Senior Director, Audits, Inspections, & QMS

Role Summary

The Senior Director of Quality Analytics and Automation leads the Quality organization in advancing data, metrics, automation, and AI to enable insight-driven decision-making and improve operational efficiency across the GxP landscape. This role builds scalable reporting capabilities, enhances Quality’s digital roadmap, and identifies technology-enabled opportunities to modernize core processes. The role owns day-to-day execution for Quality systems (e.g., Veeva Vault Quality, DocuSign, analytics dashboards) and leads data integrity initiatives to improve data quality and standards. It requires partnering with Quality, Technical Operations, IT, and other stakeholders to deliver data-enabled solutions; this position can be remote, hybrid, or onsite in Cambridge, MA, with a preference for a US-based colleague frequenting Cambridge.

Responsibilities

• Lead the development and deployment of performance dashboards and analytic frameworks that support enterprise visibility, regulatory compliance and readiness, and strategic planning.
• Collect, analyze, and implement business requirements and objectives into tech-driven solutions and effective system configurations that optimize user needs and compliance requirements
• Design and implement data structures that support business insights, reporting capabilities, and system integrations
• Drive the identification and implementation of automation and digital enablement of Quality processes, including low-code/no-code solutions, structured workflows, and system integrations.
• Provide guidance and leadership on Quality data model development, harmonization, and visualization strategies.
• Collaborate across Quality and key business stakeholders to identify cross-functional compliance trends and performance signals, with a focus on enabling data-driven insights.
• Drive quality data literacy and the advancement of the automation roadmap, including future-state capabilities in predictive insights and operational intelligence.
• Partner with the Quality Strategy & Operations (QSO) team to support data-driven risk identification, trending, and visualization across Quality governance forums and enterprise initiatives
• Support the adoption and implementation of digital tools across the Quality organization; develop resources and training to strengthen digital fluency and promote self-service analytics.
• Represent the QTA function in cross-functional and enterprise forums that influence system architecture, analytics maturity, and digital infrastructure planning.
• Responsible for leading a team and to develop, mentor and foster a culture of innovation, accountability, and continuous learning.

Qualifications

• Bachelor’s degree in a technical or scientific discipline (e.g., Data Analytics, Engineering, Life Sciences) or equivalent work experience.
• 10–15 years of relevant experience in Quality Assurance, preferably with data analytics, digital transformation, and/or automation within the pharmaceutical or biotechnology industry.
• Proven ability to design and implement analytics strategies that align with operational and compliance goals in a GxP environment.
• Experience with data visualization tools (e.g., Power BI) and automation platforms; familiarity with system integrations is a plus.
• Strong understanding of GxP data domains, including Quality Events, metrics, and audit/inspection support.
• Effective communicator with the ability to translate complex data and technology concepts into actionable business insights.
• Demonstrated success leading cross-functional teams and managing change in a regulated environment.
• Excellent organizational and stakeholder engagement skills; ability to manage multiple initiatives in parallel while delivering high-quality outcomes.