GLP/GCP Lead Internal Auditor
Job Responsibilities
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.
Preparedness and Oversight: Ensure appropriate stakeholder engagement throughout the audit process. Facilitate effective planning and communication with all relevant parties.
Audit Hosting and Regulatory Support: Serve as the primary host for internal audits. Provide regulatory inspection support and host sponsor audits as required.
Serious Finding and Audit Report Review with Management: 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.
Audit Program Monitoring: 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.
Qualifications
- Minimum Qualifications: Bachelor's degree in a Pharmacy, Chemistry or Biology related discipline. Postgraduate degree (MSG or equivalent) in science or management related discipline, preferable. 10 years’ experience may be substituted for education. 8 years in regulatory environment (experience in GLP/GCP roles). 4 years Laboratory / Quality background specifically with ISO 15189/ISO 13485 standards.
- Preferred Qualifications: 8 years - Regulatory Industry expertise - GCP/GLP, ISO 15189, ISO 13485 and CAP. 2 years’ experience as Lead Internal Auditor with strategic communication with clients. ASQ Quality Auditor Certification. ASQ Quality Manager Certification. ASQ Quality Engineer Certification.
Why 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. 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.
Benefits
- Medical
- Dental
- Vision
- Life
- STD/LTD
- 401(k)
- Paid Time Off (PTO) or Flexible Time Off (FTO)
- Tuition Reimbursement
- Employee Stock Purchase Plan
Additional Information
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 If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.