QA Lead Manager

**Labcorp** is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to transform approaches to patient care.

Our Global Quality Assurance team is looking for our next talent as **QA Lead Manager, based across Europe.**

**Main Job Responsibilities**:

- Assessment and evaluation of Quality Issues in QMS
- Provides QA support and oversight of the investigation, root cause analysis, and CAPA resolution for critical and major Quality issues
- Oversees timely completion of CAPAs and QIs in QMS
- Hosting and supporting of Sponsor Audits and Regulatory Authority inspections
- Providing QA consultation and guidance to the Project team
- Manages the QA to QA relationship with assigned key clients
- Interacts with QA Lead Sr. Manager and above as required for quality issue case progression, issue escalations and client notifications.
- Provides a monthly report of activities to Sr. QA Manager/QA portfolio Manager and in pulling metric data, trending and tracking of QIs for client metrics.
- Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed
- Perform other duties, as assigned by management

**Education**:

- A minimum of a Bachelor’s Degree in Life Sciences preferred
- Experience may be substituted for education.

**Experience**:

- Solid experience in the regulatory environment (experience in GCP roles)
- Ability to manage client responsibilities
- Report and communicates key quality information to Sr. Managers and QA
- Effectively lead and communicate critical issues during client meetings
- Ability to manage difficult conversations and meetings with clients
- Detailed knowledge of specific regulations/multiple regulations
- Ability to influence and negotiate
- Excellent communication, interpersonal, planning, and organizational skills

**Why us**:

- 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.
- Labcorp supported the pharmaceutical industry develop more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today.
- We are also the world´s biggest Central Lab, generating more clinical trial data than all other central laboratories combined.
- LabCorp/Covance were the first in receiving FDA approval to perform COVID19 tests using an at-home collection kit.
- Labcorp have been named by Forbes as one of the World's Best Employers 2020.
- Join us and see why we are uniquely positioned to offer you not only a job, but a stable, long-term international career, and why more than 90% of the top 20 global pharmaceutical companies are repeat customers.

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

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