Director, Digital QMS & Quality Governance (Hybrid)

Merck; Rahway (NJ); Híbrido; USD 173.000 - 273.000; Jornada completa

Descripción de la vacante

Merck seeks a Director- Quality Management Systems (QMS) & Digital Quality Governance to lead the QMS workstream within a complex laboratory transformation program. You will architect, modernize, and deploy a digitized QMS aligned with next‑gen QC testing, laboratory automation, and regulatory compliance.

You will collaborate with IT, QA, Regulatory, and site leadership to ensure data integrity, CSA, and risk management across LIMS/ELN and QMS integrations.

Formación

• Bachelor’s degree in Chemistry, Biochemistry, Pharmacy, Engineering, Life Sciences, or related discipline required; advanced degree strongly preferred.
• 10+ to 15+ years of progressive experience in pharmaceutical/biopharmaceutical quality operations, quality systems, or compliance within a cGMP manufacturing and QC laboratory environment.
• Quality Systems Expertise: Proven track record in designing, optimizing, and overseeing enterprise-level QMS processes (Deviations, Investigations, CAPA, Change Control, Out of Specification, and Quality Risk Management) in laboratories subject to global health authority inspections (e.g., FDA, EMA, PMDA).
• Digital & Laboratory Systems Acumen: In-depth knowledge of laboratory digital ecosystems, including LIMS, ELN, CDS, SDMS, automated instrumentation, and their integration into enterprise QMS platforms (e.g., TrackWise, Veeva Vault QMS).
• Validation & Compliance Mastery: Strong understanding of Data Integrity expectations, 21 CFR Part 11, EU Annex 11, and modern risk-based validation methodologies (GAMP 5, Computer Software Assurance).
• Governance & Program Execution: Demonstrated success leading large-scale cross-functional workstreams, setting project milestones, proactively managing risk registers, and driving accountable execution.
• Communication & Influencing: Exceptional written and verbal communication skills, with proven ability to present technical compliance strategies effectively to executive sponsors, auditors, and technical teams.

Responsabilidades

• Strategic QMS Architecture & Modernization: Define, lead, and execute the QMS integration strategy for the lab transformation initiative, ensuring core quality processes are digitized and integrated with automated laboratory systems.
• Coding Experience: Oversee eQMS and understand underlying code to ensure compliance.
• Digital Quality & Data Integrity Governance: Partner with IT/Digital Quality to embed ALCOA+ and CSA principles into digitized platforms and data flows.
• Regulatory Compliance & Inspection Readiness: Ensure QMS processes comply with global regulations; drive inspection readiness and author regulatory documents.
• Matrixed Program Leadership & Governance: Direct governance forum, track milestones, risks, and provide data-driven updates.
• Change Management & Operational Transition: Drive change management and training for site-level adoption of digitized workflows.
• Cross-Functional Collaboration: Serve as central quality authority across labs, development, validation, and regulatory affairs to remove silos.
• People Leadership & Oversight: Mentor quality specialists and external consultants, maintaining high standards.

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 Chemistry, Biochemistry, Pharmacy, Engineering, Life Sciences, or related discipline

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

Herramientas

LIMS

ELN

CDS

SDMS

TrackWise

Veeva Vault QMS

Descripción del empleo

Merck seeks a Director- Quality Management Systems (QMS) & Digital Quality Governance to lead the QMS workstream within a complex laboratory transformation program. You will architect, modernize, and deploy a digitized QMS aligned with next‑gen QC testing, laboratory automation, and regulatory compliance.

You will collaborate with IT, QA, Regulatory, and site leadership to ensure data integrity, CSA, and risk management across LIMS/ELN and QMS integrations.