Director of Quality: cGMP & Continuous Improvement

Jobster LLC

Gulfport (MS)

On-site

USD 120,000 - 180,000

Full time

5 days ago
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Job summary

Jobster LLC is seeking a seasoned quality leader to head cGMP compliance in a pharmaceutical manufacturing setting. The role focuses on establishing, implementing, and maintaining a robust Quality Management System aligned with 21 CFR standards and customer requirements.

You will lead quality teams, drive continuous improvement, manage deviations and CAPA, and ensure accurate product release decisions in line with regulatory expectations.

Qualifications

  • Bachelor's degree in Chemistry, Biology, or a related field.
  • 10+ years of management experience in pharmaceutical manufacturing.
  • Expert knowledge of cGMP and regulatory requirements.
  • Experience with Microsoft applications and quality documentation systems.
  • Pharmaceutical industry experience required.

Responsibilities

  • Establish and maintain the Quality Management System and ensure ongoing cGMP compliance.
  • Audit quality processes, policies, and procedures to maintain operational control.
  • Develop and enforce procedures, protocols, and specifications, including third-party oversight.
  • Implement and monitor manufacturing in-process controls.
  • Review and approve/reject cGMP documentation, batch records, and product release decisions.
  • Lead investigations of deviations, nonconformance, and customer complaints with root cause analysis.
  • Report quality risks, system performance, and regulatory inspection outcomes to leadership.
  • Maintain independence in quality review and approval activities.

Skills

Leadership
Communication
Time management
SOP development
Documentation

Education

Bachelor's degree in Chemistry, Biology, or related field

Tools

Microsoft applications

Job description

Jobster LLC is seeking a seasoned quality leader to head cGMP compliance in a pharmaceutical manufacturing setting. The role focuses on establishing, implementing, and maintaining a robust Quality Management System aligned with 21 CFR standards and customer requirements.

You will lead quality teams, drive continuous improvement, manage deviations and CAPA, and ensure accurate product release decisions in line with regulatory expectations.

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