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Job DescriptionPurpose:
- 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 Takeda's 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 Takeda’s 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.
- Open‑minded, appropriately risk‑tolerant, 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.
Skills Required
- Advanced degree such as MS, PharmD, PhD, MD, MBA, or equivalent in Life Sciences, Pharmacy, Chemistry, Biology, Engineering, Medicine, or a related scientific discipline.
- 15+ years of progressive experience in the biopharmaceutical, biotechnology, medical device, cell therapy, or related healthcare industry.
- 10+ years of leadership experience in Quality, Compliance, or Regulatory functions.
- Experience across multiple GxP disciplines, such as GCP, GMP, GLP, GVP, and/or Quality Management Systems.
- Proven experience leading enterprise-wide quality systems, 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 differences from FDA, EMA, and PMDA expectations.
- Strong interpersonal skills and executive presence, with the ability to influence and lead across organizational levels and external settings.
- Ability to prioritize effectively and lead under complexity and ambiguity.
- Integrity, ethical standards, commitment to patient safety, scientific rigor, and regulatory compliance.
Takeda Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Takeda and has not been reviewed or approved by Takeda.
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Retirement Support — Employer-funded retirement is described as notably strong, combining a dollar-for-dollar 401(k) match with an additional company contribution that scales with age and service. Access to an employee stock purchase plan further supports long-term wealth building.
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Parental & Family Support — Paid bonding leave for all parents, substantial adoption/surrogacy reimbursement, and robust caregiver resources (backup care and Maven family-forming support) are emphasized as core strengths. These offerings create a comprehensive safety net for a range of family situations.
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Healthcare Strength — Multiple medical plan options (nationwide PPO/HSA and regional HMOs), employer HSA funding, and integrated mental-health and well-being programs signal depth in coverage. Preventive care is covered in-network, and plan choices by state expand access.
Takeda Insights
What We Do
For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation, and as a future-focused organization, we’re continuing to drive forward with endurance in our steadfast pursuit to achieve the best outcomes for our patients in a rapidly changing world. We have been preparing for this period of value creation by investing in data, digital and technology, and we’re proud of our employees and their commitment to turning groundbreaking ideas into life-changing impacts. Since our founding in Japan, integrity and putting patients first have been at the heart of our identity, and we will emerge ready for our future as one of the most trusted and science-driven digital biopharmaceutical companies. Join a team where your innovation impacts lives. Together, we’ll realize improved outcomes by improving data quality, enhancing launch execution and improving the patient journey. You’ll play a critical role in accelerating data collection and increasing accuracy across all parts of the business. Patients across the globe will benefit from access to treatments afforded by greater opportunities and efficiency in our research and development.
Why Work With Us
We connect to our history and Japanese heritage through everything we do to bring our purpose, values, vision, and imperatives to life. We are committed to bringing better health and a brighter future to patients. Being a part of Takeda means having the opportunity to be a part of something bigger than yourself.
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