Assoc Dir, Clinical Pharmacovigilance and Medical Quality (CPMQ) Operations (Hybrid)

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Job Description

OBJECTIVES/PURPOSE:

• Advance strategic quality leadership by embedding global standards across Clinical Pharmacovigilance and Medical Quality (CPMQ) ensuring regulatory alignment and operational excellence.
• Drive innovation and transformation through organizational planning digitalization and capability buildingenhancing systems analytics and process efficiency across CPMQ and R&D.
• Strengthen quality oversight and risk management leading compliance strategies monitoring systems and continuous improvement initiatives that mitigate systemic risks and foster resilience.
• Serve as a strategic partner and change agent shaping clinical trial delivery transformations guiding GCP strategy and aligning quality initiatives with enterprise priorities and a culture of learning.

ACCOUNTABILITIES

• Identify and lead innovative transformation initiatives across CPMQ aligning with Takeda R&D and Global Quality objectives.
• Develop and execute strategic plans that enhance operational efficiency connectivity and digitalization across CPMQ and its stakeholders.
• Monitor CPMQ KPIs and performance trends intervening as needed and guiding future planning.
• Design and implement simplified end-to-end functional processes and tools aligned with global standards.
• Lead training development and delivery to support process and system implementation across CPMQ.
• Create and manage change management plans for new and revised CPMQ processes and systems.
• Analyze quality data to identify compliance risks maintain QMS dashboards and drive mitigation strategies.
• Organize and facilitate Clinical and Pharmacovigilance Quality council meetings including agenda and communications.
• Oversee CPMQ Risk Register and Quality Investigations escalating systemic risks and trends.
• Promote knowledge management and lessons learned frameworks to foster continuous improvement.
• Provide expert guidance on quality compliance and embed best practices across CPMQ teams.
• Act as QMS steward overseeing deviations serious breaches CAPAs SOPs audits inspections and training assignments.
• Provide support to GCP/GVP inspection activities including backroom operations and issue escalation.
• Oversee GxP-related contracts and invoice approvals ensuring alignment with quality standards.
• Drive digitalization and AI initiatives within CPMQ to enhance operational capabilities.
• Support CPMQ budget and resource planning in partnership with Finance ensuring global initiative funding.
• Maintain CPMQ playbook and communication platforms to ensure stakeholder awareness and alignment.

EDUCATION BEHAVIOURAL COMPETENCIES AND SKILLS:

• A BSc/BA degree. A degree in scientific or allied health/medical field preferred. An advanced degree on strategy innovation and leadership is an advantage.
• Minimum of 5 years of relevant experience. Experience can range from pharmaceutical R&D to project management strategy and innovation in a regulated environment.
• Strong foundational knowledge of quality and compliance is an advantage.
• Adaptive thinking and a strong critical mindset.
• Strong business acumen and presentation skills.
• Highly proficient at project planning budgeting and oversight.
• Strategic motivated forward-thinking and adaptable to dynamic situations.
• A solid understanding of innovation and how it should be applied in business.
• Excellent interpersonal leadership and communication skills.
• Has a track record of successful high-level interventions and projects which have resulted in long-term competitiveness within their organizations.

#GMSGQ #ZR1 #LI-MA1

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.

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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 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.

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Job Exempt