Head Digital Ethics & Compliance Global Manufacturing and Supply and Global Quality

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Job Description

Aboutthe role:

Digital Ethics & Compliance (DE&C) is part of Ethics & Compliance (E&C organization and focuses on what the organization needs by ensuring

• Ethical behavior plays a fundamental role in risk mitigation.

• Being a forward-thinking leader in risk identification and mitigation

• Building a modern function supporting achievement of Takeda’s Vision

E&C will respond rapidly to changing environment and business needs, it is close to the market, and encourages ethical behavior in line with Takeda’s values. By working in an agile manner, E&C ensures the balance between stable structures, governance, processes and systems, and dynamic approaches to delivering innovative solutions to appropriately manage our risks.

E&C commits to

• Act as role model for Takeda’s values, ethics and values-based decision making, fostering this mindset in clients, partners, and team.

• Enable the organization to take decisions which are ethical and in line with our priorities of Patient, Trust, Reputation, and Business

• Collaborate across all E&C teams and partner with Global Data & Technology (GD&T) stakeholders to embed ethics and compliance as part of the way everyone works at Takeda.

DE&C Team addresses digital, data and compliance risks by

• Providing a framework, Policies, SOPs and other tools that supports Business Units and Business functions like GMSGQ, including but not limited to GMSGQ Data, Digital & Technology (DD&T) organization to incorporate Ethics and Privacy by Design in their Data and Technology programs and platforms.

• Deploying the Global E&C Programs towards strengthening Takeda Ethical culture, Risk Management and Regulatory compliance.

• Acting as a E&C authority, trusted partner, and collaborator to ensure all Data & digital operations are compliant and ethical, while also leveraging the latest technologies to drive innovation and growth.

• Working with Business and DD&T to scale up digital technologies such as AI, ML, RWD and SaMD in an ethical and responsible manner.

How you will contribute:

Enabling

• Analyzes the impact of data and digital regulatory developments on GMSGQ Takeda’s business operations and compliance requirements (covering GMS/GQ and the GQ entreprise including but not limited to GQ R&D to LOC quality).

• Monitors and analyzes current and emerging local industry trends and identifies key drivers of change and assesses their potential impact on their organization.

• Stays up to date with evolving best practices and standards within the industry and ensures they align with industry benchmarks.

• Responsible for Governance oversight by establishing and overseeing governance structures, both vertically and horizontally.

• Executes global training and awareness initiatives on ethics, risk, and compliance topics within GMSGQ.

Partnering

Represent the DE&C value-generating front line business partnership by playing a key role closely interfacing with global Operating Units (Biologics, Small molecules, Plasma), region Japan, GMS above site functions (e.g. manufacturing sciences, Strategy & Business excellence where factories and functions of the future are being designed) responsible for:

• First point of contact within GMS and GQBU/BFs on matters related to DE&C by providing guidance to the business on compliance requirements, policies, procedures, risk methodology and activities.

• Link and Liaison between GMS and GQ and the Global Digital E&C teams.

• Deep understanding to support the business on the key areas of data and digital ethics and compliance such as data privacy, data ethics, AI ethics including technology ethics to enable sustainable and responsible innovation.

• Sits on the GMSGQ DD&T LT, GMSGQ EC LT, Global DE&C LT

• Collaborates with business on initial scanning of digital portfolio and support on continuous digital assets identification, registering, tracking and managing ethical and compliance risks.

• Ensure endorsement of Digital Ethics and Compliance Program within respective functions.

• Drives Digital Ethics, Risk and Compliance culture and awareness in GMSGQ.

• Facilitates implementation and maintenance of compliance risk management and controls processes.

• Ensures timely incidence reporting and compliance issues escalation.

• Provides guidance to the business function’s leadership on digital product strategy and development and ensures they align with digital ethical and compliance requirements.

• Conducts assessment on data and digital initiatives, impact analysis and assesses how they may impact on Takeda’s reputation and business strategies and feeds back the insights to enable teams.

• Designs and implements training materials with E&C teams, including e-learning modules, presentations, and manuals, and delivers formal and informal training programs to raise awareness of data and digital ethical and compliance standards within Takeda.

• Provides advisory support to GMSGQ DD&T teams on ethics and compliance matters, including regulatory requirements, industry standards, and internal policies.

• Assists teams in negotiations that involve contractual data provisions, Data Processing Agreements (DPAs), and Standard Contractual Clauses (SCCs).

Risks management

• Supports Risk Assessment processes by performing Initial risk profiling, performing assessment of compliance risks, coordinating continuous risk assessment with business and other risk functions along digital lifecycle.

• Supports elaboration of Risk Response strategy, treatment plan and procedures.

• Performs Risk and treatment Monitoring and reporting into the Risk Management system.

Capabilities

• Acts as role model for Takeda’s values, ethics and values-based decision making.

• Utilizes broad perspectives and knowledge to solve complex problems and to identify innovative solutions aligned with Takeda-ism (integrity, fairness, honest and perseverance) brought to life through decisions and actions that put the patient at the centre of everything we do, build trust with society, reinforce our reputation and develop a sustainable business, in that order.

• High interpersonal, communication and presentation skills including ability to challenge and provide guidance to business in a fair and objective manner.

• Demonstrates ability to deliver results through commitments made, tight schedules and project timelines.

• Communicates and engages others within the area of accountability to achieve objectives and align with interdependent areas

• Leading via influence and care, sometimes leading tough but fair conversations with limited/no authority.

• Ability to work with and comprehend significant detail and complexity in fast changing DE&C landscape.

• Personal and professional maturity, able to motivate and inspire others to live Takeda values in their day-to-day ways of working.

• Accountable for performance and results of complex projects.

• Facilitates an environment of organizational innovation, creates infrastructure to enable knowledge-sharing across employees, and participates in development of intellectual capita

• Receives guidance on complex/critical business situations

• Accountable for performance and results of complex projects

What you bring to Takeda:

• At least 15 years of professional experience, including 8 years of experience in ethics, risk, and compliance in progressively responsible positions with 4 years in the pharmaceutical industry, in diverse geographies.

• Bachelor’s degree, preferably in DD&T related field.

• Deep expertise in Ethics, Bioethics or Technology Ethics and Privacy

• Experience with Data Privacy (DP) controls implementation, Data/Digital Ethics risks management preferred.

• Experience in managing potential, present, and future ethics, compliance risks (Digital Compliance) related to Technology (Data Privacy, Tech Ethics, AI Ethics, Data Ethics), including risk identification, controls & risk mitigation of potential non-compliance.

• Experience with managing digital product risk and digital product lifecycle management.

• Experience with agile ways of working and mindset to enable Tech Ethics and responsible innovation via ethics by design, compliance by design in the tech landscape/platforms.

• Strong command of English language in both written and verbal form.

• Strong familiarity with and experience of all the elements of an ethics and compliance program (e.g., policies, risk management, learning, monitoring, case management)

• Strong business acumen and ability to build strong relationships with senior stakeholders.

• Experience with laws, regulations and industry guidance that affect the pharmaceutical industry including, but not limited to, IFPMA, EFPIA.

• Experience in using ethical decision-making methods for relevant business decisions.

• Ability to work independently and as part of very senior and complex teams within GMSGQ and beyond.

• High ethical standards and integrity.

• Relevant certifications in compliance and ethics are a plus.

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