AbbVie Manager, Quality Assurance III in Lake County, Illinois

Manager, Quality Assurance III

USA, Illinois, Lake County

1 additional location

USA, Illinois

Manufacturing & Operations

Requisition #1900166

To provide strategy for Quality staff by managing daily activities with consideration to the LRP. Strong decision making and communication for issue resolution within the Quality System.

Key Responsibilities Includes:

  • Defines strategy for staff to manage daily activities for planning and implementing the LRP

  • Manages direct reports including hiring, setting performance expectations, reviewing performance and developing staff to support the Quality needs of the plant. Evaluates and develops tools to enable staff to continually improve performance and maximize productivity

  • Supports internal and external audits, providing responses and developing improvement plans

  • Provides an active role in implementation of policy and procedure in support of the Quality System for the plant

  • Leads or participates in strategic initiatives to improve the following when possible:-Batch record review and release-VCRs and validation protocols-Lot disposition and/or finished goods and/or commodities-APRs/PQRs-Quality metrics-Track and trend activities-Change management-Risk management-Training-Data integrity

  • Performs in-process testing to support Quality on the manufacturing floor

  • Provides feedback and oversight for complaints, non-conformances and deviations, identifying improvements and responding to trends

  • TPM and TPC Quality management, including exception requests (ERs),change requests (CRs) and QTA

  • Reviews and approves Quality system documents and records

  • Tests commodities and raw materials for product compliance and manages retained samples

Level of position is commensurate upon education and experience of the candidate.

  • 8+ years of direct experience in biopharmaceuticals or related industry

  • 4+ years of managerial experience

  • Demonstrated knowledge of Quality Assurance Operations

  • 8+ years of experience in application of FDA/GMP regulations

  • Strong communication skills, tact and diplomacy

  • Demonstrated effectiveness in multi-disciplinary teams across the organization

  • Ability to represent Quality function effectively with senior management and external parties

  • Direct manufacturing experience is strongly preferred

  • Direct regulatory interface experience is preferred

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Additional Information

  • Travel: Yes, 10 % of the Time

  • Job Type: Experienced

  • Schedule: Full-time