Director of Quality

Jobster

About the Company

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

Preferred Skills

None specified

Pay range and compensation package

None specified

Equal Opportunity Statement

None specified

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Vacancy posted 4 days ago

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