Manager, Design Quality - Lifecycle Management

Role Summary

Manager, Design Quality - Lifecycle Management. 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.

Responsibilities

• 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 AbbVie.
• Lead/support process validation activities (IQ/OQ/PQ/PPQ), including TMV.
• Mentor/lead product team members through the design transfer process providing guidance to assure optimal approach.
• Lead/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 team for impact assessments, define and execute action plans, and monitor to ensure timely closure.
• Ensure design control documentation (Traceability/Linkages) & design change control requirements are met.
• Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure.
• Assist 3rd party suppliers during change management process, including change management strategies
• Identify gaps in existing processes as well as 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 SME.
• Participates in the development of global Product Quality Assurance strategy to support device and combination products produced at AbbVie plants as well as contract manufacturing and supplier facilities. Implements agreed strategy.
• Makes recommendations for key decisions on product quality, compliance and regulatory conformance issues
• Establishes and maintains relationships and open communication with suppliers, contract manufacturers, AbbVie 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.
• Initiate assignments independently. Actively lead and participate on development and process improvement teams. Anticipate/resolve quality issues and take preventative actions.
• Actively monitor effectiveness of processes and quality of project work, propose and execute quality/process improvements. Write/review policies/processes/procedures and related documents
• Conduct, lead, or participate in investigations and review boards for Change Plans, CAPAs, NCRs, Observations, etc.

Qualifications

• Bachelor‚Äôs Degree in relevant Life Science or other technical discipline or equivalent job experience required.
• 7+ years of total combined experience. At least 5 years in Quality Assurance Operations Management; 3 years in Operations, Research and Development or Consulting.
• Knowledge and a comprehensive understanding of some biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid tablets and caplets, suspensions, granulations, soft elastic capsules, gel caps, extended release products, coating solutions, and/or active pharmaceutical ingredients).
• Possesses knowledge and a skill set to operate within an environment that requires a high degree of urgency, strong analytical and problem solving skills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as leaders, members and individuals.
• Working knowledge of ISO 13485, ISO 14971, 21 CFR 4, 21 CFR 820, EU Regulation 93/42/EEC (MDD) & 2017/745 (MDR)
• Able to travel up to 10% of the time.