Head Of Quality

Head Of Quality

The Head of Quality leads and oversees all quality functions across the organization, including Quality Assurance, Quality Control, Microbiology, Validation, Compliance, and the Quality Management System (QMS). This executive role ensures full compliance with FDA cGMP regulations, ICH guidelines, data integrity requirements, and internal quality standards while maintaining continuous inspection readiness in a sterile pharmaceutical manufacturing environment. The Head of Quality drives a culture of quality excellence, operational efficiency, and continuous improvement, and serves as a key partner to cross-functional teams on business-critical initiatives.

Responsibilities

• Provide strategic direction and oversight for all Quality operations, setting a clear vision and ensuring alignment with overall business objectives.
• Establish departmental goals, key performance indicators (KPIs), and long-term quality strategies that support growth, compliance, and operational excellence.
• Lead, mentor, and develop Quality leaders and staff, fostering a culture of accountability, collaboration, and continuous improvement.
• Ensure appropriate resource allocation and organizational structure to support business growth, new product introductions, and compliance initiatives.
• Direct the development, implementation, and continuous improvement of the Quality Management System (QMS) across the organization.
• Oversee core quality system processes including deviations, CAPAs, change controls, document management, training, risk management, complaints, recalls, supplier quality, management reviews, and internal audits.
• Ensure all quality systems remain effective, compliant, and in a state of ongoing inspection readiness.
• Provide oversight for Quality Assurance activities such as batch record review, batch disposition, product release, line clearance, shop-floor QA operations, investigations, change controls, and validation documentation.
• Ensure strict compliance with approved procedures, regulatory requirements, and current Good Manufacturing Practices (cGMP).
• Lead Quality Control and Microbiology operations, ensuring compliant testing of raw materials, packaging components, in-process materials, finished products, environmental monitoring, and stability programs.
• Review and approve investigations related to out-of-specification (OOS) and out-of-trend (OOT) results, ensuring robust root cause analysis and effective corrective actions.
• Oversee analytical method validation, laboratory compliance, and continuous improvement initiatives within QC and Microbiology laboratories.
• Provide quality oversight for validation and qualification programs, including facilities, utilities, equipment, cleaning processes, computerized systems, and manufacturing processes.
• Review and approve validation strategies and lifecycle documentation to ensure alignment with regulatory expectations and industry best practices.
• Maintain compliance with FDA regulations (21 CFR Parts 210 and 211), ICH guidelines, USP standards, and data integrity principles (ALCOA+).
• Monitor evolving regulatory requirements and industry guidance, and implement necessary enhancements to quality systems, procedures, and practices.
• Lead FDA, customer, and third-party audits and inspections, acting as the primary quality representative and ensuring effective communication and responses.
• Coordinate inspection preparation activities and ensure timely, thorough, and effective responses to audit observations and regulatory findings.
• Oversee supplier quality management programs, including supplier qualification, quality agreements, vendor audits, and ongoing supplier performance monitoring.
• Ensure reliable sourcing of GMP-compliant materials and services through robust supplier oversight and risk management.
• Collaborate closely with Manufacturing, Engineering, Supply Chain, Warehouse, Validation, and Regulatory Affairs to support quality objectives, technology transfers, process improvements, and commercial readiness initiatives.
• Serve as a key quality representative for business-critical projects and operational decision-making, providing expert guidance on quality and compliance risks.
• Recruit, develop, and retain high-performing quality professionals across all quality functions.
• Establish succession planning initiatives and promote ongoing GMP, technical, and leadership development programs for the quality organization.
• Track and manage key performance indicators (KPIs) such as FDA and customer inspection outcomes, CAPA effectiveness, deviation closure timelines, batch release cycle times, training and GMP compliance rates, audit readiness, customer complaint trends, supplier quality performance, and data integrity compliance metrics.

Essential Skills

• Minimum of 15 years of experience within pharmaceutical manufacturing, with a strong focus on quality functions.
• At least 8 years of progressive leadership experience managing Quality organizations in a regulated environment.
• Proven experience within…