Director– Quality Management Systems; QMS Digital Quality Governance

Position: Director– Quality Management Systems (QMS) & Digital Quality Governance
## Director– Quality Management Systems (QMS) & Digital Quality Governance Apply:
Hybrid:
USA
- Delaware
- Wilmington (Biotech):
USA
- New Jersey
- Rahway:
USA
- Pennsylvania
- West Point:
Full time:
Posted Today:
End Date:
December 3, 2026 (27 days left to apply):
R424136
** Job Description**##
** Position Overview*
* ** Quality Lead, Director– QMS & Digital Quality Governance Analytical
**** Global Quality Management Systems
** The Global Quality Group within our Company Manufacturing Division is seeking an experienced transformation lead in the capacity of
** Director– Quality Management Systems (QMS) & Digital Quality Governance,
** to provide strategic and operational leadership for the QMS workstream within a complex, enterprise-level laboratory transformation program.

This role is accountable for architecting, modernizing, and deploying a modernized, digitized Quality Management System tailored to support next-generation QC testing, end-to-end analytical digitization, instrumentation innovation, and laboratory automation.

The QMS Quality Lead will oversee the harmonization and evolution of quality processes—including deviation management, investigations, CAPA, change control, risk management (ICH Q9), and computerized systems validation (CSV/CSA)—to ensure seamless integration with modern automated laboratory workflows, LIMS, ELN, and digital data pipelines. In close partnership with the program leadership team, Site Quality heads, Analytical Development, Digital/IT Quality, and Regulatory Compliance, the incumbent will ensure that innovative operational models maintain rigorous compliance with global health authority regulations while driving efficiency, inspection readiness, and continuous improvement.

** Key Responsibilities and Requirements
** The ideal candidate will combine deep technical expertise in global Quality Management Systems with a forward-thinking innovation mindset, translating digital and automated laboratory advancements into agile, compliant, and sustainable QMS frameworks.
* ** Strategic QMS Architecture & Modernization:
** Define, lead, and execute the QMS integration strategy for the lab transformation initiative, ensuring core quality processes (Change Control, OOS/OOE/OOT investigations, Deviations, CAPA, Method Transfer/Validation, and Batch Release support) are optimized, digitized, and natively integrated with automated laboratory systems
* ** Coding

Experience:

** Experience and understanding on how coding translates to QMS and analytical functions.
Responsible for overseeing the eQMS  and ability to be able to review and understand the underlying code and how it is ensures compliance.
* ** Digital Quality & Data Integrity Governance:
** Partner with IT/Digital Quality and Automation engineers to embed robust Data Integrity by Design (ALCOA+) and Computer Software Assurance (CSA) principles into digitized laboratory platforms, instrument interfaces, and automated data flows.
* ** Regulatory Compliance & Inspection Readiness:
** Ensure all modernized QMS processes, policies, and standard operating procedures (SOPs) comply with global cGMP regulations (FDA 21 CFR Part 11/210/211, EU Annex 11, ICH Q9/Q10, WHO). Drive inspection readiness strategies and author/review corresponding regulatory briefing documents and filing sections.
* ** Matrixed Program Leadership & Governance:
** Direct the QMS workstream governance forum, actively tracking milestone execution, interdependencies, risks, and critical paths. Provide regular data-driven progress updates, risk assessments, and escalation pathways to the Overall Quality Lead and executive steering bodies.
* ** Change Management & Operational Transition:
** Drive human-centered change management and training initiatives to support…