Director of Quality

A growing manufacturer of regulated consumer products is seeking a hands-on Director of Quality to lead its Quality organization and support the company's continued growth as a contract manufacturing partner.

The Director of Quality will have broad responsibility across Quality Assurance, Quality Control, quality systems, regulatory compliance, validation, supplier quality and laboratory operations. This individual will also play an important role in supporting customer relationships, new product development, quality agreements and increasingly complex manufacturing programs.

We are looking for a working leader who combines strong technical and regulatory expertise with energy, accountability and a high level of ownership. This individual will work closely with senior leadership, operations, customers and the Quality team and must be equally comfortable setting direction, developing people and getting into the details on the manufacturing floor.

• Lead the Quality organization, including Quality Assurance, Quality Control, quality systems, laboratory operations, validation, supplier quality and regulatory compliance.
• Own and continuously improve the Quality Management System, including CAPA, deviations and nonconformances, change control, complaints, document control, internal audits, training and management review.
• Maintain a strong state of regulatory and customer inspection readiness and lead Quality activities during FDA, customer and third-party audits.
• Ensure compliance with applicable FDA regulations, cGMP requirements, customer quality requirements and other relevant regulatory standards.
• Lead quality investigations, root-cause analysis and corrective actions, ensuring issues are addressed thoroughly, efficiently and with clear accountability.
• Partner closely with manufacturing and operations to improve product quality, right-first-time performance, batch release timelines and overall operational effectiveness.
• Serve as a visible, hands-on leader who regularly engages with employees on the manufacturing floor and works directly with the team to identify problems and drive solutions.
• Build, coach and develop the Quality team while establishing clear expectations, accountability and ownership throughout the organization.
• Serve as a key Quality partner to contract manufacturing customers, supporting customer audits, quality agreements, new product introductions and quality-related escalations.
• Support the successful onboarding and commercialization of new customers, products, formulations and manufacturing programs.
• Oversee supplier qualification and quality performance to ensure raw materials and external partners consistently meet company, customer and regulatory requirements.
• Provide oversight of validation activities, including equipment qualification, process validation, cleaning validation and analytical method validation.
• Establish and monitor meaningful quality metrics, identify trends and proactively address quality, compliance and operational risks.
• Partner directly with senior leadership to communicate Quality performance, priorities and risks and ensure the Quality function effectively supports the company’s operational and growth objectives.

• Bachelor’s degree in Chemistry, Microbiology, Engineering, Pharmaceutical Sciences or a related scientific or technical discipline.
• 8-12+ years of progressive Quality experience within a regulated manufacturing environment.
• Several years of people leadership experience with demonstrated success developing teams, setting expectations and driving accountability.
• Strong working knowledge of FDA regulations, cGMP requirements and Quality Management Systems.
• Demonstrated experience supporting or leading FDA inspections, customer audits and other regulatory interactions.
• Strong experience with core Quality systems, including CAPA, investigations, deviations, change control, complaints, validation and supplier quality.
• Experience with in pharmaceutical, OTC, medical device, consumer healthcare or another highly regulated manufacturing environment.
• Experience with in contract manufacturing, CDMO or another customer-driven regulated manufacturing environment is strongly preferred.
• Experience working directly with customers on quality agreements, audits, new product introductions and quality-related issues is preferred.