Quality Systems Manager

Aptar Group•Town of Clarkstown, NY

1d•$120,500 - $163,000•Onsite

About The Position

Improving Health through Science and Technology! At Aptar Pharma, we specialize in Drug Delivery offering Innovative Devices, Services and Solutions focused on Patient Experience. Aptar Pharma is part of Aptar Group, a global leader ofnbsp;dispensing systems for the packaging industry. Aptar Pharma has been setting the standard in drug delivery for decades providing health technology solutions and services enabling effective patient treatment. Be You, Be Aptar! The primary mission of the Quality Systems Manager will provide strategic and tactical Quality Management System (QMS) leadership to ensure system processes remain in compliance with company policy, applicable ISO standards such as ISO15378 and regulatory standards. The Quality Systems Manager will plan, organize and implement strategies and activities regarding QMS elements, such as Document Control, Change Control, Corrective and Preventive Actions (CAPA), Process Review, Interested Parties, Training, Internal audits, Customer Audits, Management review, Annual Product Review and other as required. With the team, the Quality Systems Manager will manage requests from customers such as Audits, Questionnaires, Quality Agreement. Manage day-to-day quality systems processes with team and within cross-functional team, to ensure issues are evaluated and appropriate action plans developed to guarantee and maintain compliance at Aptar Congers

Requirements

Bachelor’s Degree or equivalent work experience in Quality (Medical Device, Biomedical or Pharmaceutical industries).
5 years’ experience in Quality in ISO certified and/or FDA regulated manufacturing business.
Experience with ISO standards ISO 15378 and/or ISO 13485; cGMP and 21 CFR Regulations
Experience leading an audit program, customer interaction, managing projects
Decision making
Strong analytical skills, flexibility, and hands-on.
Strong communication skills: can make oral presentations, facilitate training sessions.
Excellent interpersonal skills, leadership and diplomacy, build strong relationships
Detail oriented, rigorous, analytical, reactive,
Cross functional teamwork.

Nice To Haves

Experience of regulatory inspections in Medical Devices or Pharmaceutical industries is a plus

Responsibilities

Lead and Deploys 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). Analyze QMS process effectiveness and identify any gaps or areas for improvement.
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.