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Job Description

OBJECTIVES:

• Provides strategic quality oversight to strategic suppliers, ensuring that the appropriate Quality Agreements are in place and that quality governance are conducted effectively and any critical compliance risks are discussed, mitigated and reported with Takeda management.

• Serves as the strategic Quality thought partner to Procurement and relevant clinical, pharmacovigilance and medical functions responsible for the engagement and oversight of strategic suppliers.

• Reports to the Head of CPMQ Partnership Quality, contributing to the design, implementation and advancement of the Partnership Quality strategy, model and operations.

ACCOUNTABILITIES:

• In collaboration with the Head of Partnership Quality, develops, implements, and refines a proactive and risk-based quality oversight and management strategy of Takeda’s strategic suppliers who are engaged to provide/conduct regulated clinical, pharmacovigilance and medical services and/or activities.

• Ensures that the appropriate Quality Agreements are in place for strategic suppliers and that Takeda quality governance is conducted effectively and any critical compliance risks are discussed, mitigated and reported with Takeda management.

• Provides strategic input to the development and implementation of the risk-based audit strategy for these strategic suppliers.

• Establishes an effective mechanism to monitor compliance, issue and risk management of strategic supplier, ensuring that appropriate controls, reporting and escalations are facilitating timely mitigations.

• In partnership with the strategic suppliers, develops and monitors relevant metrics and Key Performance/Quality Indicators (KPI/KQI) for the services provided by strategic suppliers conducting clinical research and/or pharmacovigilance. Mitigates, communicates, and escalates any risks flagged by the metrics and KPIs/KQIs, ensuring actions are commensurate to the risk and timely.

• Performs an analysis and synthesis of information provided by strategic suppliers, including metrics, KPI/KQIs, to provide strategic direction in the management of supplier activities including contract and service negotiations and discussions, functional oversight, audits, etc.

• Leads and/or participates in governance/quality councils relevant to strategic supplier activities.

• Contributes to any relevant internal quality and compliance governance (e.g., Clinical & Safety Quality Council), communicating any quality or compliance risks and opportunities, continual improvements and successes.

• Participate in GCP health authority inspections as required. Notifies strategic suppliers of inspections and audits and liaises with them for any inspection or audit requests. Communicates any relevant inspection and audit findings, and ensures that these findings are adequately responded, addressed, and resolved in a timely manner, and followed up in succeeding supplier audits.

• Partners within CPMQ, Procurement and other R&D functions to ensure alignment on both quality and business objectives. Reports on relevant trends providing these functions with actionable insights from interactions with strategic suppliers.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• BS/BA degree required; advanced degree preferred

• Expert knowledge of GCP and understanding of global clinical development

• Minimum 7 years of industry experience preferably in Clinical Development. Supplier oversight experience preferred.

• Minimum 5 years of managerial experience

• Experience working within complex organizations, working closely with senior staff and executive level colleagues. Ability to handle confidential, complex situations and multiple responsibilities, simultaneously mixing long term projects with the urgency of immediate demands on the operations.

• Possess outstanding leadership and interpersonal skills with a management style which encourages open expressions of ideas, opinions, and a full discussion of differing points of view. Sound judgment and independent initiative.

• Demonstrated ability to collaborate with and achieve results through others, the ability to build strong and sustainable relationships and the capability to interact within all levels of the organization.

• Demonstrated ability to succinctly translate and effectively communicate the potential impact of significant and complex issues.

• Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents. Ability to effectively present information to top management, internal groups, external partners and customers.

• Ability to manage assignments and effectively deliver all expected deliverables in an organized and a timely manner and proactively communicate changes in pre-established goals and deadlines.

LICENSES/CERTIFICATIONS:

• GCP and Quality Assurance registration/certification preferred

PHYSICAL DEMANDS:

• Routine demands of an office-based environment

TRAVEL REQUIREMENTS:

• Willingness to travel to various meetings and/or audits, including overnight trips. Some international travel may be required.

• Requires approximately 30% travel.

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:

Boston, MA

U.S. Base Salary Range:

$149,100.00 - $234,300.00

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-term incentives. 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.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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