QA Director

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.

Purpose

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.

Responsibilities

• Establish a Quality Control Strategy for all applicable products and implement appropriate processes and staffing for strategy achievement, which includes the following areas:
  Incoming material inspection and release, lot review and release, final packaging inspection, Donor review process
• 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.
• 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.
• 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
• 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
• Ensures project deadlines and performance standards are established and met
• Ensures the creation of goals and objectives in alignment with the overall strategy

• Bachelor's degree required in Business, Biology, Engineering, or related scientific field from an accredited college or university
• 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.
• Demonstrated knowledge in Quality Systems, Quality Operations practices, and procedures.
• Demonstrated people management skills including leadership, strategic planning, delegation, and follow up along with recruiting, developing, and retaining key talent
• Knowledge of risk analysis tools and statistical methodology
• Ability to gown and enter cleanroom processing environments and work within an office setting

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our short-term incentive programs. ​

• This job is eligible to participate in our long-term incentive programs​

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Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

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