QA Senior Compliance Specialist

Join our Labcorp Quality department as a QA Senior Compliance Specialist!

Do you have 8 years’ experience in a regulated environment in GxP roles? Do you have extensive experience working with FDA and EPA inspectors? Do you have strong knowledge regarding the regulatory body and processes to maintain compliance and interact and host remote audits along with working with regulatory inspectors? If so, then take your career to the next level at Labcorp as a QA Senior Compliance Specialist.

Join an exceptional organization and an exceptional Quality department.

The role is critical to client service, process improvement oversight and regulatory compliance expertise required for QA monitoring and non-compliance assessment. Extensive face to face with Regulatory and Federal Agencies and strong ability to navigate root cause analysis and responses to FDA and EPA is necessary!

The individual in this role verifies compliance with standard operating procedures (SOPs) and regulations by performing all types of inspections/audits. The auditor hosts external audits/inspections, leads generation of global QA policies, and provides subject matter expertise for the organization. The statements below reflect the general responsibilities and requirements of the identified position but may not describe all the work requirements that may be inherent in the job. It is the responsibility of all employees to comply with all applicable regulations e.g., Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP) in the performance of their role.

Duties and Responsibilities:

• Conducts all types of inspections/audits, hosts external audits/inspections, and assists with the facilitation of audit responses, and prepares and delivers training in performance of audits. 

• Takes lead in generation of global QA policies on interpretation/ application of regulations. 

• Provides subject matter expertise and leads/influences the 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) and facilitates and reviews responses to the audits. 

• Manages (for own area of expertise) / participates (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 responsibilities, as indicated in applicable controlled documents, are followed.

Minimum Education and Experience Required:

• Minimum: Bachelor’s Degree Pharmacy, Chemistry or Biology related discipline 

• Postgraduate degree (MSC or equivalent) in science or management related discipline preferable 

• Experience may be substituted for education 

• 8 years in a regulatory environment (experience in GxP roles) 

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

• Extensive face to face expereince with Regulatory and Federal Agencies (FDA and EPA)

• Strong ability to navigate root cause analysis and responses to regulatory bodies

Skills and Competencies:

• Provides strategic communication with clients 

• Knowledge of multiple operational areas 

• Excellent interpersonal/organizational skills, e.g., communication, decision making, negotiating, problem solving 

• Experience leading process improvement initiatives

Labcorp is recognized as one of the world’s best employers and named as one of the most innovative companies. At Labcorp, you will find a rewarding role that allows you to make a difference in people’s lives, including your own!

Application Window: May 6th

Pay Range: $80,000 TO $110,000/ANUALLY

All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. 

Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for com