QA Compliance Lead Auditor

We have an excellent opportunity for a QA Compliance Auditor Lead on our team in Madison, WI!

LabCorp Drug Development's work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. Be a part of this life-saving work and help improve patients' lives while growing your career.

Candidates given best consideration will have the following:

• 8 year’s experience in a regulatory environment
• Great attention to detail / multi-tasker
• Highly Organized
• Strong oral and written communication skills
• Professional / Optimistic / Persuasive

Schedule: Core hours are 9:00am-3:00pm with flexibility on start and end times around core hours.

Essential Duties:

• 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 (80% of job)
• Conduct work as identified on the audit activity table (listing on table is not all inclusive but a representative sample)
• Takes lead in generation of global QA policies on interpretation/ application of regulations
• Provide subject matter expertise and leads/influences the ED/CS/CDS/CLS organization by providing guidance and client/authority facing support on specific niche regulatory topics
• Facilities 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
• Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed

Education/Experience:

• Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience).
• 8 years in regulatory environment (or 4 year’s experience in GLP, GCP, or CTTS type roles)
• Experienced GLP Regulations 21CFR PT. 58
• Able to influence QA strategy
• Ability to communicate to groups
• Knowledge of industry quality systems/standards and ability to apply appropriate regulatory knowledge to multiple scenarios

We offer excellent training with extensive benefits including medical/dental/vision plans, ample PTO, tuition reimbursement, 401K with 5% matching, and much more!

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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