Associate Director, Internal Auditing

MSD

Associate Director leading internal audits and GMP compliance for Merck’s prescription medicines, vaccines, and animal health products. Driving inspection readiness, quality systems, risk management, and continuous improvement across development operations.

Posted 8/5/2026full-timeWest Point • New Jersey, Pennsylvania • 🇺🇸 United StatesSenior💰 $129,000 - $203,100 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive knowledge of FDA and EU GMP regulations, quality assurance, and compliance standards, with a strong ability to lead audits and cross-functional teams. Proficient in developing metrics and key performance indicators to enhance quality performance and operational excellence.

Highest-signal resume keywords

GMP ComplianceComputer System Validation (CSV)Quality Systems ComplianceRegulatory ComplianceLeadership Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

GMP RegulationsQuality AssuranceQuality ControlSystem Document LifecycleAudit LeadershipRisk AssessmentLean Sigma PrinciplesSterile Manufacturing KnowledgeHealth Authority Inspection ExperienceDigital Tools Proficiency

Soft Skills

Attention to DetailVerbal CommunicationWritten CommunicationPresentation SkillsProject Management

Tools & Technologies

MS PowerPointMS ExcelMS WordDelta-VPAS-XSAPElectronic Laboratory NotebooksVeevaLIMSEmpower

Industry Keywords

Pharmaceutical IndustryBiopharmaBiologicsCGMPICH GuidelinesClinical SupplyQuality Risk ManagementAseptic Processing GuidelinesInvestigational Medicinal ProductsContinuous Compliance

About the role

Key responsibilities & impact

Develop, implement, and maintain processes and procedures supporting continuous compliance of investigational medicinal products with cGMPs and international regulations
Lead and support comprehensive internal audits and assessments of GMP facilities and business applications or systems supporting clinical supplies manufacture, testing, storage, and distribution
Issue audit reports, track resulting actions to satisfactory closure, and maintain appropriate site risk posture
Develop metrics and key performance indicators to measure trends and improve quality performance
Escalate unresolved issues and trends to management
Present audit outcomes to management and governing Quality Councils when applicable
Provide guidance and interpretation of GMP, regulatory, and compliance standards
Develop and harmonize compliance procedures and processes aligned with worldwide regulations and industry standards
Lead and support GMP readiness activities for new manufacturing facilities, laboratories, and support areas
Support preparation and execution of Health Authority Inspections and company audits
Promote quality and operational excellence
Identify and implement improvement opportunities across multiple organizations
Represent Development Quality on inter-departmental and cross-functional teams
Support risk identification and remediation for risk assessments

Requirements

What you’ll need

Required: Bachelor's Degree in appropriate Science, IT, or Engineering discipline
Minimum 8 years of experience in the pharmaceutical, biopharma/biologics, or related industry
Experience in multiple functional areas such as quality assurance, computer system validation, quality control, manufacturing, research and development, supply chain, facilities, and engineering
Extensive knowledge of FDA and EU GMP regulations and ICH guidelines
Demonstrated knowledge and direct experience applying System Document Lifecycle requirements in GMP areas
Experience leading audits
Ability to travel between West Point, PA and Rahway, NJ
Strong leadership skills and ability to lead cross-functional teams
Experience using electronic quality systems to monitor, report, and track quality tasks and KPIs
Excellent attention to detail
Proficiency with digital tools and computer applications, including MS PowerPoint, Excel, and Word
Excellent verbal, written communication, and presentation skills
Ability to prioritize and manage multiple projects and tasks independently
Preferred: Advanced degree
Preferred: Familiarity with R&D or clinical supply areas and processes
Preferred: Experience with Delta-V, PAS-X, SAP, electronic laboratory notebooks, Veeva, LIMS, or Empower
Preferred: Experience using AI tools and applications
Preferred: Quality Risk Management tools experience
Preferred: Experience leading or supporting US and EU health authority inspections
Preferred: Understanding of lean sigma principles and tools
Preferred: Sterile manufacturing experience and knowledge of US and EU aseptic processing guidelines
Required skills: Computer System Validation (CSV), GMP Compliance, Medical Device Regulations, Quality Systems Compliance, Regulatory Compliance
Valid driving license required
No visa sponsorship

Benefits

Comp & perks

Annual bonus eligibility
Long-term incentive eligibility, if applicable
Medical, dental, and vision healthcare
Other insurance benefits for employee and family
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Flexible work arrangements: Hybrid