FDA 21 CFR

Part 11 Managing IT teams Client relationship development Reporting and dashboarding tools Enterprise software systems development Managing IT procurement budgets Data integrity and documentation Bachelor's degree Technology management Pharmaceutical company experience Enterprise Integration Vendor relationship management Operating budgeting Vendor communication Leading team collaboration initiatives Data validation GMP for research safety and compliance Cross-functional team management Project stakeholder communication Data analytics technologies Cross-functional communication Laboratory compliance and regulatory documentation Full Job Description Job Summary This Technical leader will be responsible for the end-to-end design, development, lifecycle management, and compliance of cross-functional, multi-platform application systems. This role acts as the accountable System Owner, ensuring data integrity, system security, and high operational availability across the enterprise. The individual will manage a team of validation engineers and system administrators while partnering strategically with key business departments including Quality Control, Analytical Development, Scientific Innovation (R D), and Process Formulations Development—to drive technology initiatives that meet strict regulatory standards.

Reports to:

Director, IT R D Location:

Newark, CA (onsite)

Salary:

$150,000-$200,000 annually + annual performance bonus Essential Duties/Responsibilities Provide strategic direction for the IT R D lab systems and CSV process improvement programs. Own the lab modernization roadmap and reduce technical debt across R D lab environments. Provide technical guidance on development, configuration, and implementation efforts for lab systems, while building the expertise of IT colleagues. Define short- and long-term goals for the IT R D lab space that align with business strategy. Consult business clients and IT colleagues to design solutions that balance performance, client service, and cost management. Manage system rollouts, scientific applications (laboratory informatics) and system upgrades impacting R D labs. Serve as a subject matter expert for complex cross-functional projects, ensuring customer needs are fully addressed. Build and manage a team of validation engineers and system administrators supporting the full SDLC, steady state operations, and audit readiness. Additional responsibilities may require system administration duties for systems. Develop systems, processes, and procedures that improve efficiency, reduce expense, and strengthen service delivery. Partner with business owners to minimize downtime and maximize compliance for laboratory systems. Serves as a technical resource on projects that involve multiple technologies, highlights operational or implementation risks, complex business functionality, and broad implications for the business and/or the IT architecture. Establish monitoring for operating efficiency and arrange proactive maintenance where needed. Ensure production support and issue resolution meet business needs, with process improvements as required. Maintain awareness of projects or changes to other systems to prevent service degradation. Develop operational performance metrics and report performance regularly to cross-functional stakeholders. Conduct periodic audits and annual physical inventory verification of computerized systems throughout R D to ensure that systems are current and continue to function appropriately for their current intended use. Execute and document all User Access verifications for data integrity and compliance requirements. Ensure software license management, backup procedures, and CSV documentation are maintained for applicable systems. Education BA/BS in computer science or related field. Experience 10+ years of relevant experience in an IT Business Application and Relationship Management role in a Biotechnology or Pharmaceutical environment.

Knowledge, Skills and Abilities Minimum Required:

Experience with one or more system areas of focus within the business partners that this position supports, for example, standalone laboratory equipment, EMPOWER, LIMS, LabX, SoftmaxPro, Particle Measuring Systems, QMS, EDMS, and LMS. Extensive experience in IT R D lab systems, laboratory informatics, and CSV in regulated environments. Demonstrated leadership in lab modernization, system lifecycle management, and cross-functional stakeholder engagement. Strong understanding of GxP, data integrity, SDLC, and validated system support. System integration, dashboards, analytics, and digital transformation in scientific environments. Budgeting, service management, and vendor coordination in enterprise IT settings. Strong communication, prioritization, and problem-solving skills. Proficient in current Good Manufacturing Practices (cGMPs), Part 11 and Annex 11 requirements. Strong leadership and project management skills. Detailed-oriented, systematic, and rapid learner. Excellent planning and organizational skills. Exceptional written and verbal communication skills.

Preferred:

PMP certification Experience with SharePoint functionality and collaboration. Experience with Veeva applications

Company Summary:

Revance is a global company developing, producing, and distributing industry-leading, differentiated products across aesthetics, skincare, and therapeutics. Revance drives innovation beyond convention to offer treatment options for individuals across generations. The Company's vision is to redefine excellence in aesthetics, skincare, and therapeutics through science-powered innovation, with an unwavering commitment to its providers, patients, and consumers. Revance's award-winning products are the result of robust research and development, a cornerstone for the Company, driven by renowned scientists. For more information about Revance, please visit us at www.revance.com.

What Revance invests in you:

Competitive Compensation including base salary and annual performance bonus. Flexible PTO, holidays, and parental leave. Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more! This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a \"qualified individual with a disability\" in all aspects of the employment relationship. A \"qualified individual with a disability\" is \"an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.\" Revance is an Equal Opportunity employer. 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