Labcorp · 8 hours ago
Quality Compliance Auditor
Indianapolis, IN
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expLabcorp is one of the world’s largest and most comprehensive pharmaceutical solutions service companies, seeking a Compliance Auditor to join their Quality Assurance team. This role is pivotal in ensuring compliance with global regulatory standards and involves leading the internal audit program, collaborating with management, and mentoring junior auditors.
BiotechnologyHealth CareHospitalLife ScienceMedicalPrecision Medicine
Responsibilities
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
Ensure appropriate stakeholder engagement throughout the audit process
Facilitate effective planning and communication with all relevant parties
Serve as the primary host for internal audits
Provide regulatory inspection support and host sponsor audits as required
Document audit findings and develop detailed reports with actionable recommendations
Collaborate with stakeholders to implement CAPAs and monitor their effectiveness
Lead audit review meetings and collaborate with management to address compliance gaps
Lead and manage monthly audit meetings
Monitor audit activities, ensuring alignment with regulatory requirements
Ensure audit and regulatory inspection readiness, in harmony with CLS QA programs and global processes
Provide training and mentorship for internal auditors
Collaborate with QA management and Regulatory Intelligence to ensure regulatory updates are proceduralized, and embraced through staff training and team huddles
Develop audit leads and ensure continuous professional development and compliance awareness
Support, lead and participate in QA projects as needed to uphold compliance standards and continuous improvement strategic initiatives
Qualification
Required
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
Preferred
Strong written and verbal communication skills
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
Laboratory / Quality background specifically with ISO 15189/ISO 13485 standards
Experience with quality management system and regulatory compliance inspections
Experience with compliance software such as Veeva or Trackwise
ASQ Quality Auditor Certification
ASQ Quality Manager Certification
ASQ Quality Engineer Certification
Benefits
Medical
Dental
Vision
Life
STD/LTD
401(k)
Paid Time Off (PTO) or Flexible Time Off (FTO)
Tuition Reimbursement
Employee Stock Purchase Plan
Company
Labcorp
Labcorp specializes in providing physicians with laboratory tests.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$2.85B2024-09-16Post Ipo Debt· $2B
2019-06-04Post Ipo Debt· $850M
1988-07-15IPO
Leadership Team
Adam Schechter
President and Chief Executive Officer
Bill Haas
SVP, Northeastern US and Canada, Labcorp Diagnostics
Recent News
2026-01-22
2026-01-14
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