Manager, Design Quality - Lifecycle Management

About Abb Vie

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 including immunology, oncology and neuroscience, and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit  Follow @abbvie on Linked In, Facebook, Instagram, X and You Tube.

Responsible for representing QA on cross‑functional teams and executing Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on market while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include medical devices and combination products such as consumer eyecare products, ocular implants, pre‑filled syringes, autoinjectors, aesthetic devices, etc.

• Primary driver for the quality and compliance aspects of product transfer and on‑market change management.
• Serves as the primary quality lead for design transfer activities to enable product launch, including transfers both within and outside of Abb Vie.
• Lead or support process validation activities (IQ/OQ/PQ/PPQ), including TMV.
• Mentor and lead product team members through the design transfer process, providing guidance to assure optimal approach.
• Lead or support lifecycle design change projects following Design Control and Change Control principles.
• Own change plans to manage on‑market design changes, collaborate with cross‑functional teams for impact assessments, define and execute action plans, and monitor to ensure timely closure.
• Ensure design control documentation and design change control requirements are met.
• Identify gaps and improvement opportunities within the Design History File and Risk Management and track to closure.
• Assist third‑party suppliers during change management process, including change management strategies.
• Identify gaps in existing processes and the need for new processes; lead cross‑functional teams for solution development and implementation.
• Support the preparation of regulatory inspections and internal audits and represent QA in inspections and audits as subject‑matter expert.
• Participate in the development of global Product Quality Assurance strategy to support device and combination products produced at Abb Vie plants and contract manufacturing & supplier facilities.
• Provide recommendations for key decisions on product quality, compliance and regulatory conformance issues.
• Establish and maintain 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 and resource needs at each site, and provide guidance on quality concerns.
• Initiate assignments independently, actively lead and participate on development and process improvement teams, anticipate and resolve quality issues and take preventative actions.
• Actively monitor effectiveness of processes and quality of project work, propose and execute quality/process improvements, write and review policies/processes/procedures and related documents.
• Conduct, lead or participate in investigations and review boards for change plans, CAPAs, NCRs, observations.

• Bachelor’s degree or equivalent experience in a relevant life science or technical discipline.
• 7+ years of total combined experience including at least 5 years in Quality Assurance Operations Management and 3 years in Operations, R&D or consulting.
• Knowledge of biological and/or pharmaceutical technologies (sterile, liquid, ointments, devices, tablets, granulations, capsules, gel caps, extended‑release products, coating solutions, or active pharmaceutical ingredients).
• Strong analytical and problem‑solving skills with ability to manage multiple complex tasks and work as a leader, member or individual.
• Working knowledge of ISO 13485, ISO 14971, 21 CFR 4, 21 CFR 820, EU Regulation…