Framingham, MA, 01701, USA
1 day ago
EDMG Manager
**Job Title:** EDMG Manager **Location:** Framingham, MA **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. 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:** The Manager of Engineering Documentation will: + Act as primary Engineering Documentation interface with stakeholders (i.e. Project Management, Validation and Quality) via strong working relationships, ensuringdeliverables that meet CGMP and site quality requirements. + Manage, mentor and develop Engineering Documentation staff. + Develop procedures and manage the periodic review schedule for the Framingham Biologics site for the management of GMP As-Built drawings and Non-GMP Master Drawings. + Establish and maintain a master inventory list of all GMP and Non-GMP Drawings in an editable format as well as a corresponding hard copy utilizing the Sanofi GlobalEngineering Documentation Management System (EDMS). + Manage EDMS, including electronic routing of documents for update, review andapproval. + Ensure that EDMS procedures, documentation and drawings are maintainedaccording to Sanofi Corporate and Regulatory requirements. + Manage CAD Services for Framingham Biologics site. + Oversee management of complete turnover package through project life cycle for all vendor and site engineering documentation. + Interact with site QA to support regulatory and internal CGMP inspections and audits to ensure documents are maintained in an audit-ready state. + Provide oversight to project contractors to ensure Site documentation requirementsand methods are being utilized per procedures.*Key Responsibilities may differ among employees with **About You** **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: + Respecting the laws and operating within the applicable regulations of the places inwhich 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 respectedfor the quality of its people and products. + Acting as role models for our fellow employees by acting responsibly, fairly, andhonestly in our dealings and exercising sound judgment in performing our jobs. **Leading People** + Sanofi’s leaders are effective operating in an evolving, complex and dynamicenvironment, providing clear direction and instruction to direct reports, andcontinuously looking internally and externally for best practices and areas forimprovement. **Delivering to Customers** + Sanofi’s leaders understand patient and customer needs and build relationships asrequired to meet manufacturing goals while continuously improving operations bysetting high standards for the team so they may perform to a level of excellence **Basic Qualifications** + A Bachelor’s Degree in an applicable engineering or life sciences field. + At least 5 years significant experience in engineering project documentation work in a biotech or similar manufacturing arena. + At least 3 years experience managing Engineering documentation systems orequivalent. + A high degree of familiarity with CGMP, GDP and other applicable regulatoryrequirements. + Exceptional communication and problem solving skills with a service oriented attitude. + Must have strong organizational skills and be creative with implementing a structured data management philosophy. + Must be familiar with MS Office Applications, MS Project, AIA CADStandards and server based electronic documentation storage systems. + Proficient with AutoCad and 3D modeling of drawings **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. \#GD-SG \#LI-GZ \#LI-Onsite \#vhd **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! _US and Puerto Rico Residents Only_ Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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. _North America Applicants Only_ The salary range for this position is: $100,500.00 - $145,166.66 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) . Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
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