QA Auditor (HOST ROLE), GCP – REMOTE US based opportunity
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Labcorp Drug Development is hiring for QA Compliance Lead Auditor, with seasoned background in GCP (preferred experience in GCP hosting) and regulatory policies. This is a remote US based opportunity (with preference for candidate located in or near Durham, NC or Princeton, NJ).
Ideal candidate is looking to increase leadership, continue to enhance day-to-day work specific to GCP / hosting, and in regulatory and must be detail oriented with strong communication skills.
Job Responsibilities include but not limited to:
Takes lead in generation of global QA policies on interpretation/ application of regulations
Provide subject matter expertise and leads/influences the CDS organization by providing guidance and client/authority facing support on specific niche regulatory topics
Hosts (i.e. for cause inspection, non-standard authority inspections, country-specific or scope of inspection) external audits/inspections e.g. regulatory inspections, strategic clients.
Facilitates and reviews responses to the audit.
Leads the reporting of quality metrics and implementation of necessary corrective actions and/or process improvements via appropriate forum (e.g. Monthly Reports, Site Quality Review, Liaison meetings).
Manage (for own area of expertise) / participate (for multi-regulatory topics) in broad scope global Quality initiative(s) aimed at improving compliance and/or efficiency of the QA organization
Acts as a backup for QA Manager; provides monthly report of activities to QA Manager; performs other related duties as assigned
Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed
Travel to LDD facilities (Durham, NC and/or Princeton, NJ) may be required to host/support onsite client audits / regulatory inspections (~20%); most audits may be hosted remotely
Qualifications / Experience:
8 years in regulatory environment (experience in GCP roles)
Regulatory expertise – detailed knowledge of specific regulation/ multiple regulations
Experienced Lead Host
Strategic communication with clients
Experience leading process improvement initiatives
Qualifications / Education:
A minimum of a Bachelor’s Degree in a Pharmacy, Chemistry or Biology related discipline
Postgraduate degree (MSC or equivalent) in science or management related discipline, preferable
Experience may be substituted for education.
US Pay Range: $95,000 -$148,000
Benefits: All job offers will bebased on a candidate’s skills and prior relevant experience, applicabledegrees/certifications,as well as internal equity and market data.Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. For more detailed information, please click here.
As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.
Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.
In July 2022, Labcorp announced its intention to spin off its clinical development business as a separate public company, subject to the satisfaction of certain customary conditions. Fortrea will become the new brand identity for our Clinical Development business in connection with the spin-off, which is expected in mid-2023.
We believe that the exceptional is possible when you have the right partner, so we are looking for the right people to help build a transformative force in Clinical Development. www.fortrea.com
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. We encourage all to apply.