Director of Quality

Jobster LLC

Gulfport (MS)

On-site

USD 120,000 - 180,000

Full time

19 hours 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

Lead and oversee all quality operations within a pharmaceutical manufacturing environment by developing, implementing, and maintaining a cGMP-compliant quality system aligned with regulatory standards, customer requirements, and industry best practices.

About the Role

Responsible for establishing and maintaining a cGMP Quality Management System in compliance with 21 CFR regulations and U.S. Food and Drug Administration standards. The role ensures product quality, regulatory compliance, and continuous process improvement while leading quality teams and supporting organizational objectives.

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
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
Required Skills
  • Strong communication, leadership, and teamwork abilities
  • Excellent organizational and time management skills
  • Knowledge of quality systems, including change control, deviations, and CAPA processes
  • Ability to manage multiple priorities in fast-paced environments
  • Proficiency in SOP development, documentation, and reporting
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