Vice President of Quality

Position Overview

We are seeking an accomplished Vice President, Quality to provide strategic and operational leadership for Quality across a multi-site, FDA-regulated organization. Reporting to the Chief Operating Officer and serving as a member of the Senior Leadership Team, this executive will be responsible for setting the overall Quality vision, strengthening quality systems, maintaining regulatory compliance, and ensuring consistent standards across the enterprise.

The experience expected from applicants, as well as additional skills and qualifications needed for this job are listed below.

The VP, Quality will work closely with Operations, Compliance, pharmacy, and site leadership to proactively identify risk, resolve quality issues, and maintain a high level of inspection readiness. This leader will also develop and mentor the Quality organization while fostering a culture centered on accountability, collaboration, continuous improvement, and operational excellence.

Key Responsibilities

• Develop and execute an enterprise-wide Quality strategy that supports regulatory requirements, operational objectives, and long-term business growth.
• Provide leadership and oversight for Quality functions across multiple sites, ensuring consistent standards, processes, and expectations throughout the organization.
• Lead the development, implementation, and continuous improvement of the Quality Management System (QMS) in alignment with applicable FDA, cGMP, USP, federal, and state requirements.
• Oversee critical Quality activities, including deviations, investigations, CAPA, change control, customer complaints, validation, supplier/vendor quality, and root cause analysis.
• Establish meaningful Quality metrics and performance indicators to identify trends, assess risk, measure effectiveness, and drive continuous improvement.
• Lead regulatory inspections, external and internal audits, agency interactions, responses to observations, and associated remediation efforts.
• Ensure the organization maintains a proactive state of regulatory and inspection readiness across all operating locations.
• Partner closely with Operations and Compliance leadership to resolve issues, strengthen processes, and improve quality, safety, service, and overall operational performance.
• Provide direction, coaching, and professional development to Site Quality Managers and other Quality professionals, building a strong and scalable Quality organization.
• Promote collaboration between Quality and site leadership while ensuring appropriate accountability and timely resolution of Quality issues.
• Maintain a visible leadership presence across the organization, communicating Quality priorities, performance, risks, and expectations to employees and leadership.
• Champion a culture where quality, integrity, accountability, and continuous improvementare embedded in everyday decision-making.

Qualifications

• Bachelor's degree required; advanced degree preferred.
• 10–15 years of progressive Quality experience within an FDA-regulated pharmaceutical, manufacturing, compounding, or similarly regulated environment.
• 3–5+ years of people leadership experience, with demonstrated success developing Quality professionals and leaders.
• Strong knowledge of FDA regulations, cGMP requirements, USP standards, Quality Management Systems, and applicable federal and state regulations.
• Experience with pharmacy compounding and 503A/503Boperations preferred.
• Demonstrated experience leading regulatory inspections, audits, CAPAs, investigations, and remediation activities.
• Experience providing Quality oversight across multiple sites or facilities strongly preferred.
• Strong understanding of Quality and continuous-improvement methodologies, including Root Cause Analysis, CAPA, risk management, SPC, and Six Sigma principles.
• Demonstrated ability to analyze Quality data, identify trends and root causes, and implement sustainable solutions.
• Proven ability to collaborate with and influence Operations, Compliance, technical teams, and senior leadership.
• Strong executive presence with excellent communication, organizational, analytical, and problem-solving skills. xhyhwjd
• Demonstrated ability to lead change and build a strong, accountable Quality culture.
• Ability to travel up to 50%.