Quality System Manager
Bridgewater, New Jersey, Cambridge, Massachusetts
The GRA Quality System manager is reporting to the Quality System Head within the Global Regulatory Quality and Continuous Improvement (Q&CI) Department.
He/she is responsible to establish & maintain a Quality Documentation Management System required by Regulatory Authorities for compliance to GxP and related regulations; Quality Documents (QDs) are subject to inspection by Regulatory Authorities
Duties & Responsibilities:
- Establish and maintain a Quality Documentation Management System for Global Regulatory Affairs (GRA) for all departments worldwide:
- Define and maintain with the GRA Quality System Head the yearly GRA QD plan which is communicated and endorsed by the GRA quality network and the GRA management to ensure collections of needs and priorities;
- Ensure that GRA QDs are appropriately and timely created/updated/cancelled according to the yearly GRA QD plan that reflects business needs, change in the regulation, 3-year QD periodic review, process, integration of sanofi entities, audit or inspection findings etc;
- Provide GRA quality strategy built upon strategic orientations in line with the Company objective towards focus and simplification as described in the Quality Manual (e.g., simplification document architecture)
- Contribute to the development of the Quality Culture in developing and expanding the level of Quality expertise within GRA and be recognized as a key Quality referent within the organization;
- Provide expertise and guidance to ensure key regulatory activities and processes are covered by QDs and implemented in compliance with GxP regulations;
- Provide continuous expertise, support and guidance to the Business Process Leader for the development review and approval of QDs;
- Guarantee the consistency of the GRA quality system;
- Ensure the global glossary is maintained up to date regarding definitions available in GRA QDs;
- Contribute to the production and update of eMaps (in collaboration with MCCQ);
- Manage approval and obsoletion of QDs in the Quality Document Electronic Management System;
- Manage QD properties in the Quality Document Electronic Management System;
- Communicate in a timely manner inside and outside GRA on new, updated and obsoleted QDs;
- Actively participate to monthly GRA Quality Committee meetings;
- Provide recommendation and support to countries to ensure local regulatory QDs are developed and maintained only for topics that are not covered at global level and that answer very specific local regulation
- Provide support to the yearly Quality review.
- Collaborate with the other GRA Q&CI sub-units (audit/inspection readiness and deviation/risk management) to ensure resolution of CAPAs, follow-up of deviations when linked to QD.
- Work in collaboration with Regulatory Quality Training Manager to:
- ensure alignment between applicability of QDs and GRA role training assignment
- analyse GRA and non GRA QDs and adapt accordingly GRA training certifications whenever needed.
Knowledge, Skills & Competencies / Language
- Strong knowledge of current regulatory requirements (FDA, EMEA, ICH);
- High degree of personal accountability and commitment;
- Ability to independently prioritize assignments and provide timelines for project completion to direct reports or Working Group members, monitor process, progress and results;
- Excellent communication and collaboration with project teams, departmental associates, internal and external partners;
- Able to independently provide expert level of guidance to associates on questions relating to GRA Quality Documents, processes, and relevant regulations;
- Ability to recognize issues that may require escalation to senior management levels and/or monitoring;
- Ability to work in a transversal organization;
- Expertise in meeting management, with strong group facilitation skills to lead effective cross-location and cross-functional meetings, net meetings, and teleconferences through discussions on complex and potentially controversial topics;
- Ability to multi-task, handling a wide range of small, medium, and long-term assignments in parallel and dealing with urgent issues as they arise;
- Anticipates problems, issues, and delays; works proactively and takes the initiative for any corrective measures;
- Excellent written and verbal skills;
- Fluency in English (both written and verbal skills) to interact effectively in an international environment.
- Formal degree in a relevant scientific/health-related field (minimum 5 years);
- Minimum of 10 years’ experience in the pharmaceutical industry, with a minimum of 5 years’ experience in Quality or Regulatory;
- Demonstrated ability to work within a global team/environment to produce operational reference standards to meet regulatory requirements across regions.
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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