QA Compliance Lead Auditor, GCP - US REMOTE BASED

Come make a difference today!

Labcorp Drug Development is hiring for US remote-based QA Auditor with GCP experience. This opportunity is ideal for someone with experience as investigator, project, vendor, and or process audit backgound.

What to Expect

Job Responsibilitie 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
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
Other duties as assigned by management.

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.

Experience:

• 8 years in regulatory environment

• Regulatory expertise - detailed knowledge of specific regulation/ multiple regulations

• Experienced Lead Auditor

• Strategic communication with clients

• Experience leading process improvement initiatives

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.

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