COMPLETE Compliance Principal, Quality Assurance - Ridgefield, NJ

The Compliance Principal will be responsible for tracking the status of product deviations, leading root cause analysis activities, approving deviation reports and providing technical support to Operations. In addition, this role will be responsible for creation, review and approval of CAPAs and Effectiveness Checks.

RESPONSIBILITIES:

• Collaborate with Quality, Subject Matter Experts (SMEs) and Manufacturing as required

• Leading and authoring complex technical investigations with investigation team to ensure regulatory compliance

• Provide Quality technical expertise to assist manufacturing investigations associated with OOS/OOTs, Utility Interruptions and Environmental Monitoring excursions

• Develop investigation strategy and complete within required timeline

• Proficient in Root Cause Analysis Techniques

• Perform detailed analysis of data, trends and systems

• Determine scope and criticality of the investigations, and perform review and approval of deviations

• Support investigations of minor non-conformances

• Present investigations to Management Review Board (MRB)

• Creation and approval of CAPAs to prevent recurrence of deviations

• Provide guidance and training to personnel performing deviation and CAPA activities

• Authoring and updating SOPs to maintain compliance to corporate standards, and cGMP requirements

• Trending of deviation and CAPA reports, and recommendations per results

• Perform basic statistical analysis

• Support internal and external audits and inspections

EDUCATION / EXPERIENCE:

• Bachelor’s Degree with 5 or more years’ experience, or Master’s degree with 3 years or more years related experience in Quality Assurance / GMP environment

• Working knowledge of cGMPs in pharmaceuticals/biological and aseptic manufacturing

• Excellent technical writing skills

• Leading Investigation Team

• Strong analytical and problem-solving skills

• Make sound judgement from data

• Basic knowledge of Statistics and Trending

• Preferred experience with Lean, 5S and Gemba

• Strong communicator

• Works independently to ensure on-time investigation closure

• Working knowledge of Word, Excel, PowerPoint

• Preferred experience with a deviation/CAPA enterprise system (Trackwise, SAP, Phenix system, Veeva Vault etc.)

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.