Compliance Specialist Principal

Job Title: Compliance Specialist Principal

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

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.

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 and raw material disposition.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities

• Performing finished product disposition in accordance with Sanofi SOP's, approved product specifications and market regulations

• Reviewing and approving validation protocols and change controls

• Authoring, revising and reviewing SOP's through GEODE system

• Utilizing SAP(Comet), CatsWeb, TrackWise and Phenix to perform

• QA review/approval of deviations and associated CAPAs, and product complaints

• Performing compliance walkthroughs and statistical analysis of results to process or equipment compliance to FDA and GMP requirements Interpreting complex, explicit documentation for new and current procedures and FDA enforcement actions/trends

• Completing analysis, identifying issues and providing recommendations for compliance improvements

• Completing Product complaints in Catsweb, Comet (SAP)

• Participate in audit readiness Support Product launches

• Responsible for QA project management

• Development and training of new staff as needed

• Participate in specialized projects both within Quality and cross-functionally

• Perform 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 lots

• Support additional areas of Quality Disposition including Rejected, Quality Hold and NonConforming Materials Support and when needed lead the Maintenance of Material Master Data in ERP system

• Effectively demonstrates an understanding of GMPs & how it applies to specific responsibilities.

• Following accurate oral & written procedures in performing QA tasks

• Staying up-to-date on training of all procedures

• Routinely and safely handle high value product vials in various stages of packaging completion

• Monitoring operations to ensure compliance with process specifications

• Adhering to Sanofi's safety procedures and guidelines

• Participate in the QA consistency meetings to drive continuous improvement efforts

• Participate in internal audits

• Participate and/or lead in QA audit readiness program as well as assist and participate in external audits and regulatory inspections

• Participate in QA audit readiness program as well as assist and participate in external audits and regulatory inspections

• Participate or may lead in Lean initiatives to improve Quality processes

• Effectively interact on a cross-functional basis providing QA guidance at the area level and escalate any issues to Management in a timely fashion

• May act as a change owner for QA change controls

• May act as the change owner for QA document changes

• Ensure 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.

About You

Basic Qualifications:

• Master's Degree & 4 years of experience, Bachelor’s Degree and 6 years of experience, associate degree and 8 years of experience, or a High School Diploma and 10 years of experience in a Quality and /or other CGMP related fields.

• Experience in a cGMP \Manufacturing Environment or equivalent Knowledge of cGMP regulations for US, EU, and other markets

• Experience with using operational excellence tools to drive continuous improvement Strong technical writing skills

• Strong computer, verbal, and written communication skills

• Experience training and mentoring colleagues

• Ability to prioritize and successfully manage multiple competing activities.

Preferred Qualifications:

• Bachelor's degree with 8-10 years Quality and/or Operations experience in a CGMP Manufacturing Environment or equivalent Industry bio-pharmaceutical experience

• Quality subject matter expert

• Led project teams

• Led development and training and staff Performed all aspects of the deviation/investigation’s workflow

• Clear communicator: strong verbal, written and technical writing skills

• Effective time management, detail-oriented, organizational skills, teamwork and collaboration

• Trackwise or Phenix system experienced

• Experience with Management Inventory system

• Experience with Quality database system, e.g., Comet and Catsweb.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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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