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 transfer for impact on manufacturing process, documentation and design control elements.
11. Authors and reviews Device/Combination Product Quality Agreements.
12. Approve product quality complaint investigations.
13. Review and approve validation/qualification protocols and reports from the External Manufacturer.
14. Serve on Fact Finding Investigation Review Meetings.
15. Supports product recalls and executes plan as assigned.
16. Represent Quality on cross-functional teams within the "Virtual Manufacturing Plant", Technical Transfer teams, Supplier Selection, Serialization, Manufacturing, Packaging launch teams.
17. Remain current with the changing landscape of regulations in the global device & combination product space as it relates to Health Authority regulations and requirements.

REQUIRED COMPETENCIES:

Knowledge, Skills, and Abilities

1. Strong understanding of the regulatory and compliance requirements for design controls and risk management (21 CFR Part 11, 211, 820, ISO 13485, ISO 14971, ICH Q9, EU MDR, IVDR).
2. Proven knowledge in the use and implementation of device standards (ISO 11040, ISO 11608) and packaging standards (ISTA 3A, 7D, ASTM D4169).
3. Experience/knowledge of device and packaging design, statistics and design of experiments.
4. Awareness of pharmaceutical and biologic regulations and standards including 21 CFR Part 210, 211, 600, and relevant ICH guidelines.
5. Experience in implementing RFID and UDI packaging solutions and corresponding regulatory requirements for technologies to track and identify product.
6. Proven experience in CAPA investigation to provide solutions for commercial operations, manufacturing and distribution sites.
7. Experience in implementing cold chain solutions from production, packing, storage, global transportation, local storage, warehousing and transportation to point of sale/use.

DUTIES AND RESPONSIBILITIES

1. Provide global quality support and oversight across the Client network with respect to device, combination product packaging/labeling and pharmaceutical primary containers, including design, development, commercialization and post-commercialization activities.
2. Review and approve packaging design, development and commercialization documentation in accordance with applicable regulatory requirements.
3. Assist or perform risk assessments and analyses.
4. Assist or perform investigations and serve as technical quality SME for quality events related to the development, manufacture, storage, transport and/or distribution of Client products as it relates to products and packaging.
5. Review and approves change control proposals, deviations, investigations and CAPAs as part of general quality support.
6. Serve as quality SME for products that require thermal protection systems and monitoring.
7. Ensure compliance to cGMPs, GDPs, QSRs and applicable Client policies and standards.
8. Support inspection readiness at all Client network device and packaging operations.

EDUCATION AND EXPERIENCE

B.S. in an Engineering discipline;
an advanced degree preferred;
quality engineering or six-sigma certification preferred.
Minimum of 8 - 10 years relevant work experience, specifically in the regulated healthcare space (pharmaceuticals, biologics, or medical devices).