QA Manager (IC)

Company: Labcorp
Location: Durham
Posted on: September 6, 2021

Job Description:

Job Overview:

Labcorp Drug Development is seeking candidates for a QA Manager. The QA Manager will be remotely located (home-based) anywhere within the United States.

• Ensure the consistent implementation, use and review of SOPs.
• 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.
• Analyze 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.
• Perform other duties, as assigned by management.
• Travel essential to Labcorp Drug Development by Labcorp offices primarily located in Princeton, NJ and Druham, NC with respect to adhering to pandemic restrictions.

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.
• Experience with hosting internal, external and FDA audits.
• Ability to interpret applicable regulations/standards.
• Experience in leading process improvement initiatives.
• Ability to communicate and negotiate internal stakeholders effectively.

Keywords: Labcorp, Durham , QA Manager (IC), Other , Durham, North Carolina