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MSD

Director, Quality Oversight – Contract Testing Laboratories

MSD

. Lead strategy, organisational design, budget oversight and performance management for contract testing laboratories and the cell bank quality oversight organisation .

Posted 10/22/2026full-timeRemote • Pennsylvania • United States, Netherlands, Ireland, SwitzerlandLead💰 $173,200 - $272,600 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates extensive experience in Quality Systems, Quality Assurance, and Quality Control within pharmaceutical manufacturing, with a strong focus on compliance, risk management, and operational excellence. Proven ability to lead teams, manage quality investigations, and establish governance routines to enhance performance and ensure regulatory compliance.

Highest-signal resume keywords
Quality Assurance ManagementGMP ComplianceRisk-Based Quality ManagementTeam Leadership and DevelopmentRegulatory Inspection Support

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Quality SystemsQuality ControlQuality Governance ModelsAnalytical Technology TransferData-Driven Decision MakingQuality InvestigationsPerformance Metrics DefinitionOperational Performance ImprovementSupplier OversightContinuous Improvement Initiatives
Soft Skills
Operational ExcellenceProactive Problem-SolvingCollaborationAccountabilityMentoring
Industry Keywords
Pharmaceutical ManufacturingGLPHealth Authority RequirementsBiologicsVaccinesContract Testing LaboratoriesCell BankingQuality AgreementsMultinational Organization LeadershipSupply Chain Management

About the role

Key responsibilities & impact
  • Lead strategy, organisational design, budget oversight and performance management for contract testing laboratories and the cell bank quality oversight organisation
  • Establish and maintain risk-based quality oversight models for contract testing laboratories and cell banking
  • Provide operational leadership to contract testing laboratories accountable for drug substance, drug product and finished product testing
  • Provide Quality oversight to ensure products are tested, stored and retained in accordance with regulatory expectations, GLP, GMP and company requirements
  • Oversee resolution of quality issues, out-of-specification investigations and deviations that could impact launch or supply continuity
  • Provide Quality oversight for analytical technology transfer
  • Define performance expectations, metrics and governance routines to monitor and improve quality and operational performance
  • Lead Quality assessments for prospective contract test laboratories or new method citing and ensure gaps are remediated
  • Establish and maintain Quality agreements
  • Direct, mentor and develop a high-performing team of quality assurance professionals
  • Promote accountability, collaboration, operational excellence and proactive problem-solving across internal and external testing networks

Requirements

What you’ll need
  • Bachelor’s degree in a scientific discipline required
  • Minimum of ten (10) years of experience in Quality Systems, Quality Assurance, and/or Quality Control within pharmaceutical manufacturing operations under global GMP and health authority requirements
  • Proven track record managing complex quality investigations, assessing risk, and making timely, data-driven decisions
  • Strong compliance background with experience supporting regulatory inspections and health authority interactions
  • Demonstrated success leading and developing teams
  • Ability to travel approximately 30% of the time, including occasional short-notice travel
  • Advanced degree in a relevant scientific or technical field preferred
  • Experience leading external partners across biologics or vaccines preferred
  • Prior leadership of a multinational organization with direct accountability for partner performance, compliance, and supply support preferred
  • Strong knowledge of quality governance models, supplier oversight, and risk-based quality management systems preferred
  • Experience partnering with leadership at external partners to influence performance, strengthen quality systems, and accelerate remediation preferred
  • Broader exposure to operations, engineering, supply chain, and commercial functions preferred
  • Experience leading transformation, standardization, or continuous improvement initiatives preferred
  • No visa sponsorship

Benefits

Comp & perks
  • Annual bonus and long-term incentive, if applicable
  • Medical, dental, vision healthcare and other insurance benefits for employee and family
  • Retirement benefits, including 401(k)
  • Paid holidays
  • Vacation
  • Compassionate and sick days
  • Remote work arrangement
  • No relocation