Associate Director, Quality Systems

MSD

Associate Director of Quality Systems in a pharmaceutical company ensuring compliance and quality in investigational medicinal products. Leading transformation initiatives and cross-functional collaboration for quality practices.

Posted 5/13/2026full-timeRahway • New Jersey, Pennsylvania • 🇺🇸 United StatesSenior💰 $129,000 - $203,100 per yearWebsite

About the role

Key responsibilities & impact

Drive Quality Systems Transformation initiatives focused on deviation management, CAPA effectiveness, change management, quality risk management, and data governance.
Strengthen standardization and continuous improvement of global quality system processes to ensure consistent application, transparency, and inspection readiness.
Establish and reinforce master data management and data integrity controls that underpin right-first-time execution and regulatory confidence.
Provide quality system expertise to ensure processes remain in a state of control, compliant with global regulatory requirements and internal standards.
Act as a change agent to enable durable quality system and quality culture improvements through system-level rigor, governance, and traceability.
Partner cross-functionally with site and functional teams to identify systemic gaps, influence adoption of global standards, and implement sustainable solutions.
Support management oversight activities by developing and monitoring quality system metrics and key performance indicators.
Author, review, and approve quality system documentation and governance materials in accordance with established procedures.
Maintain expert-level knowledge of GxP requirements, regulatory expectations, and industry trends, providing interpretation and guidance to stakeholders.

Requirements

What you’ll need

Minimum 8 years (B.S./M.S.) or 5 years (Ph.D.) in the pharmaceutical or biotechnology industry.
Demonstrated experience in Quality Systems, Quality Assurance, Compliance, or related GxP-regulated roles.
Extensive working knowledge of global GxP requirements and Pharmaceutical Quality System principles.

Benefits

Comp & perks

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

deviation managementCAPA effectivenesschange managementquality risk managementdata governancemaster data managementdata integrity controlsquality system metricskey performance indicatorsquality system documentation

Soft Skills

cross-functional collaborationinfluencesystem-level rigorgovernancetraceabilitycontinuous improvementstandardizationcommunicationleadershipchange agent