How You Will Achieve More:

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.

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

About You:

• 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
• Master’s degree or equivalent professional experience preferred
• Certifications in change management (e.g., Prosci) or quality systems a plus

Required:

• 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

Preferred:

• 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
• Prolonged periods of sitting at a desk and working on a computer. Must be able to travel occasionally for audits, cross-functional meetings, and team events.

EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Applications are accepted on a rolling basis, and will continue to be accepted until the position is filled at which point the position will be taken down.

The base salary for this position is expected to range between $163,107.00 - $199,353.00 USD per year.

The salary offered is determined based on a range of factors including, but not limited to, relevant education and training, overall related experience, specialized, rare or in-demand skill sets, internal comparators and other business needs. Upon joining Intellia, your salary will be reviewed periodically and additional factors such as time in role and performance will be considered. Intellia may change the published salary range based on company and market factors.

Additional compensation includes a performance-based annual cash bonus, a new hire equity grant, and eligibility to be considered for annual equity awards the value of which are determined annually at the Company’s discretion.

For more information about Intellia’s benefits, please click here.