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, ensuring
deliverables 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 Global
Engineering Documentation Management System (EDMS).
Manage EDMS, including electronic routing of documents for update, review and
approval.
Ensure that EDMS procedures, documentation and drawings are maintained
according 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 requirements
and 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 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 role models for our fellow employees by acting responsibly, fairly, and
honestly in our dealings and exercising sound judgment in performing our jobs.
Leading People
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
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 or
equivalent.
A high degree of familiarity with CGMP, GDP and other applicable regulatory
requirements.
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 CAD
Standards 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.
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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
