Sr. Manager, Packaging and Combination Product Quality

Sr. Quality Manager--Device & Packaging

This role is 100% Onsite
Work Schedule: Monday - Friday, Business Hours

PURPOSE AND SCOPE OF POSITION:

Responsible for providing technical quality and compliance oversight for commercial combination products and support to Device Development and Manufacturing Science & Technology (MS&T). This position is an individual contributor role, providing customer-focused, cross-functional support to the following:

1. Commercial combination products, including auto-injectors.
2. Device Development, New Product Development teams that design and develop devices and combination products for global markets.
3. MS&T Packaging Engineering functions that design, qualify and commercialize combination product packaging, MS&T Packaging and Network sites to ensure appropriate investigations, studies and risk assessments are conducted.
4. Assure all assigned activities are in compliance with Client Design Control Procedures and the Quality System Regulation.
5. Ensure risk management is executed through Risk Management Plans, Hazard analyses, and risk analyses, eg. dFMEA, pFMEA, uFMEA etc.
6. Determines disposition of products according to Client and regulatory specifications and standards.
7. Reviews Annual Product Quality Reviews (APQRs) authored by Contract Manufacturers /Packagers and supplement APQR as required.
8. Investigate and/or evaluate manufacturing, packaging and laboratory deviations or incidents and associated Corrective Actions and/or Preventive Actions (CAPAs). Provide direction and recommendations as to future course(s) of action.
9. Supports investigations and serves as technical quality SME for quality events related to device combination product.
10. Support evaluation of changes (component, product, process) prior to and post design