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:

• Commercial combination products, including auto-injectors.

• Device Development, New Product Development teams that design and develop devices and combination products for global markets.

• 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.

• Assure all assigned activities are in compliance with Client Design Control Procedures and the Quality System Regulation

• Ensure risk management is executed through Risk Management Plans, Hazard analyses, and risk analyses, eg. dFMEA, pFMEA, uFMEA etc

• Determines disposition of products according to Client and regulatory specifications and standards

• Reviews Annual Product Quality Reviews (APQRs) authored by Contract Manufacturers /Packagers and supplement APQR as required

• 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

• Supports investigations and serves as technical quality SME for quality events related to device combination product

• Support evaluation of changes (component, product, process) prior to and post design transfer for impact on manufacturing process, documentation and design control elements

• Authors and reviews Device/Combination Product Quality Agreements

• Approve product quality complaint investigations

• Review and approve validation/qualification protocols and reports from the External Manufacturer

• Serve on Fact Finding Investigation Review Meetings

• Supports product recalls and executes plan as assigned

• Represent Quality on cross-functional teams within the "Virtual Manufacturing Plant", Technical Transfer teams, Supplier Selection, Serialization, Manufacturing, Packaging launch teams

• 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

+ 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).

+ Proven knowledge in the use and implementation of device standards (ISO 11040, ISO 11608) and packaging standards (ISTA 3A, 7D, ASTM D4169).

+ Experience/knowledge of device and packaging design, statistics and design of experiments.

+ Awareness of pharmaceutical and biologic regulations and standards including 21 CFR Part 210, 211, 600, and relevant ICH guidelines.

+ Experience in implementing RFID and UDI packaging solutions and corresponding regulatory requirements for technologies to track and identify product.

+ Proven experience in CAPA investigation to provide solutions for commercial operations, manufacturing and distribution sites.

+ 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

+ 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.

+ Review and approve packaging design, development and commercialization documentation in accordance with applicable regulatory requirements.

+ Assist or perform risk assessments and analyses.

+ 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.

+ Review and approves change control proposals, deviations, investigations and CAPAs as part of general quality support.

+ Serve as quality SME for products that require thermal protection systems and monitoring.

+ Ensure compliance to cGMPs, GDPs, QSRs and applicable Client policies and standards.

+ 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).
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