Senior Supplier Quality Assurance Specialist
Summary
Oversee supplier quality for a biotech/pharma manufacturer, resolving nonconformities, managing audits, and ensuring cGMP compliance across a 24/7 production site.
Compliance
- Responsible for medium risk investigations arising from materials nonconformity with cross functional team
- Responsible for medium risk supplier change control with cross functional team
- Manage performance measurements of the Supplier Quality Management business processes
- Accountable for the site approved Supplier Listing is compliance with cGMP requirement
- Accountable for Site Supplier qualification Program
- Responsible for Site CAPA systems and monitoring program
- Ensure timely resolution of site supplier quality issues (such as deviations), audit assessments and subsequent follow-up actions
- Ensure compliance with applicable AbbVie policies, processes and procedures, contributing to the execution of strategies and oversight of Supplier Quality programs
- Ensure timely execution for all supplier related quality activities to the high throughput multi products plants with 24/7 operations while maintaining customer satisfaction service level
- Maintain high levels of Customer satisfaction by positively managing internal and external relationships
- Site’s key representative for global COE forums and responsible for ensuring that information is cascaded timely and accurately to relevant stakeholders by driving actions/communication as required
- Promote and follow safety work practices in the workplace
Operational Excellence - Project/New Product Introduction
- Manage global supplier quality team initiatives or other site improvement projects, e.g., New Product Introduction.
- Manage Global CAPA system improvement initiatives, e.g., One Track implementation.
- Support cross functional projects where necessary
- Minimum 6 years relevant work experience in cGMP Biotechnology/Pharmaceutical manufacturing industry is preferred.
- Knowledge in Supplier Quality Management and regulations is preferred.
- Experience in SAP and TrackWise are preferred
- Effective communicator with experience with internal and external stakeholders is required.
- Good Problem-Solving skills is required
- Highly Motivated, Independent, Organized and Growth mindset.
- Able to be a team player and collaborate with different departments and all levels of the organization
- Agile and able to respond to business urgent requests
- Microsoft office skills
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.
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