Qa Associate Manager, Glp/Gcp-Ed

Do you have GLP/GCP auditing experience? If so, we want you to join our Global QA team as a QA Associate Manager at our Chantilly, VA site.

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.

As part of the QA team, you’ll:

• Ensure appropriately trained resources are available, whilst providing day to day supervision

and guidance for the team, in order to make sure that tasks are completed according to

procedural requirements

• Publish and communicate metrics and ensure appropriate actions are taken, when needed
• Ensure the consistent implementation, use and review of SOPs with respect to Bioanalytical Method Validation and Sample Analysis
• Escalate issues to management in a timely manner implementing appropriate solutions
• Influence functional and operational internal stakeholders to improve quality and increase

efficiencies

• Lead functional process improvement initiatives to drive efficiencies and effectiveness of

Regulatory Compliance & Quality Assurance (RC&QA) processes

• Interpret applicable GxP quality regulations/standards/guidance (GLP/GCP/ICH M10) and create appropriate policies and procedures
• Lead client or regulatory agency interactions

Recruit, train, coach and develop individuals based on their development or business needs

• Complete thorough, timely and well documented performance evaluations providing objective

feedback to the individual

• Ensure Regulatory Compliance and Quality Assurance (RC&QA) management

responsibilities, as indicated in applicable controlled documents, are followed

Education/Qualifications

• 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

• Able to influence QA strategy systems/standards and ability to apply appropriate regulatory knowledge to multiple scenarios
• Knowledge of industry quality systems/standards and able to apply (applicable) regulations in order to monitor compliance
• Experienced GLP/GCP auditor
• 6 years’ in regulatory environment (experience in GLP/GCP roles preferred)
• Excellent interpersonal/organizational skills, e.g. communication, decision making, negotiating, problem solving

Join a leader in Drug Development.

Patients can’t wait. Neither can we.

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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