Section Manager, Manufacturing Quality Assurance

Company: AbbVie
Location: Worcester
Posted on: January 15, 2020

Job Description:

• Maintains the primary quality lead with management 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 product transfers and organization optimization.
• Participates in the development of global Manufacturing 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.
• Performs final quality release of manufactured product lots for products and/or product lines prepared by AbbVie plants as well as Third Party Manufacturers.
• 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 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, clients, 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 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.
• Provides support for quality audits, initial site approvals and due diligence activities.
• Contributes to Quality Assurance elements needed to facilitate new product launches including Client and Third Party Manufacturer's that provide products to AbbVie domestic and International plants and client fill finish sites for further manufacturing and/or testing. Supports the management of exception documents and Corrective and Preventive Actions.
• Provides information and reviews summaries of the Product Quality Reviews for products manufactured by AbbVie to ensure accuracy, completeness, timeliness, and trends are identified and addressed in an appropriate manner.
• Reviews and provides necessary information for Regulatory filings and validation protocol/reports .
  • Bachelor's Degree in relevant Life Science or other technical discipline or equivalent job experience required.
  • 10+ years of total combined experience within Quality Assurance or Operations. Direct Quality Assurance experience preferred.
  • Knowledge and a comprehensive understanding of some biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid tablets and caplets, suspensions, granulations, soft elastic capsules, gel caps, extended release products, coating solutions, and/or active pharmaceutical ingredients).
  • 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.
  • Knowledge and understanding of process validation for biological technologies.
  • Direct supervisory require d

Keywords: AbbVie, Worcester , Section Manager, Manufacturing Quality Assurance, Executive , Worcester, Massachusetts