Job Description

Purpose

Responsible for quality of assigned products which may include small molecule pharmaceuticals and/or biologics products, 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 regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates or Drug Products produced by AbbVie plants or by third-party manufacturers, In Licensing relationships, or Co-Marketing relationships. Develops in concert with Regulatory Affairs, the appropriate regulatory strategies for product brands.

Responsibilities

Maintains the primary quality lead with management oversight for project Quality 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, risk management, and compliance aspects of product transfers and organization optimization.

Leads the development of global Product Quality Assurance strategy to support pharmaceuticals, biologics, device and combination products produced at AbbVie plants as well as third party manufacturing (TPM) facilities. Implements agreed strategy.

Makes key decisions on product quality and compliance and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products 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. Helps facilitate resolution in cases where they are not.

Establishes and maintains relationships and open communication with Third Party 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. Primary quality contact with Supply Chain and R&D for new products to be manufactured at TPMs. Acts as a resource for TPMs to evalua

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 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. Provides support for quality audits, initial site approvals and due diligence activities. Leads and manages pre-approval inspection readiness as related to the third party manufacturers to ensure regulatory approvals are obtained, with no delays to market entries.

Manages Quality Assurance elements needed to facilitate new product launches including Third Party Manufacturer’s that provide products directly to distribution centers, or to AbbVie domestic and International plants for further packaging and/or testing. Drives implementation of the Product Transfer Process from R&D to AbbVie sites.

Supports the management of exception documents and Corrective and Preventive Actions. Coordinates input from technical groups (R&D, S&T, Site Tech Ops) to determine root cause and implement appropriate actions.

Develops product quality transfer process monitoring metrics. Manages small teams of quality professionals as required and maintains departmental spend within budget.

Supports the regulatory filings and marketing authorization dossiers by developing and/or reviewing of chemistry, manufacturing and controls documents and Drug Master files/Certificate if suitability of monographs of the Ph. Eur. Documents. Work with AbbVie Affiliates and Regulatory to prepare submissions and participate on emergency response team for all incoming submission deficiencies and questions.