Summary of purpose/major responsibilities:
The Document Systems Manager is:
Responsible for ensuring efficient system for managing all quality documentation (SOPs, Master Batch Records, Protocols, and Reports) are defined, implemented and maintained in accordance with GxPs and applicable Sanofi requirements.
Responsible for ensuring system for managing training program to ensure that personnel are properly trained in cGMPs including implementation of annual training program, quality training, and ongoing refresher training.
This position will be in charge of leading the processes and associated tools when implemented.
- Contribute to definition and continuous improvement of the documentation system (SOPs, Master Batch Records, Protocols, Reports, Site Master File, Quality Manual). Ensure the issuance / update of quality manual site master file and other site registration documentation that may be requested in the frame of the registration of the site. 45%
- Responsible for managing quality documentation archiving, back-up, and retrieval. 10%
- Contribute to the organization and provide support during regulatory inspections or audits. 10%
- Contribute to definition and continuous improvement of the training system (annual program, periodic refresh) and implementation of efficient tools to track the training status/progress of site personnel AND contribute to define and develop training programs 30%
- Responsible for tracking and maintaining training system including database, training documentation, trends and metrics across the organization 5%
- Breadth of responsibility (global/regional/country/site): Pearl River, NY and Meriden, CT Manufacturing Sites
- Financial dimensions: This position does not have budgetary responsibility and purchasing authority.
- This position has no direct reports.
- This position is responsible for oversight of quality systems in documentations.
- Design and Implementation system performance assessment and changes to improve as needed.
- System include the management of preparation, tracking, and implementation of more than 200 SOPs, protocols, and reports each year.
- Also responsible for control of 10-20 Master Manufacturing Instructions per year the management of logbook and ancillary GMP documentation covering 300+ documents (logbooks, forms, contractor records etc.) .
- Responsible for archiving system and primary liaison with SBS (75-100 executed batch records per year, executed protocols, maintenance and engineering records).
- Responsible for maintaining training system including records for 150 individuals per year and other training materials as applicable.
- Bachelor's Degree required, preferably in life sciences.
- A minimum 5-7 years' experience in a cGMP controlled environment (preferably in the pharmaceutical industry), including at least 5 years experience a regulated Quality environment
- Thorough knowledge of cGMPs and regulatory requirements
- Experience interacting with regulatory agencies and health authority inspections
- Excellent organizational, interpersonal and leadership/teamwork abilities are required.
- A strong customer focus and ability to prioritize and adapt to business needs are required.
The individual must interact successfully transversely locally and globally.
Freedom to act, autonomy in decision making.
Context of the job/major challenges
- Must be able to work in a fast paced environment.
- Must be able to make balanced quality decisions.
- Must have the ability to communicate verbally and in written format effectively through multiple layers of the organization.
- Must be highly organized.
- The individual will work independently while driving actions to completion. Some team/project activities may result in more direct oversight.
- Must be able to think strategically.
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.
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