Associate Director, Data Quality & Integrity, Global R&D & PV QA
Job Summary
The Associate Director, Data Quality & Integrity (Global R&D & PV QA) at Daiichi Sankyo provides strategic and tactical leadership for quality assurance governance of data integrity and GxP computerized systems across R&D, Pharmacovigilance (PV), and Medical Affairs (MA), with emphasis on business operational data.
Responsibilities
Leadership & Strategy Execution – Lead execution of key elements of the global Data Integrity strategy and ensure alignment across R&D, PV, and MA. Translate strategic objectives into multi-year roadmaps and annual operating plans for data integrity and computerized systems oversight (business operational data focus). Serve as a senior subject matter expert for data integrity and GxP computerized systems governance, advising leadership on risk-based prioritization and compliance posture.
Quality & Compliance Oversight – Provide QA leadership for high-risk or complex GxP computerized systems and related business operational data processes across the system lifecycle. Oversee risk-based validation, periodic review, change governance, and sustained compliance activities; drive consistent application of global QA standards. Establish and monitor portfolio-level compliance oversight mechanisms (governance forums, escalation pathways, decision rights) for inspection readiness.
Audit, Inspection & Risk Management – Lead QA activities for audits and regulatory inspections related to computerized systems and data integrity; coordinate cross-functional readiness and responses. Review and approve investigations, deviations, and CAPAs for complex/high-impact issues; ensure root cause quality and effectiveness verification. Identify, trend, and mitigate emerging compliance risks; drive proactive risk reduction actions across functions and vendors.
Stakeholder Engagement & People Leadership – Partner with senior stakeholders across R&D, PV, MA, IT, and Global QMS/eCompliance to drive alignment on governance, priorities, and risk acceptance. Provide coaching and mentoring to QA staff and/or cross-functional teams; support capability building and adoption of consistent DI practices. Lead cross-functional teams to deliver complex initiatives and resolve escalations that span multiple organizations or regions.
Continuous Improvement & Innovation – Drive continuous improvement initiatives using metrics, analytics, and trend insights to improve DI performance and inspection readiness. Support adoption of advanced analytics, AI-enabled solutions, and emerging technologies to strengthen QA oversight and enable digital transformation in Global R&D & PV QA.
Qualifications
Education Qualifications: Bachelor's Degree in Life Sciences, Pharmacy, IT or related field required. Master's degree or higher level degree such as a doctorate preferred.
Experience Qualifications: 7 or more years of Quality Assurance, IT compliance/CSV, and/or regulated pharmaceutical environments supporting R&D, PV, and MA. Demonstrated leadership of complex, cross-functional initiatives for data integrity and GxP computerized systems governance (portfolio/program level). Strong experience leading audit and inspection readiness activities, including review/approval of investigations and CAPA strategies for high-impact issues. Experience operating effectively in global, matrixed organizations with senior stakeholder engagement and enterprise risk management is preferred. Experience leveraging metrics, analytics, and AI-enabled technologies to drive continuous improvement and digital transformation in QA oversight and data integrity governance is preferred.
Skills: Fluency in English (oral and written). Demonstrated ability to set direction and provide QA governance for data integrity and computerized systems across R&D, PV, and MA, including business operational data. Strong strategic thinking and execution discipline, translating strategy into roadmaps, operating plans, and measurable outcomes while managing competing priorities and risk-based decisions. Proven capability to lead complex, cross-functional and multi-regional initiatives, influencing senior stakeholders and driving alignment on governance and compliance posture. Excellent risk management and decision-making skills, anticipating emerging risks, driving preventive actions, and ensuring investigations and CAPA effectiveness for high-impact issues.
Skill Set
Strategic Thinking
Leadership
Quality Assurance
Data Integrity
Computerized Systems Governance
Regulatory Compliance
Continuous Improvement
Innovation
Benefits
Not specified
Pay
USD$153,600.00 - USD$230,400.00
Schedule
Not specified