Associate Director, Quality Systems - Hybrid

MSD

4d • Hybrid

About The Position

The Compliance and Quality Management Systems (CQMS) organization is part of the larger Global Development Quality (GDQ) organization within our Company's Research Laboratory Quality Assurance and is responsible for the execution of critical activities in the areas of compliance, quality systems, regulatory intelligence and the Quality Management System (QMS). The Associate Director, Quality Systems is responsible for execution, oversight, and continuous improvement of globally governed quality system processes in support of the clinical supply chain for investigational medicinal product within our company's Global network. The position strengthens the effectiveness, consistency, and sustainability of deviation management, CAPA, change control, quality risk management, and data governance during a period of heightened regulatory focus and organizational transformation.

Requirements

• 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.

Nice To Haves

• Proven ability to drive continuous improvement and standardization across complex quality systems.
• Strong analytical, problem-solving, and decision-making skills.
• Effective oral and written communication, with the ability to influence across organizational boundaries.
• Experience working within globally governed models and partnering with site and functional stakeholders.
• Ability to manage ambiguity while maintaining rigor, consistency, and control.
• Effective negotiation skills and project management abilities.

Responsibilities

• 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.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level