Senior Manager, Digital Compliance and QMS

Intellia•Cambridge, MA

27d

About The Position

The Sr. Manager, Digital Compliance and QMS is a critical individual contributor role responsible for driving the strategy, implementation, and continuous improvement of Quality Management Systems (QMS) and digital compliance platforms across the organization. This role serves as the subject matter expert (SME) for Veeva Quality Vault and related GxP systems, ensuring regulatory compliance, optimized user adoption, and operational excellence. The ideal candidate thrives in a fast-paced, intellectually curious environment, brings deep expertise in People Change Management, and possesses the ability to translate complex compliance requirements into actionable strategies. This role requires strong communication and presentation skills to engage leadership, cross-functional teams, and internal stakeholders through training programs, learning series, and quality forums.

Requirements

Excellent time management skills with a proven ability to meet deadlines and manage multiple concurrent initiatives
Strong analytical and problem-solving skills
Strong communication and presentation skills with the ability to engage leadership, cross-functional teams, and large internal audiences
Ability to prioritize tasks and delegate them when appropriate
Ability to function well in a high-paced and at times stressful environment
Proficient with Veeva Quality Vault and related GxP compliance platforms
Experience with enterprise platform implementations and system lifecycle management (e.g., ERP, QMS, LMS)
Strong interpersonal skills with the ability to influence without authority and drive cross-functional alignment
Bachelor’s degree in Life Sciences, Natural Sciences, Engineering, Information Systems, or related field
8+ years of progressive professional experience in operations management, enterprise platform administration, systems implementation, or related roles
3+ years of direct experience in QMS administration, digital compliance, or quality systems within a regulated life sciences environment (biotech, pharmaceuticals, or medical devices)
Hands-on experience with Veeva Quality Vault
Demonstrated expertise in Document Control and Change Management processes
Proven experience leading enterprise-wide system implementations or deployments, including end-to-end project lifecycle management
Working knowledge of Computer System Validation principles, including 21 CFR Part 11 and EU Annex 11
Proven track record in People Change Management and training program development, including large-scale user adoption strategies
Strong presentation and communication skills with comfort engaging leadership, cross-functional teams, and diverse internal audiences

Nice To Haves

Master’s degree or equivalent professional experience preferred
Certifications in change management (e.g., Prosci) or quality systems a plus
Experience with digital adoption platforms
Understanding of Data Governance Frameworks as they apply to Artificial Intelligence
Experience supporting regulatory inspections (FDA, EMA, or other)
Experience with ERP systems or enterprise platform integrations
Experience designing and facilitating internal training programs, learning series, or communities of practice

Responsibilities

Quality Management Systems & Digital Compliance Serve as an SME for Veeva Quality Vault, including configuration, optimization, and end-user support across all QMS modules (Document Control, Change Management, CAPA, Deviations, Audits, Training)
Support the enterprise Document Control function, ensuring GxP documentation is compliant, accessible, and efficiently managed
Drive continuous improvement initiatives for QMS processes, leveraging data analytics and system capabilities to enhance compliance posture
Partner with IT and Quality leadership to define system roadmaps and prioritize enhancements based on business needs and regulatory requirements
Ensure inspection readiness by maintaining audit trails, system documentation, and compliance metrics
Computer System Validation (CSV) Support and execute Computer System Validation activities for GxP systems, including validation planning, risk assessments, and protocol development
Ensure systems comply with 21 CFR Part 11, EU Annex 11, and applicable GAMP 5 guidelines
Manage validation lifecycle activities including IQ, OQ, PQ, UAT, and periodic reviews
Maintain validation documentation and support regulatory inspections related to computerized systems
Training & People Change Management Design and execute comprehensive training programs for QMS and digital compliance platforms, ensuring high user adoption and proficiency
Lead change management initiatives for system implementations, upgrades, and process changes across the organization
Develop communication strategies to drive awareness, engagement, and buy-in from stakeholders at all levels
Leverage digital adoption platforms to enhance user experience and reduce support burden
Communication & Stakeholder Engagement Develop and deliver engaging presentations to internal stakeholders, cross-functional leadership, and quality governance forums on compliance strategy, system capabilities, and best practices
Lead recurring internal learning programs including Communities of Practice, Learning Series, and Office Hours to drive continuous education and user proficiency
Serve as a visible, accessible resource across the organization, building trust and credibility through clear communication and stakeholder engagement
Build and maintain relationships with vendors and technology partners to stay current on platform capabilities and industry trends
Cross-Functional Collaboration Partner with Development, Clinical Operations, and IT to ensure QMS capabilities align with business needs
Drive alignment between Quality, IT, and business stakeholders on digital compliance priorities