The Associate Director, Data Quality &Integrity (Global R&D & PV QA) 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. This role leads cross‑functional initiatives, establishes program‑level oversight frameworks, mentors and develops QA capability, and partners with senior stakeholders to ensure robust data governance, regulatory compliance, and measurable continuous improvement.
The incumbent reports to the Head of Global Data Quality and Integrity (Global R&D & PV QA).
JOB DESCRIPTION
- Leadership & Strategy Execution - 20%
· 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 – 30%
· 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 – 20%
· 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 — 20%
· 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 – 10%
· 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.
JOB REQUIREMENTS
· Bachelor’s degree or Master's degree in Life Sciences, Pharmacy, IT, or related discipline is required.
· 10–15 years of experience in 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.
· Experience leveraging metrics, analytics, and AI‑enabled technologies to drive continuous improvement and digital transformation in QA oversight and data integrity governance.
· Fluency in English (oral and written); Chinese (oral and written) is advantageous.
· 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.
· Highly effective executive communication skills, with the ability to clearly articulate risk, strategy, and compliance expectations to technical and non‑technical leaders.
· People leadership and capability building, coaching and mentoring QA staff and building sustainable practices through standardization, training, and lessons learned.
· Data‑driven and improvement‑oriented, leveraging metrics, trend analysis, analytics, and new technologies to improve compliance outcomes and inspection readiness.
