Senior Lead Compliance Auditor

If you have a passion for compliance auditing and a drive for operational excellence, join our growing Quality team as a Senior Lead Compliance 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! At Labcorp, one of the world’s largest and most comprehensive pharmaceutical solutions service companies, you will have an opportunity to build an exciting career while you make a direct impact on the lives of millions.

Job Summary:

The Senior Lead Compliance Auditor is responsible for managing and enhancing our Internal Audit Program. The ideal candidate will possess strong leadership skills, a keen eye for detail, and the ability to oversee complex audit functions. A strong candidate’s background would include either Laboratory or Quality experience working within GLP/GCP regulations, specifically in regard to ISO 15189/ISO 13485 standards. This role requires initiative-taking engagement with stakeholders, ensuring compliance with industry regulations and internal standards while continuously improving auditing processes.
 

Preferred Skills & Qualifications:

• Strong written and verbal communication skills.

• Excellent organizational and project management abilities.

• Strong negotiation and networking skills.

• Experience in training and developing internal auditors.

• Laboratory / Quality background specifically with ISO 15189/ISO 13485 standards.

• Experience with compliance software such as Veeva or Trackwise.

Recommended Certifications:

• ASQ Quality Auditor Certification

• ASQ Quality Manager Certification

• ASQ Quality Engineer Certification

Essential Functions:

Managing the Internal Audit Program:

• Plan and implement the internal audit program.

• Schedule and oversee the approved audit program.

• Develop and clarify audit scopes to ensure comprehensive assessments.

• Approve and assign internal audits to appropriate team members.

Audit Activity Monitoring:

• Lead and manage monthly audit meetings.

• Monitor audit activities, ensuring alignment with regulatory requirements.

Internal Auditor Development:

• Provide training and mentorship for internal auditors.

• Develop audit leads and ensure continuous professional development.

Audit Severity Review with Management:

• Prepare detailed findings for various audits.

• Lead audit review meetings and collaborate with management to address compliance gaps.

Preparedness and Oversight:

• Ensure appropriate stakeholder engagement throughout the audit process.

• Facilitate effective planning and communication with all relevant parties.

Audit Hosting & Regulatory Support:

• Serve as the primary host for internal audits.

• Provide regulatory support and host sponsor audits as required.

Quality Assurance (QA) Support:

• Support and participate in QA projects as needed to uphold compliance standards.

• Laboratory / Quality background specifically with ISO 15189/ISO 13485 standards.

• Experience with compliance software such as Veeva or Trackwise.

Education/Experience Requirements:

• Minimum of a Bachelor's degree in a Pharmacy, Chemistry or Biology related discipline Postgraduate degree (MSG or equivalent) in science or management related discipline, preferable. Experience may be substituted for education.

• Minimum of 8 years in regulatory environment (experience in GXP roles)

  • Regulatory expertise - detailed knowledge of specific regulation/ multiple regulations

  • Experienced Lead Auditor with strategic communication with clients

  • Experience leading process improvement initiatives

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 Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please