Assoc Dir, Clinical Pharmacovigilance and Medical Quality (CPMQ) Operations (Hybrid)
Takeda
1 month ago
Remote friendly (Boston, MA)
United States
$154,400 - $242,550 USD yearly
Operations
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 building—enhancing 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
- Lead transformation initiatives across CPMQ aligned with Takeda R&D and Global Quality objectives.
- Develop and execute strategic plans to improve operational efficiency, connectivity, and digitalization across CPMQ and stakeholders.
- Monitor CPMQ KPIs and performance trends; intervene as needed to guide future planning.
- Design and implement simplified, end-to-end processes and tools aligned with global standards.
- Develop and deliver training to support process and system implementation across CPMQ.
- Create and manage change management plans for new/revised CPMQ processes and systems.
- Analyze quality data to identify compliance risks; maintain QMS dashboards and mitigation strategies.
- Facilitate Clinical and Pharmacovigilance Quality council meetings (agenda and communications).
- Oversee CPMQ Risk Register and Quality Investigations; escalate systemic risks and trends.
- Promote knowledge management and lessons learned frameworks for 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.
- Support GCP/GVP inspection activities (backroom operations and issue escalation).
- Oversee GxP-related contracts and invoice approvals aligned with quality standards.
- Drive CPMQ digitalization and AI initiatives to enhance operational capabilities.
- Support CPMQ budget and resource planning with Finance for global initiative funding.
- Maintain CPMQ playbook and communication platforms for stakeholder awareness and alignment.
EDUCATION & SKILLS (REQUIRED/PREFERRED)
- BSc/BA degree. Degree in scientific or allied health/medical field preferred. Advanced degree in strategy/innovation/leadership is an advantage.
- Minimum 5 years relevant experience (pharmaceutical R&D to project management/strategy/innovation in a regulated environment).
- Strong foundational knowledge of quality and compliance (advantage).
- Adaptive thinking and critical mindset.
- Strong business acumen and presentation skills; excellent interpersonal/leadership/communication skills.
- Highly proficient in project planning, budgeting, and oversight.
- Strategic, motivated, forward-thinking, adaptable to dynamic situations.
- Solid understanding of innovation and how to apply it in business.
- Track record of successful high-level interventions/projects resulting in long-term competitiveness.
COMPENSATION & BENEFITS (as stated)
- U.S. Base Salary Range: $154,400.00 - $242,550.00 (Boston, MA).
- May be eligible for short-term and/or long-term incentives.
- Medical, dental, vision, 401(k) match, disability, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits.
- Up to 80 hours sick time/year; new hires accrue up to 120 hours paid vacation.
APPLICATION INSTRUCTION
- By clicking the “Apply” button, the employment application process commences and application information will be processed per Takeda’s Privacy Notice and Terms of Use.
- 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 building—enhancing 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
- Lead transformation initiatives across CPMQ aligned with Takeda R&D and Global Quality objectives.
- Develop and execute strategic plans to improve operational efficiency, connectivity, and digitalization across CPMQ and stakeholders.
- Monitor CPMQ KPIs and performance trends; intervene as needed to guide future planning.
- Design and implement simplified, end-to-end processes and tools aligned with global standards.
- Develop and deliver training to support process and system implementation across CPMQ.
- Create and manage change management plans for new/revised CPMQ processes and systems.
- Analyze quality data to identify compliance risks; maintain QMS dashboards and mitigation strategies.
- Facilitate Clinical and Pharmacovigilance Quality council meetings (agenda and communications).
- Oversee CPMQ Risk Register and Quality Investigations; escalate systemic risks and trends.
- Promote knowledge management and lessons learned frameworks for 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.
- Support GCP/GVP inspection activities (backroom operations and issue escalation).
- Oversee GxP-related contracts and invoice approvals aligned with quality standards.
- Drive CPMQ digitalization and AI initiatives to enhance operational capabilities.
- Support CPMQ budget and resource planning with Finance for global initiative funding.
- Maintain CPMQ playbook and communication platforms for stakeholder awareness and alignment.
EDUCATION & SKILLS (REQUIRED/PREFERRED)
- BSc/BA degree. Degree in scientific or allied health/medical field preferred. Advanced degree in strategy/innovation/leadership is an advantage.
- Minimum 5 years relevant experience (pharmaceutical R&D to project management/strategy/innovation in a regulated environment).
- Strong foundational knowledge of quality and compliance (advantage).
- Adaptive thinking and critical mindset.
- Strong business acumen and presentation skills; excellent interpersonal/leadership/communication skills.
- Highly proficient in project planning, budgeting, and oversight.
- Strategic, motivated, forward-thinking, adaptable to dynamic situations.
- Solid understanding of innovation and how to apply it in business.
- Track record of successful high-level interventions/projects resulting in long-term competitiveness.
COMPENSATION & BENEFITS (as stated)
- U.S. Base Salary Range: $154,400.00 - $242,550.00 (Boston, MA).
- May be eligible for short-term and/or long-term incentives.
- Medical, dental, vision, 401(k) match, disability, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits.
- Up to 80 hours sick time/year; new hires accrue up to 120 hours paid vacation.
APPLICATION INSTRUCTION
- By clicking the “Apply” button, the employment application process commences and application information will be processed per Takeda’s Privacy Notice and Terms of Use.