The Associate Director Quality is part of the Quality Assurance Department at Ridgefield, NJ. This role is responsible for providing direction and managing Teams of Quality Professionals whose objectives are to ensure product testing, release and continued process control and to:

• Provides direct supervision to deviation / CAPA team, Quality Assurance Inspection Team and Supplier Quality Team to meet Sanofi, regulatory agency requirements and business needs

• Provides guidance to internal customers (Quality, manufacturing, operations) to ensure compliance to regulatory and local requirements

• Provides guidance to internal customers (Quality, manufacturing, operations) to ensure compliance

• Collaborate with Subject Matter Experts (SME) and Manufacturing as required; determine the scope of the investigation

• Leading complex technical investigations and investigation team

• Assures incoming materials that are involved in regulatory holds, change controls, or major investigations are not released until appropriate notifications are received. 

• Monitors batch record trends (right first time, first time pass, and backlog) and facilitates actions or investigations as required. Trending of deviation and CAPA reports, and recommendations per results

• Generate deviation and CAPA Metrics monthly

• Generate and report departmental metrics at monthly and annual reviews.

• Reports departmental metrics at monthly and annual reviews

• Supports/participates as required with third party audits

• Prepares responses and reports for third party audit observations as needed

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

• Classification, review and approval of deviations

• Present investigations to Quality Review Board

• Creation and approval of CAPAs to ensure Root Cause is properly addressed

• Provide guidance and training to personnel performing deviation, CAPA, batch record review and product release activities

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

• Support regulatory, third party and internal audits

• Prepare response and reports from audits

• Able to convey complex information in a concise manner

• Ensure team effectiveness and efficiency by setting clear goals and providing timely feedback

• Motivate and Develop team

• Interact with Project Teams and cross-functional groups related to site operations

The Associate Director Quality Compliance is expected to act on and demonstrate the Sanofi LEAD competencies:

• Act for Change: Embrace change and innovation and initiate new and improved ways of working.

• Cooperate transversally: Collaborate effectively with peers, stakeholders and partners across the organization to positively impact business results.

Develop People: Take responsibility for developing one’s self and others in anticipation of future business needs

QUALIFICATIONS

• BA / BS in scientific or related discipline

• Minimum 7-10 years’ experience in specific job-related area

• Experience in managing deviation and CAPA programs

• Working knowledge of cGMPs in pharmaceuticals/biological/aseptic/medical device manufacturing

• Strong background in aseptic operations/ sterile operations

• Experience in Supplier Quality Management

• Excellent technical writing skills

• Ability to collaborate effectively

• Strong analytical and problem solving skills

• Make sound judgement from data

• Preferred experience with Lean, 5S and Gemba

• Strong communicator

• Works independently

• Working knowledge of Word, Excel, PowerPoint, Visio

• Preferred experience with a deviation/CAPA enterprise system (Trackwise, VivaVault SAP, 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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