Design Quality - Late Stage Development Manager

Company Description

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

Responsible for quality of assigned New Product Introduction (NPI) combination products and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include infusion pumps, enteral and sub-cutaneous tubing, pump carrying accessories, and other drug administration system accessories. Products may be produced by Abb Vie plants or by third-party manufacturers, in licensing relationships, or co-marketing relationships.

Develops the appropriate Regulatory, Quality and Product Development strategies for NPI products in concert with Regulatory Affairs, marketing, Product Development and other cross-functional stakeholders.

• Serves as the primary quality lead for project activities and the team members (within and outside of Abb Vie) to achieve on-time quality deliverables, high customer value, and profitable results. Primary driver for the quality and compliance aspects of product transfers and organization optimization.
• Assure proper integration and support of device regulations, drug regulations and as appropriate, biologics regulations. Responsible for compliance with company policies and procedures.
• Perform design control activities:
  Mentor/lead product team members through the design process providing guidance to assure optimal approach. Work closely with research organization to ensure potential product issues are identified and addressed in the design. Assure robust product vs. customer requirements. Participate in design reviews. Ensure interfaces to drug development where appropriate.
• Ensure design control documentation (Traceability/Linkages) & design change control requirements are met. Assess the impact of a change on the safety, efficacy of the combination product/device. Analyze and justify the impact on cumulative changes.
• Identify gaps in existing processes as well as the need for new processes. Lead cross-functional teams for solution development and implementation
• Guide project development as a team member in global and local product development teams for Combination Products to proactively and appropriately address quality-related issues. Advise internal business partners with regard to medical device/combination product regulations.
• Support the preparation of regulatory inspections and internal audits and represent QA in inspections and audits as SME.
• Participates in the development of global Product Quality Assurance strategy to support device and combination products produced at Abb Vie plants as well as contract manufacturing and supplier facilities. Implements agreed strategy.
• Participates on New Product teams to bring combination products and medical devices through the Design Control process to deliver on-time product launches. Contributes to Quality Assurance elements needed to facilitate new product launches including Third Party Manufacturer’s that provide products directly to distribution centers, or to Abb Vie domestic and international plants for further packaging and/or testing.
• Makes recommendations for key decisions on product quality, compliance and regulatory conformance issues for sterile and unsterile devices and elevates medium and high-risk events to Abb Vie management.
• Ensures alignment of Quality and Technical Agreements with the legal contracts and that the commitments of the quality and technical agreements are being fulfilled. Helps facilitate resolution in cases where they are not.
• Maintains relationships and open communication with suppliers, contract manufacturers, Abb Vie plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at each site and provide guidance on quality concerns.
• Communicates and negotiates with external companies’ quality organization to maintain a consistent level of quality and a level of expectation that will minimize compliance risks but also balance the cost of operating to provide Abb Vie with the agreed service. Prioritizes programs, initiatives, and problem solving with consideration for impact to timelines, resources and conflicting priorities.
• Interfaces with Abb Vie's audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and…