Patient Safety Operations Specialist

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 – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Purpose

Describe the primary goals, objectives or functions or outputs of this position.

Supports AbbVie’s global quality assurance function, suppliers and manufacturing sites for medical devices and combination products by providing in-house support to ensure product meets customer and regulatory requirements. This position supports the analysis and data collection for product or quality system issues intended to support continuous improvement. This position will also be involved in the support of regulatory inspections for medical devices and combination products.
The employee must conduct their work activities in compliance with all AbbVie internal requirements and with all applicable regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements, and objectives.

Responsibilities

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• Quality Operations - Responsible for the processing and maintenance of SOPs for the business segment. Compiles quality data and trends for Quality Management and Product Reviews.
• Quality and Regulatory Compliance - Provides support and management of regulatory inspections and tracking inspectional responses. Training coordinator function responsibilities.
• Quality Systems - Maintains knowledge in both current and emerging GxP requirements and quality trends as they relate to Medical Device and Combination Products worldwide and supports and executes changes to quality standards/policies to ensure conformance.
• Organization Effectiveness and Strategic Direction - T