Labcorp QA Audit Manager- (GCP) in Topeka, Kansas
Oversees designated global audit programs for compliance to the master audit plan (procedures, execution, QC, compliance to process, etc.)
Identifies the scope and leads global audits and associated audit team
Facilitates prioritization of global projects for risk-based audits
Ensure the consistent implementation, use and review of SOPs
Escalate issues to management in a timely manner implementing appropriate solutions, including preventative actions
Negotiate with functional and operational internal stakeholders to improve quality and increase efficiencies
Analyze and interpret data in order to lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance & Quality Assurance (RC&QA) processes
Lead and effectively manage constructive crucial interactions with clients or regulatory agencies
Lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance & Quality Assurance (RC&QA) processes
Interpret applicable quality regulations/standards and create appropriate policies and procedures
Ensure Regulatory Compliance and Quality Assurance (RC&QA) management responsibilities, as indicated in applicable controlled documents, are followed
Perform other duties, as assigned by management
A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience).
Experience may be substituted for education.
8 years in a GCP regulatory environment.
Experience & regulatory expertise of industry quality systems/standards.
Experience with hosting internal, external and FDA audits.
Ability to interpret applicable regulations/standards.
Experience in leading process improvement initiatives.
Ability to communicate and negotiate internal stakeholders effectively.