Assistant Manager Of Quality Jobs in Boca Raton, FL

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 sterile injectable manufacturing environments, including aseptic processing and contamination control.
• Demonstrated success leading FDA inspections and regulatory interactions, including preparation, execution, and follow-up.
• Deep knowledge of current Good Manufacturing Practices (cGMP) and FDA regulations, specifically 21 CFR Parts 210 and 211.
• Strong expertise in Quality Management Systems (QMS), including design, implementation, and continuous improvement.
• In-depth understanding of ICH guidelines, USP standards, and Annex 1 requirements related to sterile manufacturing and contamination control.
• Comprehensive knowledge of data integrity principles (ALCOA+) and practical experience embedding these principles into systems and processes.
• Hands-on experience with risk management methodologies applied to pharmaceutical quality and compliance.
• Technical proficiency in process validation, cleaning validation, and computer system validation (CSV).
• Experience with equipment qualification, HVAC systems, and pharmaceutical water systems in a GMP environment.
• Solid understanding of laboratory compliance, analytical method validation, and QC/Microbiology operations.
• Proven ability to manage supplier quality programs, including qualification, audits, and ongoing performance management.
• Bachelor's degree in Pharmacy, Chemistry, Microbiology, Biological Sciences, or a related scientific discipline.
• Strong problem-solving skills with the ability to make sound, risk-based decisions in complex and fast-paced environments.
• Demonstrated ability to build and lead high-performing teams while driving a culture of quality, compliance, and operational excellence.

Additional Skills & Qualifications

• Advanced degree (Master's or equivalent) in a relevant scientific discipline is preferred.
• Experience establishing and monitoring quality-related KPIs such as inspection outcomes, CAPA effectiveness, deviation closure timelines, batch release cycle times, and training compliance rates.
• Familiarity with contamination control strategies and cleanroom operations in sterile pharmaceutical manufacturing.
• Experience leading cross-functional initiatives involving Manufacturing, Engineering, Supply Chain, Warehouse, Validation, and Regulatory Affairs.
• Strong communication and influencing skills, with the ability to represent Quality in executive discussions and business-critical projects.
• Proven track record of implementing continuous improvement initiatives within quality systems and laboratory environments.
• Experience developing succession plans and structured GMP, technical, and leadership training programs.
• Ability to manage complex audit and inspection activities, including customer and third-party audits, with a focus on audit readiness and data integrity.

Work Environment

This role operates within a cGMP-compliant sterile pharmaceutical manufacturing environment that includes clean rooms and controlled areas. The Head of Quality works closely with shop-floor operations, laboratories, and engineering and validation teams to ensure compliance and inspection readiness. The environment emphasizes strict adherence to written procedures, aseptic techniques, contamination control practices, and data integrity standards. Work may involve regular presence in manufacturing and laboratory areas, collaboration with cross-functional teams, and participation in audits and inspections. Professional attire appropriate for an executive leadership role is expected, with additional gowning and personal protective equipment required when entering clean rooms and other controlled environments in accordance with site protocols.

Job Type & Location

This is a Permanent position based out of Boca Raton, FL.

Pay and Benefits

The pay range for this position is $150000.00 - $180000.00/yr. 401k benefits pto growing company

Workplace Type

This is a fully onsite position in Boca Raton,FL.

Application Deadline

This position is anticipated to close on Aug 11, 2026.