Associate Director, Quality Assurance

MSD

. Execute, oversee, and continuously improve globally governed quality system processes supporting the clinical supply chain for investigational medicinal product .

Posted 10/15/2026full-timeUnited StatesSenior💰 $129,000 - $203,100 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Quality Systems and Compliance within the pharmaceutical or biotechnology industry, with a strong focus on GxP requirements, continuous improvement, and data integrity. Proven ability to lead cross-functional initiatives and drive standardization across complex quality systems.

Highest-signal resume keywords

Quality Systems ComplianceGxP RequirementsQuality Risk ManagementDeviation ManagementData Integrity

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Assurance SystemsCompliance InvestigationsGood Manufacturing Practices (GMP)Process StandardizationProject Leadership

Soft Skills

Analytical SkillsProblem-SolvingDecision-MakingEffective CommunicationNegotiation Skills

Industry Keywords

Pharmaceutical IndustryBiotechnology IndustryQuality ComplianceQuality OversightTraining and Development

About the role

Key responsibilities & impact

Execute, oversee, and continuously improve globally governed quality system processes supporting the clinical supply chain for investigational medicinal product
Drive Quality Systems Transformation initiatives covering deviation management, CAPA effectiveness, change management, quality risk management, and data governance
Strengthen standardization and continuous improvement of global quality system processes
Reinforce data governance and data integrity controls
Provide quality system expertise to maintain process control and compliance with global regulatory requirements and internal standards
Act as a change agent for durable quality system and quality culture improvements through governance and traceability
Partner cross-functionally with site and functional teams to identify systemic gaps, influence adoption of global standards, and implement sustainable solutions
Develop and monitor quality system metrics and key performance indicators
Author, review, and approve quality system documentation and governance materials
Maintain expert-level knowledge of GxP requirements, regulatory expectations, and industry trends, providing interpretation and guidance to stakeholders

Requirements

What you’ll need

B.S., M.S., or Ph.D. in a science or engineering discipline
Minimum 8 years of experience in the pharmaceutical or biotechnology industry with a B.S. or M.S., or 5 years with a Ph.D.
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
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 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
Required skills: Compliance Investigations, Data Integrity, Deviation Management, Good Manufacturing Practices (GMP), Managing Ambiguity, Process Standardization, Project Leadership, Quality Assurance Systems, Quality Compliance, Quality Oversight, Quality Risk Management, Quality Systems Compliance, Training and Development
No visa sponsorship

Benefits

Comp & perks

Annual bonus
Long-term incentive, if applicable
Medical, dental, and vision healthcare
Other insurance benefits for employee and family
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate days
Sick days
No relocation