Quality Systems Manager

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

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 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 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:

• 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:

• 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.

What We Offer

• An exciting, diverse and value based working environment.
• Award-winning corporate university offering personal development and training opportunities.
• 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 $120,500.00 to USD $163,000 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.

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

Improving Health through Science and Technology!