Associate Director, Design Quality - Late Stage Development

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.
• 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.
• Bachelor's Degree in relevant Life Science or other technical required. Graduate degree desired. Technical or Analytical background required for problem resolution with technical, quality, product and or engineering related issues.
• 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 prov

Benefits

Additional Information

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).

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at Abbvie? Share your experience