mRNA Center of Excellence, Document Control Manager - Vaccine
mRNA Center of Excellence, Document Control Manager - Vaccine
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mRNA - Manager, Document Control
Primary location – Waltham, MA
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
Intro about the position
About the Opportunity
The Quality Document Control Manager is responsible for:
Overseeing all employee’s and consultants in the Document Control group within Sanofi ‘s mRNA CoE (Center of Excellence). Establish performance goals and strategic/operational objectives for direct reports based on company and departmental goals. Hire, train, develop and management performance of direct reports.
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.
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.
Lead their team to achieve QMS targets for both the site and business objectives.
This position reports directly to the Associate Director of Document Control and Quality Systems and will participate in the development, implementation and administration of an organizational quality management system and monitor progress against strategic quality-related goals.
Key Responsibility for position
About growing with us for winning with us
General and Task Management
Manage Sanofi‘s mRNA CoE GxP Documentation Management System.
Oversee the Document Control team in coordination and support of the creation, revision, distribution, and maintenance of controlled documentation (e.g., SOPs, Batch Records, Protocols and Reports, etc) for all site wide efforts.
Oversee and manage the work being performed directly with departments to revise, issue, and track controlled documents and records, in a manner to sufficiently meet End User timelines and deliverables.
Responsible to work with department leads in identification of opportunities for improvement and compliance to its procedures.
Build upon existing program and manage a comprehensive internal training regimine for internal SOPs and Policies for all Sanofi mRNA CoE employees. Support and compile applicable metrics as it pertains to each department’s training and communicate to senior leadership. Drive accountability of each employee’s training by ensuring department managers appropriately assign SOPs based on tasks performed. Lead efforts with Senior Management in establishing and managing a comprehensive internal compliance training program.
Support senior leadership in the integration and subsequent roll-out efforts with Sanofi’s electronic documentation management system- such as Veeva. Improve and manage the company-wide training program which rolled out to all employees, for use of the new electronic systems. Manage all data migration activities from one Sanofi’s electronic system to another.
Lead a culture of Quality to ensure grammatical accuracy and adherence to any site template formatting for all direct reports involved in the revision of any GxP document. Complete oversight and management of the document archival process.
Promote a Quality Culture
Support innovation, teamwork and a continuous improvement effort in the level of Quality in Sanofi‘s mRNA CoE documentation.
Ensure that Sanofi‘s mRNA CoE Quality documentation meets standards expected by US and global regulatory authorities for research, development and ultimately commercial activities.
Support client and regulatory inspections as necessary.
Motivate and coach the Document Control team to operational success- both in terms of quality delivery and customer satisfaction.
Mentor all direct reports in professional growth and encourage additional trainings and certifications for career advancement.
Consistently promote high standards through personal example and lead the team in a manner that each member understands the standards and behaviors expected of them in relation to Quality.
Competencies / Requirements for position
Must have a Bachelor’s (or post-graduate degree) in a relevant field to the biotech or pharmaceutical industry.
Must have 7+ years of experience within a Quality organization in the pharmaceutical, biologics or medical device industries.
Must have 7+ years of experience in working with Documentation Control Must have 3+ years of experience in a Supervisory or leadership role with multiple direct reports.
Must have experience with continuous improvement of Quality in response to business needs and customer audits/regulatory inspections.
Demonstrated experience in working in compliance with US, EU and ICH GMP requirements and supporting both internal and external audits (from clients and regulatory agencies).
Excellent oral and written communication skills.
Strong interpersonal skills to effectively manage teams, communicate with peers, management and external contacts.
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.
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.