Director, Quality Assurance
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Job Summary
Job Description
Key Responsibilities
Strategic Leadership & Operational Excellence
- 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.
Quality Compliance & Inspection Readiness
- 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.
Technology & Cross-Functional Leadership
- 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.
People Leadership
- 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.
Qualifications & Experience
Required
- Bachelors 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.
Required Skills:
Adaptability 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 1 morePreferred Skills:
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Search Firm Representatives Please Read Carefully
Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
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RegularRelocation:
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Job Posting End Date:
08/13/2026*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Director
About Company
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicine ... View more
