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Quality Regulatory Site Officer

Northborough, Massachusetts

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Overview

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Benefits

  • Health & Wellness

    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

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"My family is everything to me. They are proud of the work I do, educating the community and ensuring that no Pompe patient is left behind."

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Responsibilities

Department description

Quality Assurance (QA) is responsible for quality oversight of operations at Sanofi Genzyme Northborugh Operations facility.Northborugh supplies raw materials for biologic manufacturing and is a label/packaging site for Sanofi products.

The main role of QA within the organization is to provide an independent oversight of operations, inclusive of the Label and Packaging areas and Quality Control laboratories, to ensure that CGMPS aremaintained and quality product is manufactured and dispositioned

In order to achieve this QA reviews and approves Batch Records, Deviations, Laboratory Investigations, CAPAs Change Controls Requests, Document Change Requests, effectiveness reviews as well as associated documentation in support of Preventive/Corrective Maintenance, Metrology,Automation Engineering, Validation and dispositions final Drug Product, and provides QA on the floor presence.

Key Responsibilities

To manage regulatory issues locally at site, supporting improved compliance and regulatory awareness.

Evaluate the regulatory impact of proposed changes at the sites

Communicate proposed CMC changes for prioritisation as necessaryto ensure that only Products meeting all the licence requirements are released to market.

Assist in maintaining regulatory documents such as Site Master Files. Co-ordinate preparation of Product Quality Reviews and Annual Reports (US market). To ensure that only Products meeting all appropriate testing and release criteria are released to market.

To act as liaison with regulatory authorities, supporting new product and variation approvals.

Help support & maintain Northborough’s regulatory filings.

Provides regulatory advice (US, EU etc.) and support to the Northborough site, facilitating the introduction of new products, process technologies and continuous improvement projects.

Provides appropriate resource to the business to meet product release requirements

Basic Qualifications

Degree in Science, Pharmacy or related discipline essential.

At least 3-4 years’ experience in a similar role, working with international regulatory authorities, with demonstrated understanding of US an EU regulatory requirements

1-2 years of experience of manufacturing operations

Preferred Qualifications

Experience working as in release of products to market

Experience is working with small molecules, medical devices as well as biologics, liaising with regulatory authorities, and working through Corporate structures highly desirable.

Demonstrated ability to effectively manage all aspects of regulatory projects

Post Graduate Studies as appropriate to augment Primary Degree

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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