Head, Clinical and Safety Quality Compliance (Hybrid)

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Job Title: Head, Clinical and Safety Quality Compliance

Location: Cambridge, MA or Zurich, Switzerland

• Leads the global Clinical, Pharmacovigilance, and Medical Quality Compliance organization, providing quality oversight of the quality systems supporting Takeda’s clinical research (GCP), pharmacovigilance (GVP) and medical activities across the enterprise and ensuring that it’s robust, aligned with and compliant to applicable regulatory requirements, and governed and  positioned for continual improvement.

• Establishes the quality oversight of Takeda’s licensing partners, and vendors and suppliers who are engaged to provide regulated clinical research (GCP), pharmacovigilance (GVP) and medical services. This includes a risk-based qualification and audit program, quality agreements and governance.

• Serves as a senior strategic Quality Partner to various Compliance functions in Data Science Institute (DSI), Global Development Operations (GDO) and Global Regulatory Affairs (GRA).

• Reports to the Head of CPMQ and is a key member of the CPMQ Leadership Team, contributing to the design, implementation and advancement of the CPMQ strategy, model and operations.

• Leads the CPMQ Compliance function in the development, implementation and refinement of a proactive and risk-based quality operating model for Takeda’s clinical research (GCP), pharmacovigilance (GVP) and medical activities across the enterprise and  Takeda’s licensing partners, vendors and suppliers.

• Ensures a robust framework for the quality oversight, review and approval of Quality Management System (QMS) standards and procedures for regulated activities in Clinical Research (GCP), Pharmacovigilance (GVP) and Medical. Actively participate in quality system improvement initiatives and programs, championing risk-based methodologies and compliance.

• Oversees and provides the strategy and framework for clinical and pharmacovigilance inspections, ensuring readiness is embedded in the processes, hosting and management of inspections are adequately resourced by experts. Ensures that inspection risks and findings are reported, escalated and adequately mitigated in a timely manner.

• Executes foundational quality systems activities (e.g., change control, deviations and investigations, incident notification and escalation, CAPA, etc) for Clinical Research, Pharmacovigilance and Medical are effective and appropriately resourced and supported.

• Manages the Clinical & Safety Quality Council, communicating any quality or compliance risks and opportunities and ensuring relevant R&D management are well-informed to make decisions on quality and compliance priorities. Contributes to other functional Compliance meetings, as needed.

• Provides strategic direction in the development and monitoring of relevant Key Quality Indicators (KQI) and metrics, data trending and insights. Mitigates, communicates, and escalates any risks flagged by the metrics and KQIs, ensuring actions are commensurate to the risk and timely.

• In collaboration with Quality Compliance & Systems, provides direction and subject matter expertise in the internal audit program of the clinical research (GCP), pharmacovigilance (GVP) and medical processes and systems across the enterprise.

• Sets the strategy, and leads the development and execution of a risk-based audit program for the global business (licensing) partners, vendors and suppliers.

• Ensures that the appropriate Quality Agreements are in place, and that Takeda quality governance (e.g., Quality Management Working Group, etc.) are conducted effectively and any critical compliance risks are discussed, mitigated and reported with Takeda management.

• Ensures robust talent development and succession planning measures are in place to promote organizational growth/elevate capabilities.

• Ensures there is a framework for knowledge management.

• Establishes avenues for Quality advocacy and governance.

• Scientific or allied health/medical degree (BSc). Masters/PhD preferred.

• Minimum of 15 years of increasing responsibility and relevant experience in the global pharmaceutical industry, preferably with at least 5 years of Quality/Compliance experience.

• Advanced knowledge of clinical research (GCP), pharmacovigilance (GVP) and medical throughout R&D and commercialization, and relevant regulations.

• Preferably with experience in strategic roles involving quality systems and clinical portfolio oversight, large-scale audit programs, regulatory inspection management, investigation and remediation activities on a global level and successful management of business transformation/change management initiatives e.g., quality system integration, outsourcing strategy, etc.

• Fluency in written and spoken English, additional language skills a plus.

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.

• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

• Work in a cold, wet environment.

• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.