Quality Systems Manager
VALLEY COTTAGE, NYJobSeen 3 days agoSeen in employer's feed 3 days ago
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Job overview
The Quality Systems Manager provides strategic and tactical leadership for the Quality Management System at Aptar Congers, maintaining compliance with company policy, applicable ISO standards, and regulatory requirements. The role leads a team responsible for site-wide QMS functions, manages customer and regulatory audit requests, and works with site and global teams to improve quality processes and employee understanding.
Skills & qualifications
Skills
Qualifications
Full job description
Quality Systems Manager Work Location: Congers NY Improving Health through Science and Technology! AtAptar Pharma, we specialize in Drug Delivery offering Innovative Devices, Services and Solutions focused on Patient Experience.Aptar Pharmais part of Aptar Group, a global leader of 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! What You Will Do at Aptar Pharma: The primary mission of theQuality 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 What Aptar Pharma Is Looking For: Primary Duties and Responsibilities:Lead and Deploys the Quality Policy at Aptar CongersBe 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 CongersLead 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 functionsActively 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 IndicatorsLead 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 applicableProvide 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. What you will bring on the journey: Education: *Bachelor's Degree or equivalent work experience in Quality (Medical Device, Biomedical or Pharmaceutical industries).Experience:
How this job compares
Set against the 5,107 open Quality Assurance jobs on Olive Jobs, counted November 1, 2026.
- Pay
- This postingNot listed
- New York median$91–129K/yr158 salary ranges
- New York median$25–29/hr76 hourly ranges
- Openings
- Olive Jobs lists 291 open Quality Assurance jobs in New York and 5,107 across the US. 3% of them nationwide are listed as remote or flexible.
- Hiring the most in New York
- Regeneron Pharmaceuticals20 open
- CDM Smith5 open
- Curia5 open
- Experience
- Quality Assurance postings that state a minimum ask for 5 years of experience at the median; the middle half ask for 2 to 5 years (3,907 postings).
- Education
- 1,757 of the 5,107 open Quality Assurance jobs (34%) ask for a bachelor's degree or higher.
Counted across the open, public US postings on Olive Jobs on November 1, 2026. Pay medians are the middle values of the low ends and of the high ends of postings that list both ends of a range in the same cadence (a yearly salary or an hourly rate); a range's midpoint is halfway between its ends. Pay and experience figures resting on fewer than 20 postings are left out.
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