QA Manager (Senior GCP Auditor) - US Remote based

Company: Labcorp
Location: Burlington
Posted on: March 10, 2023

Job Description:

The Quality Assurance Manager Oversees designated global GCP audit programs for compliance to the master audit plan (procedures, execution, QC, compliance to process, etc.). Identifies the scope and leads global audits and associated audit team and facilitates prioritization of global projects for risk-based audits. Ensures the consistent implementation, use and review of SOPs.

What to Expect

• Escalate issues to management in a timely manner implementing appropriate solutions, including preventative actions
• Negotiate with functional and operational internal stakeholders to improve quality and increase efficiencies
• Analyse and interpret data in order to lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance & Quality Assurance (RC&QA) processes
• Lead and effectively manage constructive crucial interactions with clients or regulatory agencies
• Lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance & Quality Assurance (RC&QA) processes
• Interpret applicable quality regulations/standards and create appropriate policies and procedures
• Ensure Regulatory Compliance and Quality Assurance (RC&QA) management responsibilities, as indicated in applicable controlled documents, are followed
• Mentor/train less experienced auditors
• Perform other duties, as assigned by management
• Travel 30-40% Regional (Americas)
• 100% home-based-Remote Role
  
  Education/Qualifications
  • A minimum of a Bachelor's Degree in Life Sciences preferred (or equivalent Life Science experience
  • Experience may be substituted for education.
    Experience
    • 8 years in regulatory environment (experience in GCP roles)
    • Experience & regulatory expertise of industry quality systems/standards
    • Ability to interpret applicable regulations/standards
    • Experience in leading process improvement initiatives
    • Ability to communicate and negotiate internal stakeholders effectively
      
      US Pay Range: $100,000-$155,000 Benefits: 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), Company bonus where applicable. For more detailed information, please click here . As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.
      Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.
      In July 2022, Labcorp announced its intention to spin off its clinical development business as a separate public company, subject to the satisfaction of certain customary conditions. Fortrea will become the new brand identity for our Clinical Development business in connection with the spin-off, which is expected in mid-2023.
      We believe that the exceptional is possible when you have the right partner, so we are looking for the right people to help build a transformative force in Clinical Development. 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 .

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