Director of Quality

Job Description

Job Description

Director of Quality | Quality Assurance & Quality Control

Take the Lead in Driving Quality, Compliance & Excellence in Pharmaceutical Manufacturing!

Are you an experienced pharmaceutical quality leader ready to take the next step in your career? We are seeking a highly skilled and results-driven Director of Quality to lead our Quality Assurance (QA), Quality Control (QC), and laboratory operations.

This is an exciting leadership opportunity for a quality professional with extensive pharmaceutical manufacturing experience, strong regulatory knowledge, and a passion for maintaining the highest standards of product quality, safety, and compliance.

The Director of Quality will be responsible for establishing, implementing, and overseeing a comprehensive cGMP-compliant Quality Management System (QMS) in accordance with 21 CFR regulations, FDA requirements, and industry best practices.

This individual will play a key role in ensuring regulatory compliance, maintaining product integrity, driving continuous improvement, and leading cross-functional quality teams.

• Lead and oversee all Quality Assurance, Quality Control, and laboratory operations.
• Manage and mentor QA Managers, QC Managers, Lab Supervisors, Chemists, QA Associates, and Microbiology personnel.
• Recruit, train, develop, and evaluate quality team members.
• Establish performance expectations and promote a culture of accountability and continuous improvement.
• Provide leadership, coaching, and guidance to ensure operational excellence.

• Develop, implement, and maintain a robust Quality Management System aligned with cGMP and FDA regulations.
• Ensure ongoing compliance with 21 CFR requirements and applicable pharmaceutical industry standards.
• Conduct and oversee internal audits, quality assessments, and regulatory compliance activities.
• Develop, review, and enforce SOPs, quality procedures, protocols, and product specifications.
• Establish and monitor manufacturing in-process controls to ensure consistent product quality.
• Review and approve/reject batch records, cGMP documentation, and product release activities.
• Lead investigations involving deviations, nonconformances, and customer complaints, ensuring effective root cause analysis and CAPA implementation.
• Oversee change control, corrective and preventive actions, and quality improvement initiatives.
• Monitor quality performance, identify potential risks, and communicate critical findings and regulatory inspection outcomes to senior leadership.
• Maintain independence and integrity in all quality review, approval, and product release decisions.
• Ensure effective oversight of third-party quality operations and external service providers.

• Strong leadership, communication, decision-making, and team management skills.
• In-depth knowledge of cGMP regulations, FDA requirements, and pharmaceutical quality systems.
• Hands-on experience with deviations, CAPA, change control, audits, and quality investigations.
• Excellent SOP development, documentation, reporting, and organizational skills.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.
• Strong proficiency in Microsoft Office applications and quality management documentation systems.

• Bachelor's degree in Chemistry, Biology, or a related scientific discipline.
• 10+ years of management experience within the pharmaceutical manufacturing industry.
• Extensive knowledge and practical experience with cGMP regulations and FDA compliance requirements.
• Proven experience leading Quality Assurance, Quality Control, and laboratory functions.
• Pharmaceutical manufacturing experience is required.

• Ability to sit, stand, and walk for extended periods, including 8+ hours per day.

If you are a seasoned pharmaceutical quality professional with the expertise to lead quality operations, strengthen regulatory compliance, and drive continuous improvement, we encourage you to apply!

Take the next step in your career and bring your leadership experience to a role where quality truly matters.