs), and ensuring compliance with industry regulations during the integration of newly acquired operations. The ideal candidate will play a key role in streamlining processes, enhancing documentation standards, and ensuring audit readiness.
Job Responsibility:
Collaborate with internal teams, including Operations, Quality, Compliance, Supply Chain, and Finance, to document and standardize existing workflows
Develop and format Standard Operating Procedures (SOPs) that align with pharmaceutical industry regulations and compliance requirements
Assist in integrating operational processes between the parent company and the acquired entity, ensuring consistency and alignment
Organize and consolidate documentation into a centralized repository for easy access and improved audit readiness
Participate in cross-functional meetings and working sessions to capture accurate process details and align them with organizational objectives
Provide administrative support, including tracking documentation progress, maintaining process inventories, and contributing to training material development
Ensure all workflows and SOPs meet regulatory standards, including GxP guidelines
Act as a key resource for project coordination and execution, supporting the client’s integration team throughout the contract period
Deliver comprehensive and well-documented workflows and SOPs, ready for internal review and approval
Support audit and compliance efforts by ensuring all documentation is clear, organized, and aligned with industry requirements
Requirements:
Proven experience in operational audits and process documentation within compliance-driven environments
Familiarity with pharmaceutical regulations, including GxP and other industry standards
Strong expertise in developing and formatting SOPs for regulated industries
Certified Information Systems Auditor (CISA) certification preferred
Exceptional collaboration and communication skills, with the ability to work closely with cross-functional teams
Experience in managing documentation repositories and ensuring audit readiness
Ability to function as an extension of the client’s team, providing execution-focused support
Proficiency in project coordination and administrative support
What we offer:
medical, vision, dental, and life and disability insurance