Director of Quality Control

Reports To: VP of Quality / Head of Quality Operations

Will Require 50% Travel - predominantly in North America - also Mexico & Costa Rica

The Director of Quality Control (QC) is responsible for establishing, leading, and continuously improving quality control operations within a manufacturing environment. This role provides strategic and operational leadership for QC laboratories, the Material Review Board (MRB) process, and the Corrective and Preventive Action (CAPA) system, ensuring compliance with applicable regulatory requirements and internal quality standards. The Director of QC partners cross-functionally with Manufacturing, Quality Assurance, Engineering, Supply Chain, and Regulatory Affairs to ensure product quality, process control, and continuous improvement.

Key Responsibilities

• Quality Control & Laboratory Management
• Provide strategic leadership and oversight of all Quality Control laboratory operations, including chemical, physical, and/or microbiological testing as applicable.
• Ensure laboratory activities comply with applicable regulations, standards, and internal procedures (e.g., FDA, ISO, cGMP, GLP).
• Establish and maintain robust test methods, specifications, sampling plans, and laboratory controls.
• Oversee laboratory equipment qualification, calibration, validation, and maintenance programs.
• Ensure timely and accurate release of raw materials, in-process materials, and finished goods.
• Lead laboratory investigations related to out-of-specification (OOS), out-of-trend (OOT), and atypical results.
• Lead or chair the Material Review Board to ensure effective evaluation and disposition of nonconforming materials and products.
• Ensure MRB decisions are data-driven, compliant, and aligned with risk-based quality principles.
• Collaborate with Manufacturing, Engineering, Supply Chain, and Quality Assurance to determine root cause, disposition, and corrective actions.
• Track MRB trends and metrics to drive systemic improvements and prevent recurrence.
• Own and oversee the CAPA system, ensuring timely, effective, and compliant corrective and preventive actions.
• Ensure thorough root cause analysis using structured problem-solving methodologies (e.g., 5 Whys, Fishbone, FMEA).
• Monitor CAPA effectiveness and closure, ensuring sustained improvements.
• Analyze quality data and trends to proactively identify risks and improvement opportunities.
• Drive a culture of continuous improvement and quality excellence across the organization.

Leadership & People Management

• Build, lead, and develop high-performing QC teams, including laboratory scientists, technicians, and supervisors.
• Set clear performance expectations, conduct regular performance reviews, and support employee development.
• Ensure appropriate staffing, training, and succession planning within QC operations.
• Promote a strong quality culture focused on compliance, accountability, and continuous learning.

Compliance, Audits & Metrics

• Support internal, customer, and regulatory audits and inspections related to Quality Control.
• Ensure audit observations related to QC, MRB, and CAPA are addressed effectively and on time.
• Establish and report key quality metrics (KPIs) to senior leadership.
• Ensure data integrity and documentation accuracy across all QC systems.

Education

• Bachelor’s degree in Chemistry, Biology, Engineering, or a related scientific discipline required.
• Advanced degree (Master’s or PhD) preferred.

Experience

• 10+ years of progressive experience in Quality Control within a manufacturing environment.
• 5+ years in a leadership or management role.
• Demonstrated experience managing QC laboratories, MRB processes, and CAPA systems.
• Strong background in regulated manufacturing environments (e.g., FDA, ISO, GMP).
• Deep understanding of quality systems, laboratory operations, and regulatory requirements.
• Proven leadership and people management skills.
• Strong analytical, problem-solving, and decision-making abilities.
• Excellent communication and cross-functional collaboration skills.
• Experience using quality data to drive continuous improvement.