Quality Systems Manager

What Aptar Pharma Is Looking For:

Primary Duties and 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[1]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.

·       Bachelor’s Degree or equivalent work experience in Quality (Medical Device, Biomedical or Pharmaceutical industries).

  Experience:

·       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

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

·       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.

·       Travel:   Sometimes