Lead Internal Auditor, GLPGCP

Labcorp is a global leader in laboratory services providing the insights and answers that help healthcare providers patients researchers pharmaceutical companies and health systems make confident decisions and improve outcomes. Through our unparalleled science data technology and laboratory network we advance diagnostics accelerate innovation and help address some of the worlds most important health challenges. As we shape the future of healthcare we are leveraging advanced technologies intelligent digital solutions and data-driven innovation across our operations to enhance how work gets done and deliver greater value to customers and patients. With our global scale and deep expertise youll have the opportunity to do meaningful work grow your career and make a real impact on peoples health around the world. Together were improving health and improving lives.

Labcorp is seeking a Lead Internal Auditor GLP/GCP to join our team in Indianapolis IN!

Work Schedule: Monday Through Friday 8-5 pm

Job Responsibilities:

The Lead Internal Auditor plays a pivotal role as part of our Quality Assurance team in ensuring that clinical research laboratory testing operations comply with global regulatory standards and industry-recognized best practices including GCP/GLP ISO 15189 ISO 13485 and CAP.

This position leads the internal audit program execution drives process improvements collaborates with management to implement audit strategies mentors junior auditors and collaborates with cross-functional teams to uphold quality and regulatory integrity across clinical laboratory testing and operational environments. The ideal candidate will possess strong leadership skills a keen eye for detail and the ability to oversee complex audit functions in a fast-paced environment with minimal direction. This role requires initiative-taking timely and responsive engagement with stakeholders ensuring compliance with industry regulations and internal standards while continuously improving auditing processes.

Focus areas include:

• Managing the Internal Audit Program

• Preparedness and Oversight

• Audit Hosting & Regulatory Support

• Severity Finding and Audit Report Review with Management

• Audit Program Monitoring

• Internal Auditor Development

• Quality Assurance (QA) Support

Minimum Qualifications:

• Bachelors degree in a Pharmacy Chemistry or Biology.

• 8 or more years of experience in GLP/GCP regulatory environment.

• 4 or more years of experience in Laboratory or Quality with ISO 15189/ISO 13485 and CAP.

Preferred Qualifications:

• Masters degree in science or management

• 8 or more years of experience in regulatory environment with GCP/GLP ISO 15189 ISO 13485 and CAP

• 2 or more years of experience as a Lead Internal Auditor

• ASQ Quality Auditor Certification

• ASQ Quality Manager Certification

• ASQ Quality Engineer Certification

Additional Job Standards:

• Ability to demonstrate effective communication verbally and written with an emphasis on strategic communication with clients.

• Excellent organizational and project management abilities.

• Strong negotiation influencing and networking skills.

• Demonstrative skills include risk management application experience including risk-based auditing methodologies.

• Experience in training and developing internal auditors.

• Experience with quality management system and regulatory compliance inspections

• Experience leading process improvement initiatives.

• Experience with compliance software such as Veeva or Trackwise.

At Labcorp you can expect the following:

• Innovative Environment: Join a leading healthcare organization committed to driving innovation through internal development to help improve health and improve lives.

• Collaborative Culture: Work in a dynamic inclusive environment that values diverse perspectives and fosters collaboration.

If you have a passion for compliance auditing and a drive for operational excellence join our growing Quality team as a GLP/GCP Lead Internal Auditor and take your career to the next level at Labcorp. Imagine being involved in innovation and projects that change the course of our industry daily!

Benefits:Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical Dental Vision Life STD/LTD 401(k) Paid Time Off (PTO) or Flexible Time Off (FTO) Tuition Reimbursement and Employee Stock Purchase regularly scheduled to work less than 20 hours Casual Intern and Temporary employees are only eligible to participate in the 401(k) more detailed information pleaseclick here.

Labcorp is proud to be an Equal Opportunity Employer:

Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race religion color national origin sex (including pregnancy childbirth or related medical conditions) family or parental status marital civil union or domestic partnership status sexual orientation gender identity gender expression personal appearance age veteran status disability genetic information or any other legally protected characteristic. Additionally all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.

We encourage all to apply

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