Senior Lead Compliance Auditor
Senior Lead Compliance Auditor
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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 worlds 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 candidates 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 initiativetaking 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 Bachelors 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 PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan more detailed information pleaseclick 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 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:
As an EOE/AA employer Labcorp strives for diversity and inclusion 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 of the individual and do not discriminate based upon race religion color national origin gender (including pregnancy or other medical conditions/needs) 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 ouraccessibility siteor contact us atLabcorp Accessibility.
Formore information about how we collect and store your personal data please see ourPrivacy Statement.
Required Experience:
Senior IC
Employment Type
Full-Time
