Sr Manager, Quality Assurance

Purpose Statement

Ensure the proper functioning and continuous improvement of the Microbiology, Quality Systems, CAPA, Internal and External Audits, Doc Center, DAL, and DHR departments through effective management of resources and priorities.

Major Responsibilities

• Provide technical direction and support on microbiology applied to the industry.
• Ensure an appropriate microbiological assessment is performed regarding changes that impact the manufacturing process or product.
• Manage the resources and capabilities of each area, as well as coordinate the execution of improvement, cost reduction, and risk reduction projects.
• Provide direction and support in root cause investigations and implementation of corrective and preventive action plans.
• Lead the proper execution and planning of the Internal Audit System in order to comply with requirements established in applicable regulations.
• Provide direction in the preparation and execution of external audits or inspections of the plant Quality System.
• Lead the proper administration of the facility’s Corrective and Preventive Action system.
• Lead the proper functioning of the DHR area (complaint investigations) and the DAL laboratory (returned product analysis), as well as their compliance with applicable standards.
• Lead the proper functioning of the Doc Center area, as well as its compliance with applicable standards.

Education

• Bachelor’s degree in Engineering, Microbiology, Biotechnology, or a related field.
• Certification in Risk Management, Green Belt, CQE, or CMQ-OE (preferred).
• English proficiency C1 (spoken and written).

Experience

• At least 5 years of experience in managerial positions related to Quality Systems.
• At least 5 years of experience managing Microbiology departments in the medical industry (desirable)
• Experience handling and/or participating in external and internal audits.
• At least 2 years of experience managing regulations associated with quality management systems for medical devices, including ISO 13485:2016, FDA, EU MDR, among others.
• Experience in executing continuous improvement projects (preferred)

Abb Vie 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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