Director, Quality, Aptar Pharma North America

Aptar Group • Town of Clarkstown, NY

11d • Onsite

About The Position

Aptar Pharma is seeking a Director of Quality based onsite in Congers, NY. The Director of Quality is accountable for driving total quality and all quality functions of Aptar Pharma North America’s full and complete product line and development lifecycle. This role will lead the Congers Quality department and its related activities covering the three Pharma divisions Prescription (Rx), Consumer Health Care (CHC), and Injectables (INJ). Accountable for the direction of North America Quality function and team who are leading all through daily operations and systems; as well as overall acceptance or rejection of product. Responsible to keep abreast of industry trends, as well as corporate initiatives that drive continuous quality improvement in a lean operating model. Ensures compliance with applicable cGMPs, FDA requirements, product and market related requirements and internal procedures. Approves Annual Product Reviews, is a member of the Change Control Committee, and oversees all Quality Key Performance Indicators (KPI’s) to ensure objectives and customer satisfaction are met. This is an onsite position based in our Congers, NY facility and is also a member of Aptar Congers management committee.

Requirements

• BS in Biology, Chemistry, Pharmacy or engineering disciplines; Graduate degree preferred
• minimum of 15 years in Quality, Operations, R&D. Medical device or pharmaceutical industry with strong working knowledge of quality assurance.
• Multi-discipline expertise and experience in Quality roles and strong leadership skills.
• Excellent working knowledge, understanding and experience with the practical implementation of FDA and EMA regulations and guidelines in other regulatory standards.

Responsibilities

• Lead QC, QA, QS and QE functional areas developing and following strategies and oversight ensuring compliance, quality standards and manufacturing output are met
• Accountable for maintaining the respective ISO certifications( ISO 15378)
• Oversee prioritization of Quality activities to ensure KPI’s & customer satisfaction are met.
• Enable and enhance cross-functional collaboration, participate in company meetings to coordinate functions and operations between departments, including alignment of cross functional objectives
• Lead customer audits, regulatory inspections and administer a robust internal auditing system to ensure compliance with applicable cGMP and FDA requirements
• Lead and develop a large and diverse quality organization with a strong emphasis on digital transformation within quality processes
• Drive compliance via management and maintenance of plans and training
• Employ smart, actionable metrics to track; Ensure Company processes are in compliance with cGMP and FDA guidelines.
• Partner with the divisional global quality leaders to optimize the quality practices and product specific requirements and to leverage best practices employed within the Congers site or other Aptar Pharma sites
• Achieve financial objectives by preparing budgets, scheduling expenditures, analyzing variances, compiling and studying costs and initiating corrective actions.
• Responsible for timely hiring, training, development and support of qualified staff to ensure effective execution of roles and responsibilities.
• Responsible for timely updates of departmental achievements and challenges to management with a focus on operations performance and productivity, staff development, continuous improvement, ensure corrective and preventative actions are in place, key projects support and identification and resolution of obstacles to maintain a highly productive functional group.
• Ensure compliance of product transfers.

Benefits

• Competitive base salary and performance-based bonus plan.
• Award-winning corporate university offering personal development and training opportunities.
• Contribute to the communities where we reside.

What This Job Offers

• Job Type: Full-time
• Career Level: Director