Director, Quality Assurance

MSD•San Jose, CA

2d•Hybrid

About The Position

The Director, Safety Data Analyst (M-Track) provides strategic and operational leadership for global Safety Data Management (SDM), ensuring excellence in pharmacovigilance case management, medical coding, compliance, quality oversight, and system enablement. This role drives process innovation, inspection readiness, digital transformation, and operational effectiveness while leading high-performing teams and partnering across Global Clinical Safety & Pharmacovigilance, Technology, and Data organizations.

Requirements

Bachelor's degree with 10+ years, or Advanced degree with 8+ years of relevant experience, including significant biopharmaceutical industry experience and 3+ years of people leadership experience.
Deep expertise in ICSR management, medical coding, pharmacovigilance regulations, and Safety Data Management.
Strong understanding of safety systems, coding platforms, reporting tools, automation, and system validation.
Experience leading regulatory inspections, audits, quality oversight, and operational performance management.
Knowledge of resource planning, capacity management, and process optimization.
Exceptional communication and stakeholder management skills.
Proven ability to lead through influence in complex global environments.
Strong strategic thinking, problem-solving, and change management capabilities.
Demonstrated success building collaborative, inclusive, and high-performing teams.
Ability to translate complex scientific, medical, and regulatory information into business decisions.
Adaptability
Case Management
Clinical Data Management
Data Validation
Decision Making
eCRF
Ethical Standards
Good Clinical Data Management Practice (GCDMP)
Good Clinical Practice (GCP)
Medical Insurance Coding
Mentoring Staff
Metadata Management
Mitigated Risks
Organizational Performance Management
People Leadership
Pharmacovigilance
Process Standardization
Psychological Safety
Risk Mitigation Strategies
Standard Operating Procedure (SOP)
Strategic Leadership
Strategic Thinking
Study Data Tabulation Model (SDTM)
System Validation

Responsibilities

Lead global Safety Data Management processes, governance, and documentation to ensure compliance, quality, and inspection readiness.
Drive continuous improvement, simplification, and automation of SDM processes and technologies.
Provide strategic direction for safety case management, medical coding, and operational performance across geographies.
Monitor industry, regulatory, and technology developments and translate them into business improvements.
Ensure adherence to SOPs, GxP, ICH-GCP, pharmacovigilance regulations, and enterprise standards.
Oversee quality management activities, governance frameworks, training strategies, and process controls.
Support regulatory inspections, audits, CAPA management, and resolution of compliance findings.
Maintain global consistency across documentation, training, and operational practices.
Partner with Global Clinical Safety & Pharmacovigilance, GDIA, IT, and vendors to optimize systems, workflows, automation, and data integration.
Influence technology roadmaps, system enhancements, and digital capabilities that improve efficiency and compliance.
Lead implementation of system releases and process changes to ensure business continuity and operational readiness.
Develop business cases and recommendations to support investment and prioritization decisions.
Lead and develop a high-performing global organization through coaching, succession planning, talent development, and performance management.
Establish clear goals, priorities, and accountability aligned with organizational strategy.
Partner with HR on recruitment, workforce planning, employee relations, and organizational capability building.
Manage resources and budgets to ensure effective delivery against business priorities.