Associate Director, Design Quality - Late Stage Development

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.

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

• 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 comprehensive understanding of medical devices and manufacturing processes.  Experience with root cause investigations, CAPA, statistics and data analytics is a plus.
• 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.
• Strong quality assurance/control, manufacturing, laboratory, technical support, regulatory, and/or validation background is required.
• A wide range of activities are undertaken from long term strategy development to short term crisis management. The incumbent must be capable of understanding and overcoming differing cultural and language obstacles to provide solutions that satisfy Corporate, Divisional, Regional, and Local objectives to effectively manage the action plans that will resolve the issues.

Experience working the requirements for third party external manufacturing.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

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• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our short-term incentive programs. ​

• This job is eligible to participate in our long-term incentive programs​

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Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

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