Associate Director, R&D Quality Compliance and Metrics

Takeda • Lexington, MA

2d

About The Position

Objective / Purpose: The Associate Director of R&D Quality Compliance and Metrics provides centralized leadership and expertise across R&D functions to drive the integration and oversight of KPIs, metrics reporting, and periodic review. This role is responsible for oversight of several key compliance workstreams in R&D Quality and partners with RDQ functional leads for successful execution. The Associate Director contributes to organizational success through strong individual leadership, collaboration, and fostering a culture of compliance and continuous improvement.

Requirements

• Minimum requirements: Bachelor’s Degree in Chemistry, Biology, Engineering or related field
• 10+ years of increasing responsibility and experience in the biopharma/biotech industry
• 8+ years of Quality/Compliance experience
• In-depth knowledge of global regulations governing biopharmaceutical research & development as well as the role of Quality Management Systems, with the ability to effectively translate and articulate strategies to ensure compliance.
• Knowledge and understanding of the use of data visualization and analytics to monitor performance, drive improvements, and enable data-driven decision making.
• Proven leadership, collaboration, and influencing skills, coupled with a demonstrated ability to solve problems and drive impactful change.
• Proficiency in working with diverse individuals across all organizational levels.
• Exceptional interpersonal, verbal, and written communication skills, enabling successful interaction with stakeholders across the enterprise.
• Adaptability and flexibility to thrive in dynamic environments, along with the ability to manage and deliver multiple projects on time.
• Strong attention to detail and organizational expertise, with a capacity to work independently across global settings, navigate organizational complexities, and influence without authority.

Nice To Haves

• Advanced degree in Chemistry, Biology, Engineering or related field
• Prior people-management experience

Responsibilities

• Serve as the R&D strategy leader to design, socialize, and implement a Quality Compliance Maturity Model, ensuring alignment with enterprise quality objectives and regulatory expectations.
• Design and establish an agile operating model for Quality Councils that harmonizes governance processes and enables proactive, cross-functional management and decision-making.
• In collaboration with the data and digital quality team, establish R&D enterprise level tools to monitor and automate quality metrics enabling acceleration of risk management
• Develop and maintain a comprehensive Quality metrics framework in accordance with Global standards, extending measurement to critical R&D indicators across relevant functions.
• Partner with Quality functions to oversee the standardized Quality Council process, and engage local organizations to validate governance outcomes, confirm action effectiveness, and drive timely follow-through.
• Lead organizational analysis and review of external supplier compliance/quality performance, consolidating data from across the R&D Quality functions to present a holistic data-driven view of risks and areas of heightened focus.
• Ensure compliant and timely conduct of audits, reporting, and follow-up per global and local procedures.
• Serve as R&D Quality lead to ensure oversight and compliance with Takeda records management requirements across the organization.
• Partner with Global Quality Compliance and Systems to align on strategies for revisions to global processes, represent R&D Quality interests, and ensure connectivity of R&D Quality SMEs to GQ workstreams where needed and pro-actively manage changes to metrics as required
• Partner with R&D Quality leaders and functions lead change management strategies and support the evolution of new ways of working, in alignment with desired organizational goals.
• Support the development and implementation of multi-year organizational strategy for the R&D Quality Compliance, Systems, and Data organization.
• Undertake additional duties as assigned in order to contribute to the overall success of the organization.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees