Senior Director, Audits, Inspections, & QMS

Overview

The Senior Director of Quality Analytics and Automation is a key leadership role within the Quality organization, responsible for advancing the use of data, metrics, automation and artificial intelligence (AI) to enable insight-driven decision-making and improve operational efficiency across the GxP enterprise landscape. Reporting to the Executive Director, Quality Technology and Analytics (QTA), this role leads efforts to build scalable reporting capabilities, enhance Quality’s digital roadmap and maturity, and identify technology-enabled opportunities to simplify and modernize core processes.

This individual is the business owner and responsible for the day-to-day execution and decision-making for systems owned by Quality, such as the Veeva Vault Quality platform, DocuSign, Insights and Analytics Dashboards, and other key system integrations. This role is critical in ensuring the effective implementation of procedures and maintenance of quality management systems that support our global operations. This role is responsible to identify and lead data integrity initiatives to improve data quality and data standards across the enterprise.

The role will partner closely with stakeholders and senior leaders across Quality, Technical Operations, Development, IT, and other key stakeholders across the enterprise to deliver sustainable, data-enabled solutions. The role requires the ability to influence and interact with senior leaders across the enterprise and serves as a bridge between technical innovation and operational excellence

This position can be remote, hybrid, or onsite in the Cambridge, MA office. Preference for a US-based colleague with frequent access to key stakeholders in Cambridge.

Key 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.

About Alnylam: We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.