Director, Medical Device

2 weeks ago

North Chicago, Illinois, United States AbbVie Full time
Job Description

Purpose

Responsible for quality oversight for late-stage development and new product introduction of combination products and medical devices. Scope of responsibility can also include business processes supporting new product introduction including risk management.

Builds and maintains relationships with R&D, R&D QA, Regulatory Affairs, E&PQA, S&T, ECM, PSM, and Global Supply Chain to align strategic initiatives.

Develop regulatory strategies for brands with Regulatory Affairs.

Responsibilities


Develop and lead a quality professional team responsible for quality oversight of late-stage development, design transfer, and pre-market readiness activities - conforming to worldwide standards/regulations throughout the NPI supply chain & departmental budget.

Lead team to develop strong relationships with Contract Manufacturers, Suppliers of Customized Products, Suppliers, AbbVie plants, affiliates, & other functional groups.

Help team understand each project's quality, compliance, and organizational resource needs. Align roles and responsibilities across functions.


Ensure delivery of all quality elements needed to facilitate new product launches including partners that provide products directly to distribution centers, or to AbbVie domestic and international plants for further manufacturing, packaging and/or testing.


Core team member representing QA on including Pipeline Teams, New Product Introductions, Governance Process, CMC Leadership Team, Product Transfers, Global Strategic Sourcing, Due Diligence, and Site Selection.

Make primary decisions on product quality, compliance and regulatory conformance issues for device products and elevates medium and high-risk events to AbbVie management.


Develop and implement a global New Product Introduction Quality Assurance strategy to support quality systems or product requirements associated with devices and combination products manufactured at AbbVie plants or at external partner facilities.

Provide a Quality Assurance perspective during new product development and address resolution of quality and compliance issues.


Support development of the legal supply agreements, contracts and letters of intent to ensure the appropriate quality, compliance, and regulatory aspects are met for the products and services covered.

Manage and approve organization's actions—like Quality Technical Agreements— as a representative of AbbVie, within the legal boundaries of these documents.

Reviews and approves negotiated Quality Technical Agreement as a representative of AbbVie.

Key decision maker on product quality, compliance, and regulatory conformance issues for device products. Complete quality reviews with assigned partners that identify and address quality, operational, and organizational issues.

Interface with Quality Assurance audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable.

Provide support for quality audits, initial site approvals and due diligence activities.

Direct and manage pre-approval inspection readiness at external partners to ensure regulatory approvals are obtained, with no delays to market entries.

Actively participates and interfaces directly/indirectly with the FDA, EMA, MHRA, ANVISA, MoH, etc. for pre-approval inspections.


Function as main Quality liaison between external partners and AbbVie Operations in support of commercial operations, new product introductions, and product transfers.

Negotiates with external partners upper management 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.


Establish and maintain relationships and open communication with external partners, AbbVie plants, affiliates and other functional groups (R&D, Regulatory, Purchasing, etc.) to define roles and responsibilities and identify potential projects and issues.

Obtain an in-depth understanding of the quality, compliance, and resource needs at each transfer site. Provide quality oversight and guidance for successful validations (processes, test methods, etc.) and qualifications.


Communicate and negotiate with the external partner's 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.

Prioritize programs, initiatives, and problem solving with consideration for impact to timelines, resources and conflicting priorities.

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