Job Title: Senior QA Manager

Work Location: Suffolk County, New York

Summary:

Seeking an experienced Senior Quality Assurance Manager to lead quality initiatives, oversee the implementation and maintenance of a Quality Management System, and drive continuous improvement in packaging or pharmaceutical operations.

Responsibilities:

• Lead the development, implementation, and management of a comprehensive Quality Management System (QMS) in alignment with industry standards and site objectives.
• Drive quality and continuous improvement initiatives to enhance operational efficiency and customer satisfaction.
• Oversee all quality efforts to ensure products consistently meet or exceed established standards and expectations.
• Collaborate with cross-functional teams to identify, implement, and optimize quality improvements and cost-effective processes.
• Ensure timely resolution and closure of Corrective and Preventive Action (CAPA) plans and conduct regular audits to assess QMS effectiveness.
• Analyze quality performance data to identify trends, develop actionable insights, and support data-driven decision-making.
• Establish and monitor key performance indicators (KPIs) to track the effectiveness of quality processes and improvement initiatives.
• Supervise and mentor the Quality Department, providing training and fostering a culture of quality, accountability, and continuous improvement.

Qualifications:

• Bachelor's degree in a related field such as Quality Management, Engineering, or Business Administration preferred.
• Minimum of 5 years of experience in quality management within the printing, packaging, or pharmaceutical industries.
• Demonstrated experience implementing and managing QMS, with knowledge of ISO 9001 standards.
• Proven ability to lead teams, manage direct reports, and drive quality improvements and standardization.
• Understanding of pharmaceutical industry regulations, including cGMP, FDA, and international quality standards.
• Strong analytical skills with experience in data analysis and quality management software; QCBD software experience is a plus.
• Excellent communication and interpersonal skills for effective collaboration and leadership.
• Relevant certifications such as Certified Quality Manager (CQM), Certified Quality Auditor (CQA), or Lean Six Sigma are advantageous.

Published Category: Quality & Validation