Purpose

Responsible for quality of assigned combination products and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to AbbVie policies and external regulations worldwide. Oversee all Quality aspects of Duodopa brand and manage key suppliers of customized medical devices.  Products may be manufactured by AbbVie plants, contract manufacturers or suppliers.  Develops the appropriate regulatory strategies for products in concert with Regulatory Affairs.

Responsibilities:

• Serves as the primary quality lead with management oversight for project activities and the team members (internal and external to AbbVie) to achieve on-time quality deliverables, high customer value, and profitable results. Primary driver for the quality and compliance aspects of product transfers.
• Participates in the development of global Product Quality Assurance strategy to support device and combination products produced at AbbVie plants, contract manufacturers and suppliers.  Implements agreed to strategy.
• Participates on New Product teams to bring combination products and medical devices through the Design Control process to deliver on-time product launches.  Contributes to Quality Assurance elements needed to facilitate new product launches.
• Makes recommendations for key decisions on product quality, compliance and regulatory conformance issues for sterile and unsterile devices and elevates medium and high-risk events to AbbVie management.
• Ensures alignment of Quality and Technical Agreements with the legal contracts and that the commitments of the quality and technical agreements are being fulfilled. Facilitates resolution in cases where they are not.
• 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.
• Communicates and negotiates with external companies’ quality and business organizations to establish a high level of quality that will meet customer expectations and 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.
• Participates and leads product quality investigations to identify root cause and implement corrective actions.  Coordinates activities to support follow-up on complaint trend investigations for non-medical and medical (adverse events). Supports the management of exception documents and Corrective and Preventive Actions.
• Completes 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.
• 7+ years of total combined experience.  At least 5 years in Operations Quality Assurance, 3 years in Operations, Research and Development or Consulting.
• 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.

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.