Back to jobs
tags.new

Manager II, Enterprise Applications (R&D Systems)

Irvine, California, United States

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 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, and Quality functions
  • Support the execution of the IT roadmap and system implementations for Clinical and Regulatory 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 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

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, and quality applications
  • Hands-on experience with Veeva Vault applications (CDMS, RIM, RTSM, CTMS, or eTMF) strongly preferred; certifications in Veeva Vault modules are a plus
  • 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 plus
  • Working knowledge of SQL 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

A Few Other Details Worth Mentioning:

  • The position will be based in our beautiful Irvine office, complete with a courtyard, 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 Associate 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 $131,200 - $183,800 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://alliantbenefits.cld.bz/25tarsusbenesnap.

#LI-Hybrid

Create a Job Alert

Interested in building your career at Welcome to the Tarsanet Internal Career Center!? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Select...
Select...
Select...
Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Welcome to the Tarsanet Internal Career Center!’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.