Associate Director, Design Quality - Late Stage Development

Company Description

AbbVie'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 AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Purpose

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 on-body delivery systems, pre-filled syringes, auto-injectors, infusion pumps, enteral and sub-cutaneous tubing, pump carrying accessories, and other drug administration system accessories.  Products may be produced by AbbVie 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. Acts as the primary quality representative and manages a team of product subject matter experts (SMEs).

Responsibilities:

• Lead a team of Quality Professionals responsible for managing Design Control activities for NPI projects and direct cross-functional team members to achieve on-time quality deliverables, high customer value, and profitable results.
• Ensures delivery of all quality elements needed to facilitate new product introductions of combination products and medical devices.
• Develops Global Product Quality Assurance strategy and implements agreed strategy to support the development of NPI projects.
• Makes key decisions on product quality, compliance and regulatory conformance issues for medical devices and combination products and ensures risk-based elevations to AbbVie leadership.
• Leads the collection, verification and improvement of Quality metrics for management review in partnership with senior leadership to develop a clear picture of overall compliance state and linking this to local/global project implementation.
• Leads a team of SMEs and provides an oversight for project activities and the team members (within and outside of AbbVie) to achieve on-time quality deliverables, high customer value, and profitable results. Primary driver for the quality and compliance aspects of NPI projects.
• Participates in the development of global Quality Assurance strategy for NPI projects to support development of device and combination products. Implements agreed strategy.
• 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 AbbVie with the agreed service. Prioritizes programs, initiatives, and problem solving with consideration for impact to timelines, resources and conflicting priorities.
• Interfaces with AbbVie's audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable. Provides support for quality audits, initial site approvals and due diligence activities. Leads and manages pre-approval inspection readiness as related to contract manufacturers to ensure regulatory approvals are obtained, with no delays to market entries.
• Collaborates with internal and external partners in providing feedback on product quality for management reviews with assigned contract manufacturers that identify and address quality, operational, and organizational issues.

Qualifications

Qualifications

• Bachelor's Degree in relevant Engineering, Life Science or other technical discipline or equivalent job experience required. Graduate degree desired.
• 10+ years of total combined experience.  At least 7 years in Operations Quality Assurance, 3 years in Operations, Research and Development or Consulting.
• Leadership of technical professionals and experience in leading global cross-functional teams with results-orientation. Skilled in the initiation, selection, coordination and management of projects and ability to resolve unusually complex technical problems by providing solutions that are highly innovative.
• Knowledge of regulations and standards affecting devices, biologics and pharmaceutical products, ISO standards, US Code of Federal regulations, and the EU regulations.
• Knowledge and a