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Quality Assurance Manager

Company: Barrington James
Location: Raleigh
Posted on: February 23, 2021

Job Description:

One of my clients are looking for someone that wants to step into a QA Management position and join a fast-growing team. The company themselves are extremely well regarded, growing from strength to strength with a deep product line. This position would allow you to join them in a very visible role, being tasked with:

  • Bachelor's degree or equivalent experience in related sciences
  • At least 5 years' of GCP auditing experience
  • Has worked with Quality Management Systems
    • Collaborate with the Director, QA to develop and implement the quality management system (QMS) and establish quality goals and initiatives, risk assessments and ensure regulatory compliance.
    • Work with the Director, QA to develop an audit strategy and implement inspection and audit readiness activities.
    • Oversee the QA audit program, including development and maintenance of the company master audit schedule, audit plan development, oversight of auditors and/or consultants and endure deliverables meet quality standards. Additional duties include conducting and hosting of audits as needed and ensuring compliance with associated processes.
    • Oversee client qualification, routine, and ad-hoc audits as well as external qualification and ongoing audits of vendors and client partners.
    • Assist with the management of the document control process, CAPA and deviations process, training program and initiatives and oversight of the vendor qualification/re-qualification process.
    • Ensure standard procedures are updated to reflect technological changes, regulatory trends, and best practices.
    • Interface with regulatory agencies, clients, internal and external stakeholders, and vendors, as needed.
    • Support company regulatory GCP inspections and serve as the liaison to the Food and Drug Administration (FDA) and other regulatory agencies.
    • Work with the Director, QA to establish, maintain, and distribute metrics (process capability, control charts, measurement quality) for monitoring quality system effectiveness.
    • Advise/coach/train staff to ensure compliance with internal and external policies, laws, and regulations.
    • Achieve financial objectives by preparing the QA budget, scheduling expenditures, analyzing variances, and initiating corrective actions.
      If you would like to arrange for an exploratory conversation, please get in touch directly at or for more details. I look forward to hearing from you.

Keywords: Barrington James, Raleigh , Quality Assurance Manager, Executive , Raleigh, North Carolina

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