QA Lead SR Manager - Remote

Company: Labcorp
Location: Burlington
Posted on: March 19, 2023

Job Description:

Labcorp is seeking a fully-remote QA Lead Sr Manager with strong GCP expertise. This is an individual contributor role with responsibility for the following:

• Contributes in generation of global QA policies on interpretation or application
• Provides subject matter GCP expertise and influences the ED/CS/CDS organization by providing guidance and client/authority facing support on specific regulatory topics and Quality Issues.
• Hosting of external audits/inspections e. g. regulatory inspections, strategic clients
• Supports clients in making regulatory (strategic) decisions/ issue resolution for study problems
• Manages the QA to QA relationship with assigned key client(s)
• Participates in client JOC or governance meetings
• Manages 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) for assigned clients.
• Provides support to Compliance Lead and Sr. management as a contributor or leader of internal functional QA RCQA initiative.
• Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed
• Perform other duties, as assigned by managementEducation & Experience:
  • At least 6 years in regulatory environment (experience in GCP roles required)
  • 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 skillsPay Range: $104,200 to $150,500 annuallyBenefits: 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. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Commissions, and Company bonus where applicable. For more detailed information, please click here.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.For more information about how we collect and store your personal data, please see our Privacy Statement.

Keywords: Labcorp, Burlington , QA Lead SR Manager - Remote, Executive , Burlington, North Carolina