Compliance Specialist Senior

Company: Sanofi
Location: Northborough
Posted on: June 25, 2022

Job Description:

DEPARTMENT DESCRIPTION:QA Disposition is responsible for the disposition of raw materials and finished products at Sanofi's Northborough Operations Center, a state-of-the-art multi-product labeling, packaging, and distribution facility. QA Disposition's main function is as follows: 1. Ensure cGMPs and market regulations are adhered to during finished product packaging operations. 2. Ensure all testing and documentation for raw materials and finished product meets criteria per applicable Material Specifications ln support of our main function, our additional areas of responsibility include; issuing and reviewing/approval of production records and related support documents, validation study review/approval, SOP review/approval, finished product inspection, deviation/CAPA review/approval, external department support activities and final disposition of finished product and raw materials for distribution.POSITION OVERVIEW WITH KEY RESPONSIBILITIES:Core Responsibilities:This position is responsible for performing a variety of complex tasks working independently with little to no supervision and in compliance with cGMPs to support Label and Packaging operations, finished goods, and raw material disposition.Responsibilities include: Performing finished product disposition in accordance with Sanofi SOPs, in-house product specifications and market regulationsReviewing and approving validation protocols and change controlsAuthoring, revising and reviewing SOPs through GEODE SystemUtilizing TrackWise and Phenix to complete investigation of deviations, CAPAs, and NCMRs and SCARsSupporting compliance walkthroughsParticipate in internal auditsParticipate in QA audit readiness program as well as assist and participate in external audits and regulatory inspectionsInterpreting complex, explicit documentation for new and current procedures and FDA enforcement actions/trendSCompleting analysis, identifying issues and providing recommendations for compliance improvementsCompleting Quality Events in Catsweb and Comet(SAP)Development and training of new staff as neededParticipate in specialized projects both within Quality and cross-functionallyPerform all aspects of Quality Disposition as it pertains to release activities that will include, but not limited to the disposition of raw materials and final packaging/component lotsSupport additional areas of Quality Disposition including Rejected, Quality Hold and NonConforming Materials Effectively demonstrates an understanding of GMPs & how it applies to specific responsibilitiesMaintaining material master data in ERP system Following accurate oral & written procedures in performing QA tasksStaying up-to-date on training of all proceduresRoutinely and safely handle high value product vials in various stages of packaging completionAdhering to Sanofi's safety procedures and guidelinesParticipate in Lean initiatives to improve Quality processesParticipate in the QA consistency meetings to support continuous improvement effortsSupport the QA on the floor initiatives which includes; attending daily capacity management and QDCI meetings and assisting customers with resolution of issues in real timeEffectively interact on a cross functional basis providing QA support at the area level and escalate any issues to Management in a timely fashionEnsure that department goals are achieved and on time Quality product is realized through execution of primary role in area of oversight (Batch Record Review, Deviation Management and/or Lot Disposition, etc.)Comply with the requirements of Sanofi's health and safety program.Leadership Qualifications:An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and proceduresBeing honest and treating people with respect and courtesy.Constantly striving to make Sanofi a great place to work, and a company respected for the quality of its people and products.Acting as a role model for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.Leading PeopleSanofi's leaders motivate, inspire, build and retain highly effective manufacturing teams while managing for high performance and developing others. They are learners and courageous decision-makers.Leading the BusinessSanofi's leaders are effectively operating in an evolving, complex and dynamic environment, providing clear direction and instruction to direct reports, and continuously looking internally and externally for best practices and areas for improvement.Delivering to CustomersSanofi's leaders understand patient and customer needs and builds relationships as required to meet manufacturing goals while continuously improving operations by setting high standards for the team so they may perform to a level of excellence.BASIC QUALIFICATIONS:Bachelor's Degree and 4 years of related experience, High School Diploma and 8 years of related experience in Quality and /or other CGMP related fields.Knowledge of cGMP regulations for US, EU, and other marketsExperience with cGMP documentation reviewExperience training colleaguesAbility to prioritize and successfully manage multiple competing activitiesPREFERRED QUALIFICATIONS:Bachelor's degree with 6 years of experience in a Quality and/or cGMP environment.Industry bio-pharmaceutical experienceClear communicatorStrong technical writing skillsStrong computer, verbal, and written communication skillsPerformed deviation/investigations workflowEffective time management, detail-oriented, organizational skills, teamwork, and collaborationTrackwise and/or Phenix system experiencedExperience with Management Inventory systemExperience with Quality database systems, e.g. GEODE, and Comet and CatswebSPECIAL WORKING CONDITIONS:Ability to gown and gain entry to manufacturing areasMust be able to lift 50 lbs.Requires extended time in manufacturing areasAs a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.Fully vaccinated, according to the CDC, an individual is considered to be "fully vaccinated" fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE. 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.GD-SGLI-GZAt 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.PDN-9661194c-6004-4bd8-a538-b9f119e847f2

Keywords: Sanofi, Worcester , Compliance Specialist Senior, Other , Northborough, Massachusetts