Supply Chain Quality Specialist (CAPA)

Join AbbVie as a Supply Chain Quality 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.

Job Description

AbbVie is dedicated to improving healthcare by providing high quality, safe, effective products and ensuring compliance. This is achieved through a commitment to quality and the continuing effectiveness of the AbbVie Quality System to meet customer and regulatory requirements.

The Supply Chain Quality Assurance (SCQA) Specialist ensures our services meet the established quality standards of the AbbVie Quality System, to assure the right products are delivered to the right customer, at the right time and under the right conditions. The SCQA Specialist proposes measures and improvements to enhance our Supply Chain Quality processes, systems and tools. The SCQA Specialist is a member of the Global SCQA organization and provides support to various stakeholders within the Supply Chain network.

Within this responsibility, the SCQA Specialist has an important role supporting distribution, and logistics activities in Operations and AbbVie’s Quality System, to assure the logistics activities are carried out to continuously meet the requirements of the applicable regulations on Good Distribution Practice (GDP), Good Manufacturing Practice (GMP), ISO 13485 and/or regional/country regulations, for:

• Medicinal Products for Human / Veterinary use
• Active Substances for Medicinal Products for Human / Veterinary use
• Medical Devices
• Cosmetics

• Specific areas of support may include Storage and Distribution Complaints, Product Complaints, Product Quality Plans, Agency inspections/internal audits, CAPA, and overall Quality System requirements.

Responsibilities:

The SCQA Specialist main responsibilities include:

• Coordinate and execute against our ER’s / Non-Conformities / Deviations / Complaints framework for Supply Chain Quality, including oversight and coordination across various SCQA functions. Execute and monitor the timely completion of action plans through our CAPA framework, to drive continuous improvements of our products, distribution network and our quality system. This includes oversight and coordination across various SCQA functions and relevant stakeholders.
• Provides input, coordinate and/or supports the establishment of new documents and updates to existing documents of AbbVie’s Quality System, in support of the SCQA organization.
• Leads or supports self-inspections and/or support internal audits in accordance with the documented audit schedules. Monitors, coordinates and/or executes in support of response to observations, assuring the completion of action plans through our CAPA framework.
• Support external quality inspections and audits. Monitors, coordinates and/or executes response to assigned observations and monitoring the completion of associated action plans through our CAPA framework.
• Identify opportunities for Key Performance Indicators (KPI) and Process Indicator (PI) improvements and coordinate the implementation of these changes. Identify root cause trends across the KPI and PI framework and address opportunities for improvement and report to SCQA management.

Other responsibilities might include:

• Support Change Control framework for Supply Chain Quality. Execute and/or monitor the timely completion of documented actions.
• Support the Training framework for the SCQA and relevant stakeholder organizations.
• Assuring timely implementation of activities, to support business expansion and/or network optimizations associated to new product introductions and/or EU MDR Set Up.

Qualifications

• Bachelor’s Degree in Supply Chain, Logistics, Medical, Scientific, Life Science, Engineering or equivalent fields preferred
• At least 3 years of experience in Quality systems and Quality Assurance in an operational setting, with demonstrated knowledge of techniques for assessing the quality of processes and the ability to guide others in these activities.
• Knowledge of regulations, guidelines and standards related to manufacturing and distribution of medicinal products, medical devices & cosmetics.
• Strong commitment to compliance with the relevant rules and procedures, and to quality and data integrity.
• Previous experience with GMP/GDP quality systems
• Previous ER, CAPA and document systems experience is required (examples: OneVault, OneTrack, etc)
• Strong oral proficiency and mastering technical writing skills in English
• A proactive problem-solving mindset with the ability to embrace challenges as opportunities, breaking down problems into manageable steps, seeking diverse perspectives and prioritize continuous learning and improvement.
• Experienced working in both team settings and independently. Works well with manager guidance to complete operational objectives while able to manage own time effectively.
• Ability to cultivate and maintain strong relationships with key stakeholders.

Additional Information

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.