<p>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 - immunology, oncology, neuroscience, and eye care. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.</p> <p>Job Description</p> <p>Purpose</p> <p>The Director of Quality Control , Quality Assurance, Product Release, or Tissue Services is a key member of the quality leadership team and reports directly to the Site Head of Quality. This role is responsible for providing strategic leadership, appropriate staffing, and sustaining a quality culture, in line with the organization's global strategy and the site's goals and objectives. The incumbent is responsible for strategic direction of one or more of the following functions/teams: Supplier Controls/Incoming Material Inspection, Incoming Tissue Inspection, Final Product Packaging Inspection, Product Release, Donor Eligibility and Release, Product Change Control, Facility/Utility/Equipment Qualification.</p> <p>Responsibilities</p> <ul> <li>Establish a Quality Control Strategy for all applicable products and implement appropriate processes and staffing for strategy achievement, which includes the following areas: </li></ul> <p>Incoming material inspection and release, lot review and release, final packaging inspection, Donor review process</p> <ul> <li>Carry out duties as a leader within the quality organization to ensure quality requirements are met. Act as delegate; Management with Executive Responsibility, Management Representative, or Person(s) Responsible for Regulatory Compliance: The conformity of the product/device is checked in accordance with the quality management system before release and compliance of product/device used for clinical investigation is documented. </li><li>Monitor and implement processes to ensure compliance with Regulations and guidelines including, but not limited to, FDA 21CFR1271, 210, 211, 806, and 820, ISO9001 and 13485, Canadian regulations, Tissue Banking Standards, and Global and State regulations, Benchmark and leverage best practices in the industry and with key corporate partners. </li><li>Assess Team performance using metrics and implement improvement initiatives where gaps or trends are identified. Act as a leader and role model to all Quality employees </li><li>Partner with manufacturing to achieve product supply goals while ensuring compliance with quality requirements and applicable regulations. Participate in market demand forecasting and align resources to meet demand </li><li>Ensures project deadlines and performance standards are established and met </li><li>Ensures the creation of goals and objectives in alignment with the overall strategy </li></ul> <p>Qualifications</p> <ul> <li>Bachelor's degree required in Business, Biology, Engineering, or related scientific field from an accredited college or university </li><li>Minimum 15 years of relevant experience in Quality/Regulatory in pharma, biologics, medical device, or relevant regulated industry. Additional experience outside Quality/Regulatory functions desired. </li><li>Demonstrated knowledge in Quality Systems, Quality Operations practices, and procedures. </li><li>Demonstrated people management skills including leadership, strategic planning, delegation, and follow up along with recruiting, developing, and retaining key talent </li><li>Knowledge of risk analysis tools and statistical methodology </li><li>Ability to gown and enter cleanroom processing environments and work within an office setting </li></ul> <p>Additional Information</p> <p>Applicable only to applicants</p>