Quality Systems Manager (45481)

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 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 best1practices.

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:

Bachelors 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

Skills/Abilities:

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

What We Offer

• An exciting diverse and value based working environment.
• Award-winning corporate university offering personal development and training opportunities.
• Competitive base salary
• Contribute to the communities where we reside.
• Innovative benefits plan which includes 401k plan with Company matching benefit paid time off medical dental vision life disability and more

Compensation and Base Annual Pay
In compliance with pay transparency requirements the salary range for this role isUSD $120500.00 to USD $163000 annually.This is not a guarantee of compensation or salary as final offer amount may vary based on factors including but not limited to experience and geographic location. Aptaralso offers a variety of benefits including health life and disability insurance 401(k) match and employer retirement savings contribution flexible spending accounts EAP education assistance parental leave paid time off company-paid holidays and more. The specific programs and options available to an employee may vary depending on location pay class or other factors.

BE YOU BE APTAR!

Aptar is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race color religion sex sexual orientation gender identity national origin age protected veteran or disabled status or genetic information

Aptar Pharma NA
250 Route 303 North
Congers NY 10920

Improving Health through Science and Technology!

Nearest Major Market:New York City

Apply now

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