The Director, QRM, Global QMS, R&D & PV QA is accountable for establishing, governing, and continuous advancing a robust, science- and risk-based Quality Risk Management framework across R&D & Clinical Safety Pharmacovigilance, Medical Affairs and associated quality system.
This role serves as the global QA authority for quality risk management, providing independent oversight, governance, and strategic leadership to ensure that quality risk are proactively identified, assessed, controlled, communicated, and reviewed in alignment with ICH Q9 (R1), ICH Q10, company quality standards, and global regulatory expectations. The incumbent ensures that functional and cross-functional risk management activities are consistent, proportionate, traceable, inspection-ready and appropriately escalated within the QMS and enterprise risk management structures.
JOB DESCRIPTION
1. Global Quality Risk Management Framework
a. Lead the design, implementation, governance and continuous evolution of the global Quality Risk Management (QRM) framework across R&D, Pharmacovigilance, Medical Affairs, and associated quality systems, in alignment with ICH Q9 (R1), ICH Q10, and applicable global GxP regulations.
b. Establish and maintain standardized risk assessment methodologies, tools, templates, and governance models within the QMS.
c. Define, govern and maintain risk assessment principles, risk acceptance criteria, and quality risk posture for R&D & PV and MA, ensuring alignment with enterprise risk management and global quality strategy.
d. Own the multi-year QRM roadmap, including capability maturity, systems enablement, and integration with broader QMS and business processes.
2. Risk Identification, Assessment & Independent QA Oversight
a. Provide independent QA oversight and expert leadership for quality risk identification, assessments, control, communication, and review activities across the end-to-end product and system lifecycle.
b. Oversee and challenge quality risk assessment related to, but not limited to :
i. RDPVMA processes and systems
ii. Vendor, outsourcing and third-party activities
iii. Change management and transformation initiatives
iv. Inspection readiness, compliance, and systematic quality risks
c. Ensure quality risks are scientifically justified, proportionate, traceable and inspection-ready, with clear linkage to QMS records, mitigation actions, and management decisions.
d. Exercise QA authority to escalate, challenge, and influence decisions where risks are not adequately mitigated, understood, or appropriately accepted.
3. Governance, Integration & Management Review
a. Establish and lead quality risk governance structures, including escalation pathways and decision forum for critical, cross-functional or systemic risks.
b. Embed quality risk management outputs into key QMS processes, including Quality Event (QE) Management, CAPA, change control, supplier oversight, audit management and Quality Management Review.
c. Lead and shape risk-based inputs to management reviews and executive quality governance, providing clear visibility of risk trends, emerging issues, and mitigation effectiveness.
d. Ensure alignment and traceability between functional risk registers, QMS risk records, and enterprise-level risk reporting.
4. Digital Enablement, Metrics & Continuous Improvement
a. Own and evolve digital QRM tools, dashboards, and analytics to support proactive, data-driven risk identification, trending, escalation, and decision-making.
b. Define and monitor QRM performance indicators and effectiveness metrics, ensuring meaningful insights for senior management and continuous inspection readiness.
c. Drive continuous improvement of quality risk management practices based on audit outcomes, inspection findings, key trends, and performance data.
5. Regulatory Intelligence, Audit & Inspection Readiness
a. Monitor, interpret, and translate evolving global regulatory expectations and inspection trends (e.g. ICH Q9 (R1), regulatory and inspection focus area) into QRM strategy, standards and training.
b. Provide leadership and oversight for risk-based audit preparation, inspection readiness, and regulatory interactions related to quality risk management.
c. Support and guide organizational responses to inspection observations, audit findings, and regulatory commitment where quality risk management is impacted.
6. Cross‑Functional & Third-Party Risk Oversight
a. Partner closely with global stakeholders across R&D, Clinical Safety Pharmacovigilance, Medical Affairs, Regulatory Affairs, IT, Procurement, and vendor Quality to ensure effective, consistent, and compliance implementation of quality risk management.
b. Provide governance and QA oversight of third party and vendor risk management programs, ensuring alignment between internal quality expectation and external partner practices.
c. Influence cross-functional and matrix teams to embed risk-based thinking into strategic and operational decision-making.
7. Training & Capability Building & Quality Culture
a. Act as global quality risk management thought leader and champion, strengthening organizational capability through targeted training, coaching, and mentoring.
b. Develop and deliver QRM training curricula to ensure consistent understanding and practical application of risk management principle across regional and functions.
c. Promote and reinforce a strong quality culture that emphasizes proactive risk identification, transparency, prevention and accountability.
JOB REQUIREMENTS
- Bachelor’s degree in Life Sciences, Pharmacy, Medicine, Engineering, or a related scientific or technical discipline.
- Advanced degree (PhD, PharmD, MSc, MPH, MBA) or equivalent professional experience in a regulated pharmaceutical or biotechnology environment is preferred.
- 8–12+ years of progressively responsible experience in pharmaceutical quality, compliance, quality risk management, or regulated GxP environments, with demonstrated experience operating at a global and cross-functional level.
- Proven track record in establishing, governing and sustaining quality risk management framework within a global Quality Management System, including practical application of ICH Q9 (R1) and integration with ICH Q10.
- Strong experience providing independent QA oversight across R&D and Pharmacovigilance and Medical Affairs with exposure to multiple GxP domains (e.g. GCP, GVP, GLP, and GxP computerized systems).
- Demonstrate experience supporting regulatory inspections, health authority interactions, internal and external audits, including risk-based reparation, issue management, and inspection response.
- Experience partnering with senior stakeholders in global, matrixed organizations, influencing without authority and balance compliance, risk and business objectives.
- Experience overseeing or governing third-party, vendor, and outsourcing risks, including alignment of internal quality standards with external partner practices.
- Exposure to digital quality system, risk analytics, metrics, or dashboards is highly desirable.
- Deep expertise in quality management principles, risk-based decision making, and proportional application of controls in regulated environments.
- Strategic and system-level thinking with the ability to translate regulatory expectations and inspection trend into practical, sustainable QRM practices.
- Strong analytical, critical thinking, and problem solving skills, with sound judgement in complex or ambiguous risk scenarios.
- Demonstrate ability to influence, challenge, and drive alignment across functions, regions, and senior leadership levels while maintaining QA independence.
- Clear, concise, and inspection‑ready communication skills, both written and verbal.
- High level of accountability, integrity, and attention to detail, with ability to balance compliance rigor with business pragmatism.
- Strong capability in coaching, mentoring, and capability building, fostering a proactive quality and risk-aware culture.
- A globally aligned, inspection‑ready Quality Risk Management framework embedded within the Global QMS and consistently applied across R&D, Pharmacovigilance, Medical Affairs, and associated activities.
- Standardized, scalable quality risk management methodologies, tools, templates, and governance models that support proportional, science‑based, and risk‑based decision‑making.
- Clearly articulated and traceable quality risk assessments, risk registers, and mitigation plans, integrated with core QMS processes and enterprise risk management structures.
- Executive‑level risk insights, metrics, and trend analyses supporting Quality Management Review, senior leadership decision‑making, and continuous improvement.
- Digitally enabled QRM dashboards, analytics, and reporting that provide transparency, early risk detection, and sustained inspection readiness.
- Robust, inspection‑ready risk governance evidence supporting regulatory inspections, audits, and health authority interactions.
- Strengthened organizational capability and quality culture, demonstrated through consistent application of risk‑based principles, effective training, and proactive risk awareness across global stakeholders.
- Effective third‑party and vendor risk oversight, ensuring alignment between internal quality expectations and external partner practices.
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