Lead Regulatory Site Officer - Framingham Quality Compliance

Company: Sanofi
Location: Framingham
Posted on: February 20, 2021

Job Description:

The health and safety of our employees and candidates is very important to us. Due to the current situation related to the--Coronavirus (COVID-19), we're leveraging our digital capabilities to ensure we can continue to recruit top talent. As your application progresses, you may be asked to use one of our digital tools to help you through your recruitment journey. If so, one of our--colleagues will explain how these tools will be used throughout the recruitment process and will be on hand to answer any questions you might have. Lead Regulatory Site Officer - Framingham Quality Compliance From Research and Development to Sales and Marketing, Sanofi offers a wide range of possibilities. Discover our open positions and become a health journey partner. Do you have what it takes for a successful career with Sanofi? The department provides leadership, guidance and oversight of the Quality Policy, Dossier Compliance , External inspections, self inspection and Risk Management programs for the Framingham Biologics and Biosurgery site. Lead Maintenance of Dossier Compliance and Maintenance of the compliance of the State-of-the-Art for all site product lines. Leadership and coordination of site external inspection readiness and Regulatory Authority communication. Functions include: facilitation, management and support of all site external regulatory inspections; leadership and coordination of the inspection response; approve and track inspection commitments; approve Regulatory Authority response to inquiry, submissions and notifications. Job overview: Lead project teams to determine the approach for complex maintenance of Dossier Compliance and State-of-the-Art compliance projects. Ensure that changes affecting more than one site are evaluated and approved through the multi-site change control process. Perform gap analysis of technical documents and determine interrelated impacts to process and systems. Ensure completeness and correctness of items such as engineering studies, validation studies, technical reports, engineering drawings and MBRs/SOPs. 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 prioritization as necessary to ensure that only Products meeting all the license requirements are released to market Assist in maintaining regulatory documents such as Site Master Files. Coordinate 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 --Act as liaison with regulatory authorities, supporting new product and variation approvals Help support & maintain regulatory filings Provide regulatory advice (US, EU etc.) and support to the site, facilitating the introduction of new products, process technologies and continuous improvement projects. Provide appropriate resource to the business to meet product release requirements support of all site external regulatory inspections Work independently with little or no supervision and exercises considerable discretion in determining objectives and approaches to significant organizational project s or assignments Demonstrate 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 quality of products and performance of people. Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs. Effective operating in an evolving, complex and dynamic environment, providing clear direction and instruction to teams, and continuously looking internally and externally for best practices and areas for improvement 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. 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. 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: Bachelor's in Science, Pharmacy or a similar discipline with a minimum of 9 years of experience working in a regulated--cGMP environment OR Master's in Science, Pharmacy or a similar discipline with a minimum 6 years of experience working in a regulated cGMP environment At least 3-4 years' experience in a similar role, working with international regulatory authorities, with demonstrated understanding of US and EU regulatory requirements 1-2 years of experience of manufacturing operations Experience working as in release of products to market Demonstrated ability to effectively manage all aspects of regulatory projects Experience participating in international external regulatory health agency inspections Knowledge of regulatory agency enforcement trends Experience with project management Preferred Qualifications: Post Graduate Studies as appropriate to augment Primary Degree Experience is working with biologics, small molecules, and medical devices, liaising with regulatory authorities, and working through Corporate structures highly desirable 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-SG
#LI-GZ-- 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. Join our Talent Network and get Sanofi communications delivered to your inbox. By submitting your information, you acknowledge that you have read our privacy policy and consent to receive email communication from Sanofi.

Keywords: Sanofi, Framingham , Lead Regulatory Site Officer - Framingham Quality Compliance, Other , Framingham, Massachusetts