QA Director

AbbVie; Worcester (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

AbbVie is seeking a QA Director to lead the quality control and assurance functions. This role involves strategic leadership in compliance with regulatory standards and fostering a quality culture. The ideal candidate will have extensive experience in Quality/Regulatory within the pharmaceutical industry and a strong educational background. Join AbbVie to make a significant impact on health solutions.

Qualifications

• Minimum of 15 years of relevant experience in Quality/Regulatory.
• Strong knowledge of Quality Systems and Operations practices.
• Ability to work in cleanroom environments.

Responsibilities

• Establish a Quality Control Strategy and implement processes.
• Ensure compliance with FDA regulations and quality management systems.
• Partner with manufacturing to meet product supply goals.

Skills

Leadership

Strategic Planning

Quality Systems Knowledge

Risk Analysis

Education

Bachelor's degree in Business, Biology, Engineering, or related field

Job description

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Company Description

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 TikTok.

Job Description

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, aligned with the organization’s global strategy and the site's goals and objectives. The incumbent oversees functions such as Supplier Controls/Incoming Material Inspection, Incoming Tissue Inspection, Final Product Packaging Inspection, Product Release, Donor Eligibility and Release, Product Change Control, and Facility/Utility/Equipment Qualification.

Responsibilities

1. Establish a Quality Control Strategy for all applicable products and implement processes and staffing to achieve this strategy, including incoming material inspection, lot review and release, final packaging inspection, and donor review process.
2. Lead within the quality organization to ensure quality requirements are met. Act as delegate; Management with Executive Responsibility, Management Representative, or Person Responsible for Regulatory Compliance: ensure product/device conformity per the quality management system before release and document compliance for clinical investigation products.
3. Monitor and implement processes to ensure compliance with regulations such as FDA 21CFR parts 1271, 210, 211, 806, 820, ISO9001, 13485, Canadian regulations, Tissue Banking Standards, and other applicable standards and regulations. Benchmark and leverage industry best practices and partner with key stakeholders.
4. Assess team performance using metrics and implement improvement initiatives. Serve as a role model and leader for all Quality employees.
5. Partner with manufacturing to meet product supply goals while ensuring quality compliance. Participate in market demand forecasting and resource alignment.
6. Ensure project deadlines and performance standards are established and met.
7. Create goals and objectives aligned with the overall strategy.

Qualifications

• Bachelor's degree in Business, Biology, Engineering, or related scientific field from an accredited institution.
• Minimum of 15 years of relevant experience in Quality/Regulatory within pharma, biologics, medical devices, or related regulated industries. Additional experience outside Quality/Regulatory functions is preferred.
• Strong knowledge of Quality Systems, Operations practices, and procedures.
• Proven leadership, strategic planning, delegation, and talent management skills.
• Knowledge of risk analysis tools and statistical methodologies.
• Ability to gown and work in cleanroom environments as well as in office settings.

Additional Information

Details about pay range, benefits, and compliance with pay disclosure laws are included, emphasizing AbbVie's commitment to equal opportunity and accommodations.

Additional Details

• Seniority level: Director
• Employment type: Full-time
• Job function: Quality Assurance