Director of Quality Systems

Director of Quality Systems

We’re working with a well-established, leading manufacturer of personal care and household cleaning items that is searching for a Director of Quality Systems. This position provides strategic and operational leadership for all quality systems within the facility, regulated under FDA OTC and cGMP standards. This role ensures that all products meet regulatory, quality, and safety standards through system design, compliance, and effective people management. The Director of Quality Systems will lead the Quality Systems team, Microbiology Lab, and Analytical Lab.

Location: Long Island, NY

Job Responsibilities:

• Design, implement, and improve the Quality Management System aligned with guidelines and standards for OTC-regulated personal care products.
• Own and drive quality elements such as document control, change control, CAPA, training, deviation management, and quality risk management.
• Provide daily leadership to the Quality Systems team, Microbiology Lab, and Analytical Lab, overseeing staff performance, workload management, and interdepartmental collaboration.
• Allocate resources and resolve operational bottlenecks to ensure timely execution of quality-critical tasks including sample testing, batch record review, documentation updates, and training tracking.
• Facilitate team meetings, establish clear priorities, and maintain accountability against quality KPIs and deadlines.
• Support product development by reviewing outputs and acting as a conduit between engineering and manufacturing/operations.
• Oversee all functions of the Microbiology Laboratory, including environmental monitoring, product bioburden testing, water quality testing, and method validations.
• Oversee the Analytical Laboratory operations, ensuring timely and accurate release testing, stability studies, raw material qualification, and troubleshooting.
• Ensure labs are fully cGMP compliant, calibrated, validated, and staffed with qualified personnel; manage investigations for lab-related results.
• Lead preparations for and execution of FDA inspections, customer audits, and third-party certifications; own the CAPA lifecycle for all findings.
• Own the controlled document system, ensuring all SOPs, test methods, forms, and work instructions are current, compliant, and approved.
• Direct investigations for deviations, lab anomalies, non-conformances, and customer complaints.
• Use formal tools (e.g., root cause analysis, 5 Whys, Fishbone, FMEA) to drive timely and effective corrective and preventive actions.
• Lead supplier quality programs including audits, performance monitoring, and qualification processes.
• Develop and grow quality capabilities of the business unit through the development and deployment of shared standards, processes, and best practices.
• Promote a culture of accountability, teamwork, and continuous learning within all quality functions.
• Drive improvement initiatives that enhance system robustness and operational efficiency.

Required Skills/Qualifications:

• Bachelor’s degree in Microbiology, Chemistry, Life Sciences, Engineering, or related discipline required.
• Master’s degree preferred.
• 10 years of progressive experience in Quality Assurance or Quality Systems within FDA-regulated industries.
• 5 years of leadership experience managing quality teams and laboratories in a cGMP-compliant manufacturing environment, ideally within OTC or personal care products.
• Demonstrated expertise managing both Microbiology and Analytical Labs and their interface with manufacturing and product release.
• ASQ CQA, CQE, Six Sigma, or equivalent certifications preferred.
• High-level understanding of FDA OTC regulations, 21 CFR Parts 210/211, ISO 22716, ICH Q7–Q10, and laboratory cGMP compliance.
• Skilled in leading large teams, mentoring staff, setting priorities, and resolving conflicts under tight timelines.
• Strong technical writing, problem-solving, and root cause analysis skills.
• Familiarity with Quality Management Systems and lab data management.
• Effective communicator with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, and Supply Chain.