Manager, Product Quality

AbbVie•Barceloneta, PR

About The Position

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. The Manager, Product Quality is responsible for the quality of assigned products, which may include small molecule pharmaceuticals, biologics, combination products, and medical devices. This role ensures business objectives are met regarding on-time delivery of product while maintaining compliance with local, divisional, and corporate policies and external agency regulations worldwide. The scope includes regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates or Drug Products produced by AbbVie plants or third-party manufacturers, In Licensing relationships, or Co-Marketing relationships. The role also develops appropriate regulatory strategies for product brands in conjunction with Regulatory Affairs. The grade is commensurate with the level of overall responsibility.

Requirements

Bachelor’s Degree in relevant Life Science or Engineering is required.
Minimum of 8 years of total combined experience in Quality and Manufacturing.
Experience with Supplier Management.
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, negotiation, and conflict management skills, and the ability to manage multiple complex tasks simultaneously.

Nice To Haves

Knowledge in Biologics (parenteral manufacturing and visual inspection process) is highly desired.

Responsibilities

Performs final quality decisions related to manufactured product lots for products and/or product lines prepared by Third Party Manufacturers and Suppliers.
Maintains the primary quality lead with management oversight for project activities and team members (within and outside of AbbVie) to achieve on-time quality deliverables, high customer value, and profitable results.
Serves as the primary driver for the quality and compliance aspects of product transfers and organization optimization.
Participates in the development of global Product Quality Assurance strategy to support pharmaceuticals, biologics, devices, and combination products produced at AbbVie plants as well as third-party manufacturing (TPM) facilities and implements the agreed strategy.
Makes recommendations for 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 legal contracts and that the commitments of the quality and technical agreements are being fulfilled, facilitating resolution when 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.
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 while balancing the cost of operating to provide AbbVie with the agreed service.
Prioritizes programs, initiatives, and problem-solving with consideration for impact on timelines, resources, and conflicting priorities.
Interfaces with the Quality Assurance audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and responses, and maintain the 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 third-party manufacturers to ensure regulatory approvals are obtained with no delays to market entries.
Contributes to Quality Assurance elements needed to facilitate new product launches, including for Third Party Manufacturers providing products directly to distribution centers or to AbbVie domestic and International plants for further packaging and/or testing.
Coordinates activities to support follow-up on compliant 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 Third Party Manufacturers that identify and address quality, operational, and organizational issues.
Obtains and reviews summaries of the Annual Product Reviews (domestic) and Annual Product Quality Reports (EU) from the Third Party Manufacturer to ensure accuracy, completeness, timeliness, and that trends are identified and addressed appropriately.