Director, Digital QMS & Quality Governance

MSD; Wilmington (DE); Híbrido; USD 173.000 - 273.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical Insurance

Dental Insurance

Vision Healthcare

Retirement Benefits

401(k)

Paid Holidays

Vacation

Sick Days

Descripción de la vacante

MSD is seeking an experienced Director– Quality Management Systems (QMS) & Digital Quality Governance to lead the QMS workstream within a global laboratory transformation program. You will architect and deploy a modern digital QMS integrated with LIMS/ELN and automated workflows, ensuring compliance and efficiency across global operations.

You will direct strategy for deviation management, investigations, CAPA, change control, and validation, while embedding data integrity and CSA principles.

Formación

• Experience designing and overseeing enterprise-level QMS in cgmp laboratories.
• Strong knowledge of Data Integrity expectations and regulatory requirements (21 CFR Part 11/EU Annex 11).
• Experience with inspections by global health authorities (FDA/EMA/PMDA) and regulatory dossiers.

Responsabilidades

• Define, lead, and execute QMS integration strategy for the lab transformation program.
• Oversee eQMS; review and understand underlying code for compliance.
• Embed Data Integrity by Design (ALCOA+) and CSA into digitized laboratory platforms.
• Ensure QMS processes comply with global cGMP regulations and SOPs; drive inspection readiness.
• Direct QMS governance, track milestones, risks, and interdependencies; reporting to executives.
• Drive change management and training to enable digitized QA workflows across sites.
• Collaborate across operations, technology, regulatory affairs, and validation teams.
• Mentor quality specialists and oversee external vendors in regulated environments.

Conocimientos

Analytical Development

Cross-Functional Leadership

Digital Transformation

Enterprise Transformation

Executive Communications

GMP Compliance

Laboratory Quality Control

Project Governance

Quality Management Systems

Regulatory Strategies

Educación

Bachelor’s degree in a related science field

Advanced degree preferred (Master’s, PhD, PharmD, or MBA)

Herramientas

LIMS

ELN

CDS

SDMS

TrackWise

Veeva Vault QMS

Descripción del empleo

MSD is seeking an experienced Director– Quality Management Systems (QMS) & Digital Quality Governance to lead the QMS workstream within a global laboratory transformation program. You will architect and deploy a modern digital QMS integrated with LIMS/ELN and automated workflows, ensuring compliance and efficiency across global operations.

You will direct strategy for deviation management, investigations, CAPA, change control, and validation, while embedding data integrity and CSA principles.