The Sr. Associate Quality provides compliance and quality support for applicable GxP processes within the Quality Management System (QMS). The candidate has responsibilities supporting the following areas: (1) Internal audit program and inspection readiness; (2) External inspection including response management and tracking; (3) Annual Product Reports for commercial products; (4) Product disposition; (5) Product Complaint Investigations and (6) Metrics compilation and reporting.
Maintain compliance requirements for established QMS processes and procedures
Provide support to product disposition process by reviewing batch related documentation and verifying GxP and Bioverativ requirements are met
Train and maintain proficiency in using electronic quality systems for managing change control, deviations, CAPA, etc.
Complete analysis, identify issues and provide recommendations for compliance improvements; if applicable, help remediate processes and systems in accordance with company standards and regulatory requirements
Participate on projects or assignments and ensure objectives are appropriately set and met
Demonstrate understanding of and ability to interpret US and international GxP regulations
Interact and coordinate with internal and/or external stakeholders
Bachelor's degree and
2+ years of experience within the Biotech/Pharmaceutical industry in a Quality Management or Compliance role.
4+ years of experience within the Biotech/Pharmaceutical industry
Works effectively and cooperatively with others - Establishes and maintains good working relationships
Attention to detail, strong verbal and written communications, effective time management, and organizational skills
Ability to multi-task and work in a fast paced and dynamic environment
Driven with a strong focus on goals
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.
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.
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