Senior Quality Systems Leader - Pharma/Med Devices

Aptar Italia S.P.A.; Congers (NY); On-site; USD 121,000 - 163,000; Full time

Benefits offered by this job

401(k) match

Paid time off

Medical, dental, vision insurance

Life and disability insurance

Job summary

Aptar Pharma in Congers, NY seeks a Quality Systems Manager to provide strategic and tactical QMS leadership, ensuring processes comply with company policy and ISO standards such as ISO 15378 and FDA regulations.

You will lead a team across Document Control, Change Control, CAPA, audits, training, and management reviews, drive improvement, and manage customer interactions and regulatory inspections.

Qualifications

• 5 years’ experience in Quality in ISO certified and/or FDA regulated manufacturing business.
• Experience with ISO 15378 and/or ISO 13485; cGMP and 21 CFR Regulations.
• Experience leading an audit program, customer interaction, managing projects.

Responsibilities

• Lead and deploy the Quality Policy at Aptar Congers.
• Be responsible and accountable for the compliance of the Quality Management System at Aptar Congers on relevant regulations (cGMP, ISO, FDA).
• Verify, maintain and improve the Quality Management System at Aptar Congers.
• Lead and develop a team of specialists covering the site-wide QMS functions: Document Management, Change Control, CAPA, Process Review, Interested Parties, Training, Internal audits, Customer Audits, External audits, Management Review, Annual Product Review and others.
• Manage and independently drive completion for action plans associated to the QMS functions.
• Actively monitor site-wide processes for compliance with internal Procedures and relevant regulations (cGMP, ISO, FDA).
• Manage the performance of the Quality Systems processes through Key Process Indicators.
• Lead and manage requests from customers (preparation of questionnaires, review and negotiations of Quality Agreements).
• Lead and manage the preparation of regulatory inspections/external audits as well as hosting those inspections and audits.
• Maintain the Quality Management System up to date with all relevant Quality Compliance Directives, ISO standards and Regulatory Standards as they evolve and/or become applicable.
• Provide guidance to multiple site functions to ensure they remain in compliance with the Quality System requirements.
• Communicate concisely and make recommendations to senior management regarding risks and opportunities, continuous improvement, corrective actions and preventative actions for quality systems and process improvement.
• Collaborate with Global Quality Organization and Quality operational excellence on best practices.
• Lead and organize trainings to improve employee understanding of Quality processes; this could be for new or current employees.
• Write and revise SOPs, controlled forms, and related documents to ensure best practices and alignment with current operations.
• Develop Quality Systems team members to optimize performance and personnel morale.

Skills

Analytical skills

Communication skills

Interpersonal skills

Leadership

Detail oriented

Cross-functional teamwork

Education

Bachelor’s Degree in Quality

Job description

Aptar Pharma in Congers, NY seeks a Quality Systems Manager to provide strategic and tactical QMS leadership, ensuring processes comply with company policy and ISO standards such as ISO 15378 and FDA regulations.

You will lead a team across Document Control, Change Control, CAPA, audits, training, and management reviews, drive improvement, and manage customer interactions and regulatory inspections.