Continuous Improvement & Performance Manager
Sanofi
22 days ago
Remote friendly (Cambridge, MA)
United States
$113,250 - $163,583.33 USD yearly
Operations
Main Responsibilities:
- Lead end-to-end management of GRA Quality Documentation (QD) system within QualiPSO (CMS), ensuring compliance with Global Quality (GQ) standards and MCCQ-specific requirements.
- Define, implement, and maintain the GRA QD system aligned with GQ, MCCQ, and regulatory frameworks including 21 CFR Part 211 and GxP.
- Manage full QD lifecycle (creation, revision, approval, distribution, periodic review, obsolescence) per QualiPSO procedures.
- Oversee Document Change Request (DCR) management and periodic review workflows, including SME assessments and verdicts (Keep Effective, Needs Revision, Make Obsolete).
- Administer QualiPSO workflows and electronic signatures; manage the annual Document Plan.
- Provide expert guidance for GxP-compliant documentation of regulatory processes; advise the Business Process Owner (BPO) network as a subject matter expert.
- Ensure consistency across GRA/MCCQ/GQ documents and eliminate redundancy (MOSAIC philosophy).
- Communicate QD updates; manage user access rights/permissions in QualiPSO.
Lead QD Training Strategy:
- Design and drive training strategy to ensure qualified, current personnel on applicable QDs.
- Collaborate to define/simplify Training Curricula; partner with the QD training Hub for implementation.
- Maintain training requirements rationale with evidence for traceability and audit readiness.
Drive Compliance & Continuous Improvement:
- Apply data/risk-based quality improvement to elevate compliance.
- Support audit finding and QD-related deviation CAPAs (remediation and effectiveness tracking).
- Identify and communicate QD process improvement opportunities; support quality reviews with metrics/trends/risk.
- Use quality risk management to identify documentation gaps early; foster continuous improvement culture.
Cross-Functional Collaboration:
- Represent GRA in global quality networks and committees/projects; coordinate transversal QD reviews.
- Facilitate SME requests for MCCQ processes; share best practices.
Qualifications/Requirements:
- BS/BA in a relevant scientific discipline.
- 5+ years relevant experience, including 2+ years in Regulatory Affairs.
- 2+ years GxP quality system management with hands-on QD lifecycle management.
- Advanced CMS proficiency; experience as both document controller and creator (preferably Veeva).
- Working knowledge of 21 CFR Part 211 and applicable GxP documentation/records standards.
- Demonstrated application of quality risk management and continuous improvement in regulated environments.
Skills:
- Strong planning/operational skills; ability to influence without direct authority; change-agent mindset.
- Excellent oral/written communication in global, cross-functional, multicultural environments.
- Strong analytical skills; ability to analyze complex issues and lead solution implementation.
- Proficiency in electronic document management systems (Veeva CMS), including project management for documentation projects.
- Lead end-to-end management of GRA Quality Documentation (QD) system within QualiPSO (CMS), ensuring compliance with Global Quality (GQ) standards and MCCQ-specific requirements.
- Define, implement, and maintain the GRA QD system aligned with GQ, MCCQ, and regulatory frameworks including 21 CFR Part 211 and GxP.
- Manage full QD lifecycle (creation, revision, approval, distribution, periodic review, obsolescence) per QualiPSO procedures.
- Oversee Document Change Request (DCR) management and periodic review workflows, including SME assessments and verdicts (Keep Effective, Needs Revision, Make Obsolete).
- Administer QualiPSO workflows and electronic signatures; manage the annual Document Plan.
- Provide expert guidance for GxP-compliant documentation of regulatory processes; advise the Business Process Owner (BPO) network as a subject matter expert.
- Ensure consistency across GRA/MCCQ/GQ documents and eliminate redundancy (MOSAIC philosophy).
- Communicate QD updates; manage user access rights/permissions in QualiPSO.
Lead QD Training Strategy:
- Design and drive training strategy to ensure qualified, current personnel on applicable QDs.
- Collaborate to define/simplify Training Curricula; partner with the QD training Hub for implementation.
- Maintain training requirements rationale with evidence for traceability and audit readiness.
Drive Compliance & Continuous Improvement:
- Apply data/risk-based quality improvement to elevate compliance.
- Support audit finding and QD-related deviation CAPAs (remediation and effectiveness tracking).
- Identify and communicate QD process improvement opportunities; support quality reviews with metrics/trends/risk.
- Use quality risk management to identify documentation gaps early; foster continuous improvement culture.
Cross-Functional Collaboration:
- Represent GRA in global quality networks and committees/projects; coordinate transversal QD reviews.
- Facilitate SME requests for MCCQ processes; share best practices.
Qualifications/Requirements:
- BS/BA in a relevant scientific discipline.
- 5+ years relevant experience, including 2+ years in Regulatory Affairs.
- 2+ years GxP quality system management with hands-on QD lifecycle management.
- Advanced CMS proficiency; experience as both document controller and creator (preferably Veeva).
- Working knowledge of 21 CFR Part 211 and applicable GxP documentation/records standards.
- Demonstrated application of quality risk management and continuous improvement in regulated environments.
Skills:
- Strong planning/operational skills; ability to influence without direct authority; change-agent mindset.
- Excellent oral/written communication in global, cross-functional, multicultural environments.
- Strong analytical skills; ability to analyze complex issues and lead solution implementation.
- Proficiency in electronic document management systems (Veeva CMS), including project management for documentation projects.