Job Description

Assoc Dir, Clinical Pharmacovigilance and Medical Quality (CPMQ) Operations Takeda is seeking an experienced leader to advance global quality standards across Clinical, Pharmacovigilance, and Medical Quality (CPMQ) functions. The role leads strategic planning, digital transformation, risk management, and compliance initiatives to support regulatory alignment and operational excellence. Job Description Objectives / Purpose Embed global standards across CPMQ, ensuring regulatory alignment and operational excellence. Drive innovation through organizational planning, digitalization, and capability building, enhancing systems, analytics, and process efficiency. Strengthen quality oversight and risk management by leading compliance strategies, monitoring systems, and continuous improvement initiatives. Act as a strategic partner and change agent, shaping clinical trial delivery transformations and guiding GCP strategy. Accountabilities Lead innovative transformation initiatives aligned with Takeda R&D and Global Quality objectives. Develop and execute strategic plans to enhance operational efficiency, connectivity, and digitalization across CPMQ. 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 back‑room 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. Maintain CPMQ playbook and communication platforms to ensure stakeholder awareness and alignment. Education, Behavioral Competencies and Skills A BSc/BA degree (scientific, allied health, or medical field preferred). An advanced degree in strategy, innovation or leadership is an advantage. Minimum of 5 years of relevant experience in pharmaceutical R&D, project management, strategy, or innovation within a regulated environment. Strong foundational knowledge of quality and compliance. Adaptive thinking, strong critical mindset, and solid business acumen. Excellent interpersonal, leadership, and communication skills. Highly proficient at project planning, budgeting, and oversight. Strategic, motivated, forward‑thinking and adaptable to dynamic situations. Track record of successful high‑level interventions and projects yielding long‑term competitiveness. Location Boston, MA Compensation $153,600.00 – $241,340.00 per year (U.S. base salary range) Benefits Summary U.S. based employees may be eligible for short‑term and/or long‑term incentives, medical, dental, vision insurance, 401(k) plan with company match, disability coverage, life insurance, tuition reimbursement, paid volunteer time off, company holidays, well‑being benefits, sick time (up to 80 hours per year) and paid vacation (up to 120 hours for new hires). Compensation is based on qualifications, experience, location, and other factors. EEO Statement Takeda is proud of 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, marital status, veteran status, or other characteristics protected by law. #J-18808-Ljbffr Takeda

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