Manager II, Enterprise Applications (R&D & GxP Systems)
Irvine, California, United States · Hybrid
$134k–$188k/yr
Senior+$711M raised
Hi Tarsan! Thanks for your interest in this position. Please review the details and if role and if it's something that could match your career goals, connect with your current manager and HRBP to discuss if your experien…
Skills: GxP Compliance, Veeva Vault, System Development Lifecycle (SDLC), Validation Testing, Change Management
Hi Tarsan! Thanks for your interest in this position. Please review the details and if role and if it's something that could match your career goals, connect with your current manager and HRBP to discuss if your experien…
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Hi Tarsan! Thanks for your interest in this position. Please review the details and if role and if it's something that could match your career goals, connect with your current manager and HRBP to discuss if your experien…
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Hi Tarsan! Thanks for your interest in this position. Please review the details and if role and if it's something that could match your career goals, connect with your current manager and HRBP to discuss if your experien…
Hi Tarsan! Thanks for your interest in this position. Please review the details and if role and if it's something that could match your career goals, connect with your current manager and HRBP to discuss if your experien…
Hi Tarsan! Thanks for your interest in this position. Please review the details and if role and if it's something that could match your career goals, connect with your current manager and HRBP to discuss if your experien…
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Hi Tarsan! Thanks for your interest in this position. Please review the details and if role and if it's something that could match your career goals, connect with your current manager and HRBP to discuss if your experien…
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Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
$134k–$188k/yr
Full-time
bachelor degree
Health Insurance, Dental Insurance, Vision Insurance, Bonus, Stock Equity, Paid Time Off
Posted 67d ago
~40 hrs/week
Responsibilities
Acts as the IT system owner for GxP applications, ensuring compliant operations and validation across Clinical, Regulatory, and Quality functions. Responsible for system configurations, upgrades, and partnering with Quality and vendors to maintain inspection readiness.
Requirements
Requires a Bachelor's degree and 8+ years of IT experience in life sciences, with at least 6 years specifically supporting GxP systems. Strong expertise in Veeva Vault and regulatory standards like 21 CFR Part 11 and EU Annex 11 is highly preferred.
Full job description
Hi Tarsan!
Thanks for your interest in this position. Please review the details and if role and if it's something that could match your career goals, connect with your current manager and HRBP to discuss if your experience and skills line up. If everything is a go, please apply and the Talent Acquisition team will contact you for an interview so we can also get to know you better.
- Your Human Resources Team
About the Role
The Manager II, Enterprise Applications (R&D & GxP Systems) is a hands-on role responsible for GxP IT system owner activities across GxP applications, ensuring compliant operations in partnership with the business, Quality, and vendor partners. The role includes configuring and testing the systems, maintaining validation activities, managing system upgrades and releases, and contributing to SOPs, training, and process improvements to keep systems aligned with business needs and regulatory requirements.
Let’s talk about some of the key responsibilities of the role:
Act as a subject matter expert and IT system owner for assigned GxP applications, including Veeva Vault platforms and other validated systems supporting Clinical, Regulatory, Quality and other regulated functions
Support the execution of the IT roadmap and system implementations for Clinical, Regulatory and other functional teams performing requirements gathering, risk assessment, impact assessment, solution design, system configurations, testing, and validation activities.
Perform requirement gathering, risk assessment, impact assessment of new implementations and existing systems changes
Collaborate with business stakeholders, IT, Quality and external vendors to implement new systems and provide day-to-day operations support for assigned GxP systems
Partner closely with Quality and external vendor partners on GxP systems operations, change management, CAPAs, periodic reviews, GxP inspection readiness, and support audits/inspections, including presenting system documentation when required
Coordinate and support validation testing including user acceptance testing (UAT) of system changes and ensure quality production deployments
Review and own IT activities for change control requests and provide all required documentation for GxP systems
Assist with data management, migration, integration, and analytics across GxP systems, ensuring business needs are met
Manage periodic reviews, upgrades and releases including release assessments.
Collaborate with cross-functional teams and support the business stakeholders to identify and implement process improvements, enhancing system efficiency and effectiveness
Contribute to the development, review, and maintenance of SOPs, work instructions, and policies related to GxP systems
Ensure the assigned GxP systems remain inspection-ready, with complete, accurate, and defensible validation and compliance documentation
Factors for Success:
Bachelor’s degree in Computer Science, Information Systems, Engineering, Quality, Regulatory, or Business, with 8+ years of relevant IT experience in the life sciences or pharmaceutical industry
6+ years of experience implementing and supporting GxP systems, including clinical, regulatory, quality and other GxP applications
Solid understanding of business processes, System Development Lifecycle (SDLC) and validation in a GxP-regulated setting, including strong knowledge of 21 CFR Part 11, EU Annex 11, and GxP compliance practices; familiarity with ICH GCP regulations is a strong plus
Hands-on experience with Veeva Vault applications (e.g. RIM, CTMS, eTMF ) strongly preferred; certifications in Veeva Vault modules are a plus
Experience working with a QMS, GxP LMS systems or other GxP systems is a plus
Working knowledge and familiarity with statistical tools (e.g., Minitab, JMP); exposure to JReview for analytics is a plus
Familiarity with both waterfall and Agile project management methodologies
Strong communication and problem-solving skills, with the ability to work independently, proactively identify challenges, and drive accountability
Experience managing vendors, system integrators, and SaaS providers in both project and support contexts
Commitment to staying current on new technologies and industry trends to ensure systems deliver optimal value
Tarsus Competencies:
Decision Making - Demonstrates strong decision-making by applying structured analysis to complex challenges, balancing competing priorities and long-term impacts while engaging stakeholders and driving solutions aligned with organizational goals.
Collaboration and Team Building - Promotes collaboration by aligning diverse teams around shared goals, fostering healthy debate to advance outcomes, and building strong networks that strengthen organizational effectiveness and cross-team learning.
Outcome Driven - Demonstrates strong outcomes focus by aligning teams around shared priorities, proactively addressing risks and dependencies, and driving cross-functional accountability to sustain progress and deliver results.
A Few Other Details Worth Mentioning:
The position will be based in our beautiful Irvine office, complete with onsite gym, pool, snacks, drinks, and occasional catered meals. We provide a hybrid work environment.
Remote will be considered, but preference will be given to onsite/hybrid candidates
This position reports directly to our Director, Enterprise Applications (R&D Systems)
Some travel may be required – up to 10%
At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $134,200 - $188,000 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://eb.alliant.com/26tarsusbenefitssnapshot.
#LI-Hybrid
Related keywords
GxPVeeva VaultRIMCTMSeTMFSDLC21 CFR Part 11EU Annex 11ICH GCPQMSLMSMinitabJMPJReviewAgileWaterfall
Tarsus (NASDAQ:TARS) is a biopharmaceutical company that applies proven science and new technology to revolutionize treatment for patients, starting with eye care.
Offices: 15440 Laguna Canyon Rd, Irvine, California 92618, US