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.

This is an Onsite position at 8211 Scicor Drive, Indianapolis, IN.

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 click here. 

Why People choose to work at Labcorp: 

At Labcorp, it is our people that make us great – it is what our clients, our partners and, most importantly, what our employees say. Here, you will have the opportunity to collaborate with extraordinary people with diverse viewpoints. You will discover your own outstanding potential as we build an even stronger organization with industry leaders from early development to the clinic and beyond. We help our clients develop medicines that improve health and improve lives of their family and friends. 

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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