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Quality Assurance Manager

Company: Aptar Pharma NA
Location: Congers
Posted on: July 31, 2022

Job Description:

QUALITY ASSURANCE MANAGER Customer Quality Medical Device & BiotechnologyCreate, Innovate, Deliver Solutions! This is what you can expect from a career at Aptar Pharma. We have an exciting new opportunity for a Quality Assurance Manager supporting all product divisions of Aptar Pharma North America located at our offices in Congers, New York. Aptar Pharma is 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 enabling the success of our customers through innovative drug delivery devices and services. Be Aptar!What You Will Do At Aptar PharmaThe primary mission of the Quality Assurance Manager to lead, manage and coordinate Customer Quality activities, including overseeing customer on-boarding, Quality Agreements, notifications & Quality communication, customer driven requests, and other related activities as necessary. The Quality Manager Position is a site-based role that oversees the Customer Complaints team and Customer Quality Specialists. Responsible for ensuring the customer complaints process continuously improves KPI performance and supports overall customer satisfaction. Duties include but are not limited to:

  • Oversees Customer Quality process performance (including Complaint Response time, PPM rate, turnaround time for customer requests, projects, and Quality Agreements)
  • Manage the process performance of customer complaints in compliance with customer, regulatory, and Aptar Congers requirements.
  • Serves as a backup to review and approve customer complaints responses.
  • Assess and understand our customer needs and requirements to develop effective quality processes.
  • Devising and reviewing specifications for products or processes. Setting requirements for raw material or intermediate products for suppliers and monitoring their compliance.
  • Educates other stakeholders on customer requirements as related to quality processes
  • Leads customer facing Quality activities related to the role, including complaint crisis management.
  • Writes, reviews, and negotiates Quality Agreements, specifications, and Technical Agreements.
  • Implement cGMP requirements and Continuous Improvements in Quality Operations.
  • Organize required training (internal and external) for staff.
  • Maintain individual skills keeping up to date with the latest quality management concepts.
  • Assign responsibilities, delegate authority, recruit, select, orient and train employees.
  • Maintain Quality performance level by coaching, counseling, disciplining employees, answering grievances, planning, monitoring, and appraising job results. What Aptar Pharma Is Looking For
    • BS degree in a Life Science or equivalent experience with minimum 7 years experience in Quality Leadership.
    • Excellent computer skills utilizing MS Office. SAP & electronic system experience preferred
    • Strong industry knowledge of dispensing business with strong compliance and cGMP skills.
    • Experience with ISO and/or FDA regulated businesses (9001, 15378, 13485, and/or 21CFR Part Strong project management, organizational skills
    • Experience managing issues and projects between internal stakeholders and customers with experience in escalation management and project management focused on closing gaps between company capabilities and customer needs.
    • Experience managing business processes in Quality and/or Operational function(s)
    • Practical experience of managing customer/third party relationships in commercial, global mindset - min 2 years
    • Proven leadership skills, especially in an environment where there is no direct line managerial responsibility - i.e. persuasive
    • Ability to interpret quality standards into normal business practices in manufacturing industry
    • Ability to multi-task/project manage multiple projects and timelines at a time
    • Influential verbal and written communication skills
    • Strong analytical skills
    • Attention to detail / proactive problem solving
    • Ability to travel at least 20%.
    • This is an onsite position 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 BE YOU, BE APTAR!Aptar is an Equal Employment Opportunity (EEO) employer. We believe that a diverse workforce is key to our success. We welcome applications from all members of society irrespective of age, sex, disability, sexual orientation, race, religion or belief 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 https://jobs.aptar.com/job/Congers-Customer-Quality-Manager-NY-10920/786972801/Aptar Pharma, NA250 Route 303 NorthCongers, NY 10920www.aptar.com

Keywords: Aptar Pharma NA, Yonkers , Quality Assurance Manager, Executive , Congers, New York

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