Our client is a global pharmaceutical manufacturer focused on products used in healthcare markets worldwide. They are seeking an experienced Site Quality Director to oversee site-wide Quality Assurance and Quality Control operations while driving compliance, continuous improvement, and operational excellence.
The Site Quality Director is responsible for leading all quality functions supporting commercial sterile manufacturing, laboratory operations, packaging, and warehousing. This individual will ensure regulatory compliance, strengthen quality systems, develop high-performing teams, and foster a culture centered on quality and continuous improvement. This position partners closely with manufacturing, technical operations, and executive leadership while serving as the lead quality professional during regulatory inspections and corporate quality initiatives.
Responsibilities of the Site Quality Director:
- Lead the site’s Quality Assurance and Quality Control organizations.
- Build and maintain a strong quality culture across manufacturing, laboratory, packaging, and warehouse operations.
- Ensure quality systems remain compliant with current GMP regulations and are continuously improved.
- Develop quality metrics, monitor performance, and implement corrective and preventive actions.
- Partner with site leadership to support strategic business objectives.
- Collaborate with corporate quality leadership on global quality initiatives and best practices.
- Prepare the facility for customer, regulatory, and internal audits.
- Serve as the primary contact during regulatory inspections and oversee responses to audit observations.
- Drive investigations, root cause analyses, risk assessments, and quality improvement activities.
- Recruit, mentor, develop, and lead a high-performing quality organization.
- Manage departmental budgets, staffing, and resource planning.
- Support cross-functional initiatives involving manufacturing, engineering, validation, supply chain, and technical operations.
Requirements for the Site Quality Director:
- Bachelor’s degree in Chemistry, Biology, Microbiology, Engineering, or a related scientific discipline (Master’s preferred).
- 12+ years of progressive experience within pharmaceutical manufacturing, including significant leadership responsibility.
- At least 7 years leading Quality Assurance, Quality Control, or both.
- Strong knowledge of current GMP regulations and pharmaceutical quality systems.
- Experience supporting FDA and other international regulatory inspections.
- Demonstrated success leading quality organizations in a regulated manufacturing environment.
- Excellent leadership, communication, and organizational skills.
- Ability to make sound, data-driven decisions while managing multiple priorities.
- Experience supporting sterile pharmaceutical manufacturing operations (preferred)
- Exposure to Operational Excellence, Supply Chain, EHS, or Finance (preferred)
- Experience working within a global manufacturing organization (preferred)
Occupational Code 11-3051.01: Quality Control Systems Managers
Application Instructions: Please apply using the form or send your resume to
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