Continuous Improvement & Performance Manager
Sanofi
3 hours ago
Remote friendly (Morristown, NJ)
United States
$113,250 - $163,583.33 USD yearly
Operations
Main Responsibilities
- Lead end-to-end management of GRA Quality Documentation (QD) within QualiPSO (CMS): compliance with Global Quality (GQ) and MCCQ requirements; define/maintain QD system aligned to GQ, MCCQ, and regulatory frameworks (including 21 CFR Part 211 and GxP).
- Manage QD document lifecycle (creation, revision, approval, distribution, review, obsolescence), Document Change Requests (DCRs), and periodic review workflows (SME assessments and verdicts: Keep Effective/Needs Revision/Make Obsolete).
- Administer workflow management and electronic signatures in QualiPSO; maintain the annual Document Plan; manage user access/permissions; provide QD/GxP guidance to Business Process Owners.
- Drive QD training strategy: develop training strategy, simplify curricula, partner with the QD training team/Hub, and maintain training rationale for traceability/audit readiness.
- Drive compliance and continuous improvement: support audit/deviation CAPA remediation for QDs, identify improvements with follow-up plans, provide QD metrics/trends/risk assessments, and apply quality risk management.
- Collaborate across global quality networks; coordinate transversal QD reviews and SME requests.
Qualifications (Required)
- BS/BA in a relevant scientific discipline.
- 5+ years relevant experience, including 2+ years in Regulatory Affairs (regional/global).
- 2+ years GxP Quality system management with hands-on QD lifecycle management.
- Advanced CMS proficiency (preferably Veeva) with document controller/creator experience.
- Working knowledge of 21 CFR Part 211 and applicable GxP documentation/records requirements.
Skills/Competencies
- Time management, stakeholder influence, discretion/confidentiality, change-agent mindset.
- Strong communication and analytical skills; project management; document lifecycle/DCR/review/e-signature expertise.
Benefits (if part of the job description)
- Healthcare and prevention/wellbeing programs; at least 14 weeks’ gender-neutral parental leave.
- Rewards package recognizing contribution.
- Lead end-to-end management of GRA Quality Documentation (QD) within QualiPSO (CMS): compliance with Global Quality (GQ) and MCCQ requirements; define/maintain QD system aligned to GQ, MCCQ, and regulatory frameworks (including 21 CFR Part 211 and GxP).
- Manage QD document lifecycle (creation, revision, approval, distribution, review, obsolescence), Document Change Requests (DCRs), and periodic review workflows (SME assessments and verdicts: Keep Effective/Needs Revision/Make Obsolete).
- Administer workflow management and electronic signatures in QualiPSO; maintain the annual Document Plan; manage user access/permissions; provide QD/GxP guidance to Business Process Owners.
- Drive QD training strategy: develop training strategy, simplify curricula, partner with the QD training team/Hub, and maintain training rationale for traceability/audit readiness.
- Drive compliance and continuous improvement: support audit/deviation CAPA remediation for QDs, identify improvements with follow-up plans, provide QD metrics/trends/risk assessments, and apply quality risk management.
- Collaborate across global quality networks; coordinate transversal QD reviews and SME requests.
Qualifications (Required)
- BS/BA in a relevant scientific discipline.
- 5+ years relevant experience, including 2+ years in Regulatory Affairs (regional/global).
- 2+ years GxP Quality system management with hands-on QD lifecycle management.
- Advanced CMS proficiency (preferably Veeva) with document controller/creator experience.
- Working knowledge of 21 CFR Part 211 and applicable GxP documentation/records requirements.
Skills/Competencies
- Time management, stakeholder influence, discretion/confidentiality, change-agent mindset.
- Strong communication and analytical skills; project management; document lifecycle/DCR/review/e-signature expertise.
Benefits (if part of the job description)
- Healthcare and prevention/wellbeing programs; at least 14 weeks’ gender-neutral parental leave.
- Rewards package recognizing contribution.