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Sanofi Group Manager Compliance in Northborough, Massachusetts

QA Manager is responsible for overseeing label and packaging on the floor operation and disposition of raw materials 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:

  • Ensure cGMP's and market regulations are adhered to during finished product label and packaging operations

  • Ensure all testing and documentation for raw materials 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, QC test results, validation study review/approval, SOP review/approval, change requests, deviation/CAPA review/approval, external department support activities and final disposition of finished product and raw materials for distribution and rejection.

Position Summary:

QA Manager is responsible for leading and developing a team performing a variety of complex tasks in compliance with cGMP's to support packaging operations and raw material disposition. QA Manager works with Sanofi site manufacturing, CMO QA, CMO management, Regulatory Affairs, Quality Control, Material Operations and Planning.

Responsibilities Include:

  • Oversee all quality activities by providing guidance and direction to personnel on work assignments and projects while ensuring compliance with cGMP's to support Northborough operations

  • Ensuring a safe work environment and reporting incidents to site leadership

  • Managing and developing performance by setting clear goals, providing timely feedback, recognizing high performers and holding underperformers accountable

  • Hiring and developing employees by conducting performance appraisals and career development assessments

  • Coordinating the performance of label and packaging of finished product in accordance with Sanofi SOP's, product specifications and market regulations

  • Coordinating the performance of raw material disposition in accordance with Sanofi SOP's, material specifications and market regulations

  • Reviewing and approving validation protocols and change controls

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

  • Utilizing Sanofi Quality Systems (e.g., Phenix) to lead deviation/investigation teams to resolve site deviations, supplier deviations and implement corrective actions

  • 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 improvement

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

  • Lead additional areas of Quality Disposition including Rejected, Quality Hold and Non-Conforming Materials

  • Lead the Maintenance of the Material Master Data in ERP system

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

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

  • Maintaining orderliness of team's work areas

  • Monitoring operations to ensure compliance with process specifications

  • Adhering to Sanofi's safety procedures and guidelines

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 procedures

  • Being 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 judgement in performing our jobs.

Leading People

  • Sanofi’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 Business

  • Sanofi’s leaders are effective 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 Customers

  • Sanofi’s leaders understand patient and customer needs and build 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:

  • Bachelors degree with 10 years Quality and/or Operations experience in a biotech/pharmaceutical cGMP Manufacturing Environment

  • 4-5 years of demonstrated supervisory experience

  • Ability to prioritize and successfully manage multiple competing activities

  • Knowledge of cGMP regulations for US, EU and other markets

  • Experience with cGMP documentation review

Preferred Qualifications:

  • Masters degree with 8 years Quality and/or Operations experience in a biotech/pharmaceutical cGMP Manufacturing Environment

  • Industry bio-pharmaceutical experience

  • Quality subject matter expert

  • Led project teams

  • Led development and training, and staff

  • Performed all aspects of the deviation/investigations workflow

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

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

  • Experience with Management Inventory system

  • Experience with Quality database systems, SAP (Athena, Comet), Catsweb, Phenix, Trackwise

Special Working Conditions:

  • Ability to gown and gain entry to manufacturing areas

  • Must be able to lift 50 lbs

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.

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