Manager Records And Systems, Swiftwater, PA - Vaccine

POSITION OVERVIEW

Manager Records & Systems

This position oversees day-to-day activities for the Swiftwater site Quality document management system and Form Control Program.

Key Accountabilities:

• Responsible for oversight and management of the GxP Form Control Program, ensuring compliance with data integrity and regulatory requirements

• Performs systems tasks for all GxP documents within the electronic document management system (EDMS).

• Electronic Document Management System (EDMS) Functional Administrator- Responsible for system access requests, review of system documentation, training, and document creation/revisions.

• Manages quality events for the department (Deviations, CAPA, Change Controls, etc)

• Responsible for performing training in a group setting or individually

• Responsible for compiling monthly periodic review report

• Manages Quality Documentation projects as-needed

Technical Competencies:

• Strong working knowledge of EDMS functionality and troubleshooting

• Experience with Quality systems including: Geode+, Phenix, MS Office

• Meet/exceed project timelines and deliverables

• Excellent organizational, written, interpersonal, leadership, and teamwork abilities

Basic Requirements:

• Bachelor’s Degree and experience with computer systems

• Minimum 5 years of experience in a cGMP controlled/pharmaceutical industry, preferably in a regulated Quality environment.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.