Executive Director, Quality Technology & Analytics

Overview 

The Executive Director, Quality Technology & Analytics, is responsible for driving the Quality technology strategy and innovations across Alnylam enterprise capabilities globally. This individual owns the strategy and is the technical leader to oversee the governance of systems owned by Quality (e.g., Veeva Vault, DocuSign, Insights, the Analytics Dashboards, and the Quality Dashboard), and is accountable to ensure not only compliance but to drive innovative solutions within Quality and in service of our business partners.   This individual will provide oversight and strategic leadership in all matters that relate to GXP systems, such as configuration management, integrations, data quality, data management, data retention, etc.   They are accountable for policy implementation that ensures regulatory compliance and appropriate controls, to include data governance and stewardship.  This role is critical to ensure the effective implementation, maintenance, and overall state of data quality to support global, enterprise operations.

Responsibilities:

Driving Quality Technology Strategy:

• Define and drive the Quality Technology & Analytics roadmap, aligned across GxP enterprise functions including research, development, manufacturing, supply chain and commercial.
• Provide oversight and governance to ensure enterprise systems in a state of ongoing compliance and inspection readiness while driving the successful innovation and evolution of key systems such as Veeva, ERP, LIMS, etc.
• Responsible to interpret and translate business needs into scalable, system-agnostic reporting tools in close partnership with Quality Systems and enterprise data teams.
• Evaluate and provide innovative solutions that optimize existing capabilities.

Ensuring Regulatory Excellence and Compliance:

• Responsible to ensure policy, process and governance is in place to ensure compliance is maintained for GxP computerized system validation (CSV).
• Ensure controls are in place and monitored across the enterprise, such as routine audits and periodic system reviews that ensure compliance with FDA, EMA, and other regulatory bodies.
• Responsible to ensure the team develops validation strategies using fit-for-purpose, risk-based methodologies and pragmatic approaches.
• Responsible to ensure technology compliance investigations for GxP systems are performed by technically qualified individuals and in collaboration with IT and relevant business partners.  This role may personally support incidence response to potential cyber-security attacks threatening the enterprise.

Driving Digital Transformation:

• Develop the strategy and drive efforts to modernize legacy systems and transition to cloud-native platforms.
• Enable advanced analytics, machine learning, and AI-driven decision-making in collaboration with Quality, IT, and Business Ops.
• Ensure resource and capabilities are in place to drive the adoption of automation and data analytics across GxP critical functions (manufacturing, research, development, supply chain and commercial).

Enabling Data-Driven Quality:

• Implement robust data governance, collection, and master data management practices.
• Define and implement data standards for cross-system reporting and integration across the enterprise.
• Define and drive best practices for data integrity across GxP stakeholders
• Collaborate with Data Privacy to ensure electronic solutions are compliant with global standards.

Leading Cross-Functional Collaboration:

• Partner GxP Quality Functions, Regulatory Affairs, IT, and various business stakeholders to align tech with business outcomes and regulatory expectations.
• Act as a bridge between IT and Quality, relevant business operations to enable real-time data flow and system integration.

Team & Vendor Leadership:

• Build and lead cross-functional teams across IT, research, development, manufacturing, supply chain and commercial.
• Foster a culture of learning, agility, and collaboration.
• Optimize costs while scaling innovation and owning the quality technology budget.

Competencies:

• Deep knowledge of GxP, HIPAA, FDA, EMA, MHRA compliance, and clinical informatics.
• Experience with quality management processes (Document Management/Control, Learning Management System, Quality Event/CAPA, Audit & Inspection Management).
• Deep understanding of global regulations and guidelines for electronic quality systems, data integrity, electronic records, and electronic signatures including 21 CFR Part 11, Annex 11 and ALCOA++ principles of data integrity. 
• Demonstrated expertise in system configuration, Software Life Cycle (SLC) Software Development Life Cycle (SDLC) validation and compliance.
• Strategic mindset with execution-focus and passion for innovation.
• Effective oral and written communication skills.
• Excellent organizational and analytical skills and demonstrated ability to handle multiple projects at the same time and shift priorities when needed to meet a constantly changing environment. 
• Ability to demonstrate clear alignment with Alnylam Core Values at a leadership level. 

Qualification:

• 15-20+ years of experience in technology leadership, preferably in life sciences, biotech, or pharmaceuticals.
• Bachelor of Arts, Bachelor of Science, or equivalent work experience
• 5+ years of experience with Veeva Vault Quality or similar quality management systems.
• 5+ years of experience leading and developing teams
• Strong understanding of GxP, HIPAA, FDA, EMA, MHRA compliance and clinical informatics.
• Demonstrated experience in system configuration, validation, and compliance management
• Demonstrated experience leading cross-functional initiatives
• Experience with quality management processes and systems (e.g., document control, training management, change control, CAPA)
• Strategic mindset paired with a can-do attitude.
• Passion for technology and innovation

About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.