Senior Documentation Control Specialist - Vaccine
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- Team player
Culture: Play to Win
Health & Wellness
Comprehensive coverage including medical, dental, vision, and health and wellness programs.
Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.
At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.
Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.
"At Sanofi, We are guided by a deep appreciation and understanding of what it means to live with a rare blood disorder, and we learn by listening to the community – patients, caregivers physicians, and other healthcare professionals."Shannon Resetich US Head Rare Diseases & Blood Disorders
"Patients are at the center of all that we do at Sanofi. Our teams are focused on advancing transformational therapies that can address serious unmet needs for people living with rare blood disorders, and expanding global patient access to our medicines."Mouhamed Gueye US Head Medical Rare Blood Disorders
In the race for the future of health– The Sanofi mRNA Center of Excellence (CoE)
At Sanofi, we believe in a world in which no one suffers or dies from vaccine-preventable diseases. And while the pandemic has shaken up our industry, creating new opportunities and risks, we believe the acceleration of innovation with mRNA technology means vaccines for more people faster than before.
That’s why we’re looking for bold, optimistic world-changers to join the team at our mRNA Center of Excellence. We’re investing €400m a year into the new Center, hiring a team of 400 dedicated employees for it and using it as the foundation to implement integrated end-to-end mRNA vaccine capabilities and research with R&D, digital and CMC teams.
Bring your ambition and optimism for the future to Sanofi. Join us
About the Opportunity
The Quality Documentation Senior Specialist is responsible for managing Sanofi’s mRNA CoE (Center of Excellence) Documentation Management System to ensure all Sanofi’s mRNA CoE records and documentation systems are in compliance with US and international regulations, laws and guidelines. The Senior Specialist is accountable for management of Sanofi’s mRNA CoE Document Management System and paper record archival, as well as leading onsite training efforts- while supporting internal and external audits and inspections. This position will report to the Manger of Quality Systems.
General and Task Management
Manage Sanofi’s mRNA CoE GxP Documentation Management System.
Lead the Document Control department in the creation, revision, distribution and maintenance of controlled documentation (i.e. SOPs, Batch Records, Protocols and Reports, etc). As part of this responsibility, the Senior Specialist will identify area’s for improvement with customer interface and will lead efforts in streamlining the process while minimizing end user issues.
Lead the interaction with departments to revise, issue and track controlled documents and records, in a manner to sufficiently meet End User timelines and deliverables. Maintain trackers and logs for the Document Control department and ensure accuracy for each workstream processed.
Ensure grammatical accuracy and adherence to any site template formatting when assisting in revision of documents. As part of this responsibility, the Senior Specialist will mentor junior members of the department and help drive a culture of Quality in our documentation and adherence to its templates.
Lead efforts with Senior Management in establishing and managing a comprehensive internal compliance training program.
Responsible for compilation of metrics as it pertains to each department’s training.
Lead efforts in the continued development of Sanofi’s mRNA CoE employee training program, and work with Senior Management in identification of opportunities for improvement and compliance to its procedures.
Promote a Quality Culture
Support innovation, teamwork and a continuous improvement effort in the level of Quality in Sanofi’s mRNA CoE documentation. Lead the Document Control department by example and coach junior members of staff to be the voice of Quality.
Ensure that Sanofi’s mRNA CoE Quality documentation meets standards expected by US and global regulatory authorities for research, development and ultimately commercial activities.
Ensure products manufactured at CDMOs meet company quality documentation standards. Lead efforts in the archival folder structure for external documentation record keeping and ensure navigation of the sub-folders is user friendly and logical to end users.
Support client and regulatory inspections when necessary.
Lead document archival efforts and manage the document archival process.
Support an eQMS implementation and conversion of current QMS to eQMS in a streamlined process- to include training of new system to end users.
Bachelor’s degree preferred and 7+ years of experience with Good Manufacturing Practice in the pharmaceutical, biologics or medical device industries.
Proven track record of critical thinking, flexibility and innovation- including the ability to manage priorities, track progress of key projects, and provide updates to leadership as required.
Preferred experience in a supervisory role with direct reports.
Preferred experience with outsourced manufacturing and testing operations
Preferred experience in working in compliance with US, EU and ICH GMP requirements. Demonstrated ability to work independently, handle multiple tasks simultaneously, prioritize, negotiate and meet critical timelines.
Excellent oral and written communication skills.
Strong interpersonal skills to effectively communicate with teams, peers, management and external contacts.
Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.
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.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.
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.