Associate Director - QMS Lifecycle Management (R&D)

About the role

The Associate Director, QMS Lifecycle Management (R&D Focus) serves as the R&D business partner within the Lifecycle Management pillar of the Quality Management System (QMS). This role supports the integrity and evolution of the QMS process framework for R&D-relevant processes by partnering with Global Process Owners (GPOs) and key stakeholders to implement standards, governance, and metrics.

Responsibilities

• Partner with and support teams and leaders of Global Process Owners (GPOs) for R&D-relevant processes within the Lifecycle Management pillar, including Drug & Device Development, Non-Clinical/Discovery Programs, Clinical Management (including trial design, site engagement, data analysis, and disclosure of research results), Global Patient Safety, and Regulatory affairs according to the QMS global process framework.
• Governance & Strategy:
• Execute within QMS governance and monitoring models for the Lifecycle Management pillar, representing R&D needs and ensuring alignment to the global process framework.
• Partner with the Operational Controls Lead and process owners to define, monitor, and interpret health measures for the R&D-relevant QMS process ecosystem (e.g., performance, compliance, effectiveness, and user experience indicators).
• Support adherence to applicable global regulatory standards and internal requirements for R&D processes; identify gaps and escalate compliance risks, trends, and remediation needs through established governance forums.
• Continuous Improvement:
• Identify and support process improvement opportunities for R&D-relevant Lifecycle Management processes by analyzing process performance, deviations, findings, and stakeholder feedback.
• Monitor and summarize key metrics and leading indicators; provide routine reporting and actionable recommendations to GPOs, R&D stakeholders, and the Operational Controls Lead.
• Leadership, Collaboration & Stakeholder Engagement:
• Build and sustain strong working relationships with GPOs and the R&D stakeholder community to coordinate process updates, communications, training alignment, and adoption support.
• Collaborate with enterprise and functional teams to ensure R&D needs are represented in standardized global business processes and QMS documentation.
• Maintain awareness of relevant regulatory and industry trends affecting R&D quality processes and share implications with stakeholders; coordinate interpretation and actions through the Operational Controls Lead and appropriate governance bodies.
• Build and maintain an inventory of R&D stakeholders, including functional leads.
• Identify and engage primary, secondary, and informed stakeholders for each process, ensuring robust communication, strategic document management, training, and delivery planning.
• Collaborate with R&D teams to ensure processes are fit-for-purpose and support innovation, scientific rigor, compliance, and increased value of Quality.

Requirements

• 7+ years’ experience in the pharmaceutical industry in business, quality, or operational roles, with demonstrated understanding of research and development processes and/or clinical operations.
• Bachelor’s degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field.

Qualifications

• Proven ability to work in a matrixed organization leading diverse teams and influencing areas not under direct control, especially in R&D environments.
• Experience supporting cross-functional or multi-site process improvement initiatives in R&D.
• Strong strategic thinking capability with a focus on executing strategic decisions while balancing conflicting priorities in research and development.
• Ability to drive process improvements and strategic decisions by analyzing and interpreting complex R&D data.
• Demonstrated change agility in anticipating and leading others through change and ambiguity in scientific and regulatory contexts.
• Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate at all levels through various formats.
• Expertise in developing scalable and standardized processes across global R&D operations to improve efficiency and reduce complexity.
• Demonstrated ability to influence and partner effectively with R&D functional leads and process owners.
• Demonstrated ability to balance speed, quality, and risk and to recommend actions that deliver value-added results.
• Strong capabilities in establishing governance structures and proactively addressing quality and regulatory risks in research and development.
• Demonstrated ability to lead through influence in a matrixed environment.
• Expertise in navigating and ensuring adherence to global regulatory standards and frameworks relevant to R&D.
• Available to travel (domestic and international) when required (ca. 10%).