Manager, Business Systems IT & Compliance
South San Francisco, CA

Job Description

Overview

The Manager, Business Systems and IT Compliance role is to plan, coordinate, and supervise all activities related to the acquisition, design, development, implementation, deployment and support of Atara Bio's Enterprise Resource Planning (ERP) system and software applications supporting Atara Bio's financial, legal, compliance and HR teams and other efforts as necessary. In addition, the responsibilities include managing programs for regulatory, financial, and legislative compliance. This individual will apply proven communication skills, problem-solving skills, and knowledge of best practices to guide his/her team on issues related to the design, development, and deployment of mission-critical information and software systems.

This is a technical hands-on management position.

Responsibilities

We launched Atara Biotherapeutics in August 2012 to help patients with serious diseases and few therapeutic options. We're named after Atara Ciechanover who suffered from cancer before passing away. We are considered a leading off-the-shelf T-cell immunotherapy company (Nasdaq ATRA) developing novel treatments for patients with cancer, autoimmune and viral diseases.

Position Summary:

The Manager, Business Systems and IT Compliance role is to plan, coordinate, and supervise all activities related to the acquisition, design, development, implementation, deployment and support of Atara Bio's Enterprise Resource Planning (ERP) system and software applications supporting Atara Bio's financial, legal, compliance and HR teams and other efforts as necessary. In addition, the responsibilities include managing programs for regulatory, financial, and legislative compliance. This individual will apply proven communication skills, problem-solving skills, and knowledge of best practices to guide his/her team on issues related to the design, development, and deployment of mission-critical information and software systems.

This is a technical hands-on management position.

Reports to: Sr. Manager Business Systems & IT Compliance

Location: South San Francisco, CA.

Responsibilities:

Strategy and Planning

* Strategically creates growth through improving enterprise systems and processes.
* Develops talent in a strong team by identifying potential, developing and motivating team members.
* Drives customer value through technology roadmaps and delivering against them.
* Manages diverse business partner relationships and accountability.
* Leads/supports the expansion of existing department systems to enterprise use.
* Evaluates proposals for applications or expansion of use of an existing system in order to identify potential problem areas, and make the appropriate recommendations.
* Ensures that proposed applications and systems meet business requirements and goals, fulfill end-user requirements, and identify and resolve systems issues.
* Reviews and renew contracts.
* Reviews and analyzes existing application effectiveness and efficiency, and then develops strategies for improving or leveraging these systems.

Acquisition and Deployment

* Coordinates and facilitates consultation with stakeholders to define business and systems requirements for new technology implementations and information services in finance, legal and HR.
* Guides the approval, prioritization, and control of projects and the project portfolio as they relate to the selection, acquisition, development, and installation of major information systems.
* Manages the development and deployment of new applications, systems software, and/or enhancements or expansion of use of existing applications throughout the enterprise that significantly improve business operations.
* Applies expertise in regulatory GxP computer software validation practices and associated change management methodologies to improve Atara Bio's systems.
* Prepares validation testing as necessary for system upgrades and patches.
* Applies experience in meeting corporate IT SOX requirements.
* Coordinates and manages internal and external auditor requirements.
* Ensures that any new software integration into company systems meets functional requirements, system compliance, and interface specifications.
* Collaborates with analysts, designers, and business process owners, and system owners in the testing of new software capabilities, programs and applications.
* Works with Information System staff to ensure system(s) will fit into existing infrastructure and meets Atara Bio standards for hardware/software systems.

Operations and Support

* Manages and provides direction for the enterprise application team in support of business operations.
* Identifies and resolves program errors.
* Serves as validation lead for all IS systems.
* Provides technical leadership to project managers, business analysts and programmers working on application project teams.
* Designs, develops, and installs enhancements and upgrades to systems and application software.
* Works with other Information System staff to assist with quality assurance, program logic, and data processing.
* Cultivates, disseminates, and enforces functional policies, procedures, and quality assurance best practices.
* Where necessary, prepares, establishes, and monitor budgets.
* Works with business owners to formulate and conduct training sessions and teaching materials for propagating enterprise applications knowledge throughout the organization as appropriate.
* Recommends, schedules, and performs software improvements, patches, upgrades, and/or purchases.
* Supervisory responsibilities include interviewing, hiring, and training employees: planning, assigning, and directing work; performance management and reviews; staff development; addressing complaint and resolving problems.
* Performs IS application administration tasks

Travel: Up to 20%

Qualifications

Position Requirements:

Formal Education and Certification

* Degree in Computer Science or related field and 10 years work experience in deploying and supporting systems.
* PMI Project Management Professional certification.

Knowledge and Experience

* 10 years' direct experience in software deployment, development and/or programming design and systems management in an FDA Regulated Environment.
* Proven experience in overseeing the direction, development, and implementation of software solutions and deployment of 3rdparty hosted solutions.
* Proven experience with Microsoft Dynamics AX (AX - preferred), or other ERP platform in a Life Sciences company.
* Direct, hands-on experience with Sharepoint, and Power BI are preferred.
* Expertise in system and process automation practices and methodologies.
* Understanding and experience of IT SOX control testing, processes, and reviews.
* Extensive experience with core software applications, including Concur, and HRIS systems like ADP.
* Lead the implementation of HCP Aggregate Spend reporting and Human Capital Management systems.
* Demonstrated capabilities with change management, corrective action/preventive action plans, and IT Management systems.
* Good project management skills and/or substantial exposure to project-based work structures, project lifecycle models, etc.
* Knowledge of database design and file management technique.
* Strong understanding of basic system engineering, object-oriented design, information risk and security guidelines, and architecture standards.
* Knowledge of applicable regulatory requirements, data privacy practices and laws including FDA 21 CFR Part 11 and HIPAA.
* Proficiency in computer systems validation, including authoring IQ/PQ/OQ documents.

Communication and Interpersonal Skills:

* Strong customer-service orientation.
* Excellent written and oral communication skills.
* Excellent listening and interpersonal skills.
* Ability to communicate ideas in both technical and user-friendly language.
* Ability to conduct research into application issues and products.
* Highly self-motivated and directed.
* Keen attention to detail.
* Able to prioritize and execute tasks in a high-pressure environment.
* Experience working in a team-oriented, collaborative environment.
* An innovative, data-driven person with a "can do" attitude and willingness to do the work.
* High bar personal ethics with a "patients first" value system.
* Role model for Atara's values.

More About Atara Bio:

Now in our sixth year, we're proud of our team of 300+ Atarians co-located by design in South San Francisco (corporate headquarters) and Southern California (R&D and manufacturing headquarters in the northwest Los Angeles area) with a newly-established European headquarters in Zug, Switzerland. Atara also has a R&D site in the Denver, Colorado area and an office in New York City. Our Southern California hub is anchored by a new 90,000 sq. ft., state-of-the-art Atara T-Cell Operations and Manufacturing (ATOM) facility in Thousand Oaks, California.

One mission - "Transform the lives of patients with serious medical conditions through pioneering science, teamwork and expertise" - and a singular vision - "Cell therapy treatment for every patient, any time - provide inspiration and direction for all of us."

The Company's off-the-shelf, allogeneic T-cells are bioengineered from donors with healthy immune function and allow for rapid delivery from inventory to patients without a requirement for pretreatment. Atara's T-cell immunotherapies are designed to precisely recognize and eliminate cancerous or diseased cells without affecting normal, healthy cells.

Atara's most advanced T-cell immunotherapy in development, tabelecleucel, or tab-cel™ (formerly known as ATA129), is being developed for the treatment of patients with Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who have failed rituximab, as well as other EBV-associated hematologic and solid tumors, including nasopharyngeal carcinoma (NPC). Tab-cel™ is in Phase 3 clinical development for the treatment of EBV+ PTLD following an allogeneic hematopoietic cell transplant (MATCH study) or solid organ transplant (ALLELE study).

Atara is also developing off-the-shelf, allogeneic ATA188 and autologous ATA190 T-cell immunotherapies using a complementary targeted antigen recognition technology for specific EBV antigens believed to be important for the potential treatment of multiple sclerosis (MS). A Phase 1 clinical study of autologous ATA190 in patients with progressive MS is ongoing. Atara is also advancing a Phase 1 clinical study of ATA188 in patients with progressive or relapsing-remitting MS across clinical sites in the United States and Australia. Atara's clinical pipeline also includes ATA520 targeting Wilms Tumor 1 (WT1) and ATA230 directed against cytomegalovirus (CMV).

Working at Atara Bio:

People at Atara Bio are high integrity, roll-up-your-sleeves, get-it-done types who are keenly committed to putting patients first, advancing medical care and doing so with demonstrated urgency. At their core Atarians are people who work well with others and are "team-centric", have purposeful curiosity and can't wait to save patient lives. And similar to other biotech companies who have so many accomplished people, we expect humility (we are a "low hubris" sort of place), flexibility, respect, teamwork, good judgment and getting the most out of any dollar we spend. We also expect to enjoy the journey (and each other) as we move forward with a shared responsibility to teach and to learn from what we do and from our teammates.

Atara Bio is an equal opportunity employer and makes employment decisions on the basis of merit and other lawful factors. In accordance with applicable law, the Company prohibits discrimination based on race, color, religion, creed, sex, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity, expression or dysphoria, marital status, age, national origin or ancestry, physical or mental disability, medical condition, genetic information, veteran status, caregiver status, sexual orientation, transgender status or any other classification protected by federal, state or local laws or because of the individual's association with a member of a protected group or connection to an organization or group related to a protected group.

We comply with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Atara Bio in the United States.

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