Associate Director, Global Quality Systems

Position Overview

The Associate Director, Global Quality Systems will serve as the technical and business owner for Veeva Vault Quality platform, DocuSign, Insights and Analytics Dashboards and other key system integrations, providing strategic leadership in system configuration, data management, and compliance. This role is critical in ensuring the effective implementation and maintenance of quality management systems that support our global operations.

Key Responsibilities

Quality Capability IT System Ownership & Configuration

- Lead the technical ownership of Veeva Vault Quality and other Quality IT capabilities, serving as the primary business owner who liaises with IT counterparts responsible for system configuration, maintenance, and optimization

- Collect, analyze, and translate business requirements into effective system configurations that meet user needs and compliance requirements

- Design and implement data structures that support business insights, reporting capabilities, and system integrations

- Evaluate and manage system upgrades, patches, and new releases, assessing impact on existing configurations and processes

- Develop and maintain system documentation, including business requirements, configuration specifications, and validation documentation

- Maintain solid understanding of Veeva capabilities, best practices and actively engage in the Veeva Community.

- Collaborate with Leads of other Veeva Quality Vaults and GXP systems to align priorities, new capability/features, assess integration opportunities and drive strategic alignment.

- Develop and lead governance forums for Quality and TOQ capability requests.

- Lead a team of business analyst(s) and project manager(s) responsible for effective execution of capability enhancements and system troubleshooting and enhancement requests.

Data Management & Analytics

- Implement data governance and collection practices that establish foundational data, and ensure data is consistent, integral, and accessible

- Define and implement data standards that support effective reporting, analytics, and cross-system integrations

- Lead initiatives to improve data quality and maintain master data management practices

- Create and maintain dashboards and reports that provide meaningful insights to stakeholders

Compliance & Validation

- Support continuous GxP computerized system validation (CSV) compliance through proper documentation, testing, and change control processes

- Lead periodic system reviews and assessments to ensure ongoing compliance with regulatory requirements

- Collaborate with Quality Assurance to maintain system compliance with FDA, EMA, and other relevant regulatory requirements

- Participate in the development of validation strategies, ensuring appropriate risk-based approaches are implemented

Leadership & Collaboration

- Partner with TOQ, Enterprise and IT stakeholders to align system capabilities with business needs

- Lead cross-functional teams in system implementation projects and continuous improvement initiatives

- Provide guidance and technical expertise to system users and administrators

- Manage vendor relationships and coordinate with external consultants as needed

Qualifications

Required Experience & Skills

- Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field

- 10+ years of experience in Quality Systems or related areas within biotechnology or pharmaceutical industries

- 5+ years of experience with Veeva Vault Quality or similar quality management systems

- Demonstrated experience in system configuration, validation, and compliance management

- Strong understanding of GxP regulations and industry quality standards

- Experience with quality management processes and systems (e.g., document control, training management, change control, CAPA)

Preferred Qualifications

- Master's degree in related field

- Experience with system integration and data migration projects

- Knowledge of complementary systems (e.g., ERP, LIMS, MES)

- Experience with Agile methodologies and software development lifecycle processes

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.