Takeda Pharmaceuticals
Head of Medical Device & Software as Medical Device (SaMD)
Takeda Pharmaceuticals, Lexington, Massachusetts, United States, 02173
Quality Strategy Leader
Set and execute Takedas global quality strategy for medical devices, combination products, in vitro diagnostics (IVDs), and Software as a Medical Device (SaMD) across all business units, geographies, and therapeutic modalities spanning Takedas development pipeline and lifecycle management of marketed products. Drive inspection-ready and scalable, compliant, and patient-centric solutions across Takedas R&D and commercial portfolio.
Drive the design, implementation, and continuous improvement of operations and quality systems for medical device and digital health technologies, ensuring compliance with international regulatory requirements and Takeda Global procedures.
Lead and develop a global organization, fostering talent, accountability, and high performance to advance quality, ensure regulatory readiness, and drive innovation and operational excellence across the entire product lifecycle.
No. of direct reports : 7-10 No. of indirect reports : 25-30
Global Lead and oversee multiple functional areas including medical devices, combination products, in vitro diagnostics (IVDs), and Software as a Medical Device (SaMD), ensuring compliance with global quality standards.
Define and lead the global Quality strategy for medical devices, combination products, SaMD, and IVDs across all business units, geographies, and therapeutic modalitiesspanning Takedas development pipeline and lifecycle management of marketed products.
Provide senior-level Quality leadership and guidance across design, development, technology transfer, commercialization, and post-market surveillance.
Ensure global compliance with applicable medical device and software regulations (e.g., FDA 21 CFR Part 820, ISO 13485, ISO 14971, MDR / IVDR, MDSAP).
Act as or designate the Device Quality Management Representative (QMR) and Person Responsible for Regulatory Compliance (PRRC), where applicable.
Lead and develop a high-performing, globally distributed team, promoting clear accountability, performance management, and talent development.
Serve as a key Quality thought partner for senior stakeholders across R&D and Commercial to shape Takedas strategy in the combination product and digital health space.
Influence global policy development by participating in relevant industry forums and external regulatory dialogues.
Collaborate with Regulatory, Engineering, CMC, Safety, Commercial Quality, and Digital teams to support patient-centric innovation.
Champion quality system initiatives and inspection readiness efforts, including preparation and leadership during internal and external audits.
Establish and monitor performance indicators to ensure continuous improvement in device and software product quality.
Build strategies to support efficiencies and innovative solutions.
Demonstrated knowledge of global regulations and guidance governing medical device, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, MDR / IVDR, MDSAP, and global quality systems.
Strong background in software development life cycle, SaMD / SiMD validation, and quality oversight.
Ability to translate and articulate appropriate strategies and activities to ensure compliance to cGMP regulations and expectations.
A comprehensive understanding of pharmaceutical development, manufacturing, testing, and related technologies.
Demonstrated ability to lead and develop global teams, establish strategic priorities, and drive execution.
Proven track record of working with executive leadership and influencing decision-making across cross-functional stakeholders.
Highly effective communicator who establishes a compelling vision and encourages open dialogue across diverse viewpoints.
Holds employees accountable to deliver on expectations while embodying Takedas values and priorities.
Promotes growth through development opportunities, mentoring, and support for career advancement.
Acts as a role model for taking smart, compliant risks that advance innovation.
Makes high-impact decisions with accountability for results and alignment with Takedas quality, compliance, and business objectives.
Applies structured risk-based thinking to address challenges and identify sustainable solutions.
Makes risk-based decisions on quality issues and product disposition, ensuring patient safety and cGMP compliance.
Analyzes complex data and applies judgment to make timely decisions, even with limited information.
Empowers hiring and resource decisions within budget and organizational guidelines.
Has flexible and creative problem-solving skills.
Work within complex organizations and across functions, at all levels where the incumbent may not have direct authority.
Builds and maintains strong relationships with internal teams, global stakeholders, external partners, and regulatory bodies.
Leads with clarity and poise in high-pressure or ambiguous situations.
Manages long-term strategic efforts while balancing short-term operational demands.
Collaborates across Takedas network and serves as a trusted partner in executive-level interactions.
Drives improvement through innovation, promotes digital thinking, and fosters adoption of next-gen quality capabilities.
Encourages continuous learning and experimentation within the quality organization.
Oversees a complex and diverse portfolio of productsincluding devices, SaMD, IVDs, and combination productsspanning multiple geographies, business units, therapeutic modalities, and evolving global regulatory landscapes.
Navigates complex stakeholder environments, competing priorities, and evolving global regulations.
Leads enterprise-level quality initiatives that address broad strategic needs.
Develops solutions to complex Quality issues which potentially impact patient safety and compliance.
Minimum requirements : Advanced degree in engineering, life sciences, or related field (B.S. required; M.S. / Ph.D. preferred).
Minimum 10 years of industry experience, including 5 years in medical device and / or combination product quality.
At least 5+ years of direct leadership and team management experience.
In-depth knowledge of global medical device and SaMD regulations (FDA, ISO 13485, ISO 14971, MDR / IVDR, MDSAP).
Proven experience supporting regulatory inspections and driving quality excellence in regulated environments.
Preferred requirements : Experience working in global matrix organizations and leading cross-cultural teams.
Familiarity with emerging digital health technologies, agile development practices, and AI / ML-enabled medical devices.
Experience with both development and commercial-stage product support, including lifecycle management and sustaining engineering.
#J-18808-Ljbffr
Set and execute Takedas global quality strategy for medical devices, combination products, in vitro diagnostics (IVDs), and Software as a Medical Device (SaMD) across all business units, geographies, and therapeutic modalities spanning Takedas development pipeline and lifecycle management of marketed products. Drive inspection-ready and scalable, compliant, and patient-centric solutions across Takedas R&D and commercial portfolio.
Drive the design, implementation, and continuous improvement of operations and quality systems for medical device and digital health technologies, ensuring compliance with international regulatory requirements and Takeda Global procedures.
Lead and develop a global organization, fostering talent, accountability, and high performance to advance quality, ensure regulatory readiness, and drive innovation and operational excellence across the entire product lifecycle.
No. of direct reports : 7-10 No. of indirect reports : 25-30
Global Lead and oversee multiple functional areas including medical devices, combination products, in vitro diagnostics (IVDs), and Software as a Medical Device (SaMD), ensuring compliance with global quality standards.
Define and lead the global Quality strategy for medical devices, combination products, SaMD, and IVDs across all business units, geographies, and therapeutic modalitiesspanning Takedas development pipeline and lifecycle management of marketed products.
Provide senior-level Quality leadership and guidance across design, development, technology transfer, commercialization, and post-market surveillance.
Ensure global compliance with applicable medical device and software regulations (e.g., FDA 21 CFR Part 820, ISO 13485, ISO 14971, MDR / IVDR, MDSAP).
Act as or designate the Device Quality Management Representative (QMR) and Person Responsible for Regulatory Compliance (PRRC), where applicable.
Lead and develop a high-performing, globally distributed team, promoting clear accountability, performance management, and talent development.
Serve as a key Quality thought partner for senior stakeholders across R&D and Commercial to shape Takedas strategy in the combination product and digital health space.
Influence global policy development by participating in relevant industry forums and external regulatory dialogues.
Collaborate with Regulatory, Engineering, CMC, Safety, Commercial Quality, and Digital teams to support patient-centric innovation.
Champion quality system initiatives and inspection readiness efforts, including preparation and leadership during internal and external audits.
Establish and monitor performance indicators to ensure continuous improvement in device and software product quality.
Build strategies to support efficiencies and innovative solutions.
Demonstrated knowledge of global regulations and guidance governing medical device, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, MDR / IVDR, MDSAP, and global quality systems.
Strong background in software development life cycle, SaMD / SiMD validation, and quality oversight.
Ability to translate and articulate appropriate strategies and activities to ensure compliance to cGMP regulations and expectations.
A comprehensive understanding of pharmaceutical development, manufacturing, testing, and related technologies.
Demonstrated ability to lead and develop global teams, establish strategic priorities, and drive execution.
Proven track record of working with executive leadership and influencing decision-making across cross-functional stakeholders.
Highly effective communicator who establishes a compelling vision and encourages open dialogue across diverse viewpoints.
Holds employees accountable to deliver on expectations while embodying Takedas values and priorities.
Promotes growth through development opportunities, mentoring, and support for career advancement.
Acts as a role model for taking smart, compliant risks that advance innovation.
Makes high-impact decisions with accountability for results and alignment with Takedas quality, compliance, and business objectives.
Applies structured risk-based thinking to address challenges and identify sustainable solutions.
Makes risk-based decisions on quality issues and product disposition, ensuring patient safety and cGMP compliance.
Analyzes complex data and applies judgment to make timely decisions, even with limited information.
Empowers hiring and resource decisions within budget and organizational guidelines.
Has flexible and creative problem-solving skills.
Work within complex organizations and across functions, at all levels where the incumbent may not have direct authority.
Builds and maintains strong relationships with internal teams, global stakeholders, external partners, and regulatory bodies.
Leads with clarity and poise in high-pressure or ambiguous situations.
Manages long-term strategic efforts while balancing short-term operational demands.
Collaborates across Takedas network and serves as a trusted partner in executive-level interactions.
Drives improvement through innovation, promotes digital thinking, and fosters adoption of next-gen quality capabilities.
Encourages continuous learning and experimentation within the quality organization.
Oversees a complex and diverse portfolio of productsincluding devices, SaMD, IVDs, and combination productsspanning multiple geographies, business units, therapeutic modalities, and evolving global regulatory landscapes.
Navigates complex stakeholder environments, competing priorities, and evolving global regulations.
Leads enterprise-level quality initiatives that address broad strategic needs.
Develops solutions to complex Quality issues which potentially impact patient safety and compliance.
Minimum requirements : Advanced degree in engineering, life sciences, or related field (B.S. required; M.S. / Ph.D. preferred).
Minimum 10 years of industry experience, including 5 years in medical device and / or combination product quality.
At least 5+ years of direct leadership and team management experience.
In-depth knowledge of global medical device and SaMD regulations (FDA, ISO 13485, ISO 14971, MDR / IVDR, MDSAP).
Proven experience supporting regulatory inspections and driving quality excellence in regulated environments.
Preferred requirements : Experience working in global matrix organizations and leading cross-cultural teams.
Familiarity with emerging digital health technologies, agile development practices, and AI / ML-enabled medical devices.
Experience with both development and commercial-stage product support, including lifecycle management and sustaining engineering.
#J-18808-Ljbffr