Head, R&D Quality, Asia

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Purpose:

• The Head of R&D Quality Asia is the senior Quality executive responsible for providing strategic leadership oversight and governance across the full spectrum of GxP R&D Quality activities within the region. This role is accountable for ensuring quality compliance data integrity and inspection readiness across the entire R&D portfolio from early-stage research through clinical development and commercialization.

• This leader establishes and drives a forward-looking regional quality strategy aligned with Takedas Global Quality and R&D objectives ensuring consistent application of quality standards risk management principles and regulatory requirements across both China-specific and global regulatory frameworks (e.g. NMPA FDA EMA PMDA) proactively navigating differences in nonclinical and clinical expectations to support Takedas regional and global development strategies.

• As a member of the Global R&D Quality Leadership Team the role partners closely with global and regional senior leaders external partners and regulatory agencies to advance business priorities while maintaining the highest standards of quality and compliance.

Scope:

• Lead R&D Quality Functions within Asia specifically GMP GLP GCP GVP and QCSD with accountability for quality oversight supporting the entire R&D portfolio from early research through commercialization readiness.

• Member of the Global R&D Quality Leadership Team and R&D China and APAC Regional Leadership Teams

• Significant interaction with global senior leadership external partners and health authorities / regulatory agencies.

• Responsible for regional budget resource allocation organizational effectiveness succession planning and talent strategy.

Accountabilities:

• Develop and execute the Asia R&D Quality strategy ensuring alignment with Global R&D Quality and regional business objectives.

• Build strong strategic partnerships with all functions within R&D Asia to embed quality throughout the product lifecycle and be a strategic partner to senior leaders on quality compliance regulatory inspection and business risks.

• Accountable for R&D Quality systems compliance and governance across the Asia region ensuring all activities are conducted in accordance with global regulatory requirements Takeda standards and established quality expectations.

• Lead quality risk management and Quality Management System (QMS) execution across R&D Asia including audits inspections CAPAs deviations change control training document management governance forums and performance monitoring to identify assess and mitigate enterprise quality and compliance risks.

• For R&D Asia oversee data integrity computerized systems validation (CSV) software development lifecycle (SDLC) digital platforms and the use of analytics to enable data-driven quality decisions.

• Accountable for inspection and audit readiness across the region representing R&D Quality during health authority inspections and driving effective responses remediation and sustainable compliance improvements.

• Ensure quality oversight and compliance by interpreting and harmonizing China-specific regulatory requirements with ex-China expectations enabling consistent risk-based quality approaches for nonclinical studies nonclinical testing and clinical trial activities conducted within the region.

• Provide strategic oversight of supplier and partner quality programs including CROs CMOs laboratories and other critical vendors ensuring effective risk-based monitoring and compliance.

• Represent R&D Quality supporting regional external opportunities/partnerships due-diligence

• Lead develop and inspire a high-performing regional Quality organization through talent development succession planning organizational effectiveness resource management and a culture of quality integrity accountability and continuous improvement

Qualifications:

• Advanced degree (MS PharmD PhD MD MBA or equivalent) in Life Sciences Pharmacy Chemistry Biology Engineering Medicine or related scientific discipline.

• 15 years of progressive experience within the biopharmaceutical biotechnology medical device cell therapy or related healthcare industry.

• 10 years of leadership experience in Quality Compliance Regulatory preferably across multiple GxP disciplines such as GCP GMP GLP GVP and / or Quality Management Systems.

• Proven track record in global strategic quality roles leading enterprise-wide quality systems hosting audits and regulatory inspections complex investigations and remediation and large-scale business transformation initiatives.

• Deep understanding of China NMPA regulatory requirements for nonclinical and clinical development including awareness of regulatory expectations that differ from FDA/EMA/PMDA (e.g. legacy nonclinical study requirements) and ability to guide teams through these differences.

• Strong interpersonal skills and executive presence with the ability to influence align and lead effectively across all organizational levels and represent the organization and function in diverse global and external settings.

• Decisive proactive and highly organized with the ability to prioritize effectively and lead under complexity and ambiguity.

• Openminded appropriately risktolerant and resilient demonstrating humility openness to challenge and constructive debate.

• Unwavering integrity and ethical standards with a strong commitment to patient safety scientific rigor and regulatory compliance.