Quality Assurance Manager
Company: Aptar Pharma NA
Posted on: July 31, 2022
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
- 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
- Serves as a backup to review and approve customer complaints
- 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
- Organize required training (internal and external) for
- 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,
- 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
- 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.
- 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
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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