Director, Quality, Aptar Pharma North America
Aptar Italia S.P.A., Congers, NY, United States
Primary Purpose Summary
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.
Primary Duties and 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.
Required Qualifications
Education: BS in Biology, Chemistry, Pharmacy or engineering disciplines; Graduate degree preferred
Experience: minimum of 15 years in Quality, Operations, R&D. Medical device or pharmaceutical industry with strong working knowledge of quality assurance.
Skills: 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.
Benefits
An exciting, inclusive and value based working environment
Award-winning corporate university offering personal development and training opportunities.
Competitive base salary and performance-based bonus plan.
Contribute to the communities where we reside.
Compensation and Base Annual Pay Aptar Pharma offers a competitive total rewards package including base salary or base hourly rate determined by many factors including the role, experience, knowledge, skill set and location. For those in eligible roles, discretionary incentive compensation which may be awarded in recognition of individual achievements and contributions.
The typical base annual salary range for the position of Director of Quality to the specific work location of: Congers, NY region is USD $206,000 to $279,000 per year. Additional details about total compensation and benefits are provided during the hiring process.
Aptar is an equal opportunities employer. We believe that a diverse workforce is key to our success. We welcome applications from all members of society irrespective of age, sex, disability, sexual orientation, race, religion or belief.
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Primary Duties and 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.
Required Qualifications
Education: BS in Biology, Chemistry, Pharmacy or engineering disciplines; Graduate degree preferred
Experience: minimum of 15 years in Quality, Operations, R&D. Medical device or pharmaceutical industry with strong working knowledge of quality assurance.
Skills: 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.
Benefits
An exciting, inclusive and value based working environment
Award-winning corporate university offering personal development and training opportunities.
Competitive base salary and performance-based bonus plan.
Contribute to the communities where we reside.
Compensation and Base Annual Pay Aptar Pharma offers a competitive total rewards package including base salary or base hourly rate determined by many factors including the role, experience, knowledge, skill set and location. For those in eligible roles, discretionary incentive compensation which may be awarded in recognition of individual achievements and contributions.
The typical base annual salary range for the position of Director of Quality to the specific work location of: Congers, NY region is USD $206,000 to $279,000 per year. Additional details about total compensation and benefits are provided during the hiring process.
Aptar is an equal opportunities employer. We believe that a diverse workforce is key to our success. We welcome applications from all members of society irrespective of age, sex, disability, sexual orientation, race, religion or belief.
#J-18808-Ljbffr