Associate Principal IT Product Lead - Quality and Regulatory Systems

Role Summary

The Associate Principal IT Product Lead - Quality and Regulatory Systems will lead a portfolio of digital products essential to Exelixis's strategy to accelerate the development and commercialization of medicines. This role drives the strategy, development, and operational excellence of the digital application ecosystem, aligning with business objectives and focusing on user experience and value delivery. Working within a product-centric model, the role defines product roadmaps, fosters cross-functional collaboration, and leads agile product teams to deliver innovative digital solutions that accelerate drug discovery, development, and commercialization.

Responsibilities

• Product Strategy & Roadmap: Support the development and execution of the vision, strategy, and roadmap for digital products within the Digital Applications job family, specifically Regulatory and Quality Applications.
• Partner with senior product leads and business stakeholders in Regulatory and Quality functions to gather insights, understand user needs, and translate them into clear product requirements and user stories.
• Contribute to market research, competitive analysis, and technology assessments to inform product planning and identify innovation opportunities.
• Assist in prioritizing product initiatives by evaluating business impact, technical feasibility, compliance needs, and resource constraints.
• Collaborate with architecture and engineering teams to ensure digital solutions are designed and built securely and in alignment with enterprise standards.
• Product Development & Delivery: Support the Principal Product Lead in mentoring Business Analysts and other digital application team members, encouraging a culture of ownership, innovation, and continuous improvement.
• Contribute to managing the product lifecycle from ideation through launch and post-launch optimization, applying Agile methodologies (e.g., Scrum, Kanban) to ensure efficient delivery.
• Assist in defining clear user stories, acceptance criteria, and product specifications that align with the product vision and business objectives.
• Collaborate with engineering, architecture, and quality assurance teams to help ensure timely delivery of scalable, secure, and high-quality digital applications.
• Coordinate with external vendors and service providers to support alignment on product roadmaps and delivery operations.
• Promote user-centric design by incorporating user research, usability testing, and feedback into product enhancements.
• Stakeholder Management & Cross-Functional Collaboration: Act as a key liaison between IT and business functions, translating technical concepts into business language and vice versa.
• Build collaborative relationships with stakeholders to support alignment of product vision, priorities, and outcomes.
• Facilitate communication and coordination across product, business, and IT teams to support effective decision-making.
• Represent the product team in cross-functional discussions and contribute to strategic initiatives as needed.
• Operational Excellence, Quality & Compliance: Support efforts to maintain the operational stability, performance, and security of digital applications in collaboration with IT operations and infrastructure teams.
• Assist in managing vendor relationships and third-party software solutions that support the digital application portfolio.
• Help ensure compliance with regulatory requirements (e.g., GxP, HIPAA, GDPR) and internal quality and security standards across product releases.
• Contribute to quality assurance processes to ensure product releases meet defined standards.
• Actively contribute to the implementation and maintenance of robust data management & AI practices to protect sensitive information and ensure its accuracy and reliability.
• Track and report on key performance indicators (KPIs) to assess product success, adoption, and business impact, and support continuous improvement efforts.
• Supervisory Responsibilities: No supervisory responsibilities.

Qualifications

• Minimum of 6 years of experience supporting Enterprise IT enabling business functions.
• Minimum of 8+ years of progressive experience in IT, with at least 6+ years in a leadership role focused on digital applications or product management within the life science or pharmaceutical industry.
• Proven experience leading product development teams in an agile/product-centric operating model.
• Strong understanding of the drug discovery or clinical development, or commercialization lifecycle within a pharmaceutical or biotechnology company.
• Demonstrated success in defining and delivering complex digital products that drive significant business value.
• Experience with one of the mentioned specific technologies or platforms as relevant to the role, e.g., SaaS platforms (Veeva Quality, Veeva RIM, Lorenz DocuBridge, ComplianceWire, Porzio), cloud solutions (AWS, Azure), and/or functional capabilities specific to business function such as QMS, LMS, RIM (Submissions, Registrations and Publishing) systems widely used in pharma.
• Experience with regulatory frameworks and compliance in a GxP environment.

Education

• Bachelor’s degree in related discipline and 11 years of related experience; or
• Master's degree in mathematics or statistics or engineering, and 9 years of related experience.
• PhD degree in a related discipline and 5 years of related experience; or
• Equivalent combination of education and experience.

Skills

• Exceptional leadership and team-building skills, with the ability to inspire and motivate diverse teams.
• Strong strategic thinking and problem-solving abilities, with a data-driven approach to decision-making.
• Excellent communication, presentation, and interpersonal skills, with the ability to influence and collaborate effectively at all levels of the organization.
• Deep understanding of product management methodologies (e.g., Agile, Scrum, Kanban) and product lifecycle management.
• Solid technical acumen with the ability to understand complex IT architectures and development processes.
• Strong background in platforms such as Veeva Quality, Veeva RIM, ComplianceWire and Cloud Computing.

Additional Requirements

• Occasional travel (5–10%) may be required to other company sites, conferences, or vendor locations.
• On-call availability for critical escalations.