Job Description

Primary Job Function:

This position is responsible for managing Quality and Compliance related initiatives within the EPD Quality System organization to ensure safe, effective and quality products can be supplied in accordance with regulatory and business requirements.

Core Job Responsibilities:

Creates and maintains data, documentation, and systems to track, monitor, and support the divisional metrics and management review program. Ensures the integrity, accuracy, consistency, and completeness of site and division data in responsibility.
Corresponds with operations sites and business units regarding inquiries and completion of documentation required by company policies and procedures.
Manages the Corporate Audit Database (ABTRAQ), including management and tracking of all External Agency and AQR audit related data contained within the ABTRAQ system.
Producing the highest quality results while operating within the constraints of the business timelines and guidelines.
Uses discretion in escalating unusual product performance issues, collaborates with other functional areas to discuss and resolve.
Interfaces with several multi-functional areas, such as Commercial, Distribution, Contract Operations, etc., to document, review, and resolve performance reporting issues.
Maintain an excellent understanding of actual and future regulatory expectations for EPD products and provide support for transition into the Business Unit as required.
Supports global initiatives and works with the Business Units to coordinate activities and ensure implementation of key business processes.
Develops and implements quality and compliance initiatives.
Participate on QA cross-functional teams as necessary.
Provide support for external regulatory audits and pre-approval inspections.
Provide leadership as a Process Owner of assigned Quality process in line with the EPD Quality System Framework & Governance.
Play significant role or lead EPD Quality SME Network teams to deliver their respective objectives.

Supervisory/Management Responsibilities:

0

Position Accountability/Scope:

Reports to Head EPD Quality Systems.

Minimum Education:

Required: Bachelor Degree in science, business, or technical related field to perform all aspects of the job.

Minimum Experience/Training Required:

5-8 years experience in the pharmaceutical or medical device industry.
Knowledge of relevant quality system regulations and compliance standards.
Strong written and verbal communication skills for timely, sensitive information sharing.
Ability to lead, influence, and collaborate with internal and external stakeholders.
Skilled in analyzing quality data to drive strategic action plans.
Familiar with quality improvement programs, metrics trending, and data analytics.
Proficiency in MS Office suite of tools such as Microsoft Excel, PowerPoint, Visio, Adobe Acrobat.
Strong Leadership, project management and troubleshooting skills to drive resolution of complex issues.
Experience with identifying Quality issues and implementing Corrective and Preventive actions.

Manager - EPD Quality Systems