Softbank Investment advisers
Director, IT GxP Systems
Softbank Investment advisers, Hayward, California, us, 94557
About ArsenalBioArsenalBio is a privately held, programmable cell therapy company focused on the realization of solid tumor cell therapy to defeat cancer.
Job Description
Arsenal Biosciences Inc. is a clinical stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors. We are seeking a talented and experienced Director, IT GxP Systems to work onsite based in our Hayward office.
The IT Director for Tech Ops GxP Systems will play a key leadership and contributor role in supporting and driving all IT GxP programs and initiatives within ArsenalBio. This role will design, develop and manage all cross-functional deliverables and stakeholder commitments required to support and maintain the IT Manufacturing systems including ERP, MES, Inventory, CT orchestration systems and automated CGT equipment vendors. This will be a critical role responsible for delivering ArsenalBio’s IT Manufacturing technology roadmap, implementing and evolving system SDLC, providing technical support, establishing a support model and ensuring the delivery of IT manufacturing capabilities.
WHAT YOU’LL DO
Develop and manage the portfolio of Tech Ops IT projects. Align IT Manufacturing technology roadmap with Manufacturing strategy, information security, GxP compliance requirements and enterprise IT architecture.
Comprehensive business understanding of Quality and Regulatory functions within a life sciences organization.
Deep understanding of the necessary activities required to drive IT compliance to support regulatory filing, regulatory inspection, and commercial launch.
Knowledge of 21 CFR Part 11, Annex 11, data integrity, and CSV process and clear vision for establishing a validation service to GxP stakeholders.
Significant experience implementing SaaS systems and other software solutions to support regulated life science business processes.
Serve as a technical subject matter expert to the organization and customers, and mapping customer requirements to software capabilities of IT systems ensuring optimal technical implementation.
Own the System Lifecycle Management of Manufacturing application systems and interfaces.
Lead the development of Service Agreements, Maintenance Agreements, Operating level agreements to enable end to end IT support delivery.
Lead the requirements collection, definition phase and the design of software solutions and provide necessary business context into technical design discussions while working within defined enterprise architecture.
Document/diagram functional process flows to ensure optimization and synchronization of systems, including identifying/advising on best applications for specific business processes, including cloud-based systems.
Facilitates use case/story boarding for new systems/software or enhancements related to ERP and other manufacturing systems and processes.
Develop and establish departmental SOPs, qualification/validation protocols and reports with ongoing awareness to changes in business or regulatory.
Provide technical leadership to project managers, business analysts and programmers working on application/data analytics project teams.
Work with business owners to formulate and conduct training sessions and teaching materials for propagating enterprise applications knowledge throughout the organization as appropriate.
Recommend, schedule, and perform software improvements, patches, upgrades, and/or purchases.
WHO YOU ARE
Bachelor’s degree in IT, CS, Business Process Management or related discipline or equivalent number of years of work experience.
Minimum 10 years direct IT experience in roles of increasing responsibility in project/program management, business analysis, or other delivery leadership roles within a life sciences IT organization and 5 years of IT leadership experience.
Experience with GMP environment, computer system validation, change management, and discrepancy reporting.
Minimum of 5 years of working experience with SAP including hands on experience implementing SAP.
Technical mastery and knowledge of the relevant industry.
Strong understanding of concepts of and hands on experience in MES systems architecture, installation and version management.
Experience on GxP applications (and good Documentation Practices) and working in SOX audited environments is a plus.
Ability to support mission-critical business solutions.
Experience designing and implementing Incident, Problem Change, Version, Release, Configuration, Continuity management for mission critical manufacturing systems at a scale.
Track record working in a fast paced, highly iterative environment.
Should be able to communicate complex solutions and value in business terms.
Experience in Life Sciences is preferred.
BENEFITS AND PAY
ArsenalBio has a generous and comprehensive benefits package that includes but is not limited to medical, dental, and vision as well as mental health resources, virtual and telehealth options, coaching, infertility treatment, parental leave and health savings accounts. We also offer flexible work schedules and flexible time off, which includes two extra “Arsenal Days of Rest” every quarter for employees to recharge.
We are committed to hiring the best talent from diverse backgrounds. A diverse workforce engenders richness of thought, creativity and discovery. We invite individuals who embrace intellectual achievement to bring their unique personal and professional journeys and together we will build transformative cell therapies for cancer patients.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
The estimated base salary offer for the preferred primary location of San Francisco Bay area ranges from $194,300 – $238,000. Salary ranges for other locations may vary from this range. Base pay offered may vary depending on job related knowledge, experience, education, and location.
To all recruitment agencies: ArsenalBio does not accept agency resumes. Please do not forward resumes to our jobs alias, or ArsenalBio employees. ArsenalBio is not responsible for any fees related to unsolicited resumes.
#J-18808-Ljbffr
Job Description
Arsenal Biosciences Inc. is a clinical stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors. We are seeking a talented and experienced Director, IT GxP Systems to work onsite based in our Hayward office.
The IT Director for Tech Ops GxP Systems will play a key leadership and contributor role in supporting and driving all IT GxP programs and initiatives within ArsenalBio. This role will design, develop and manage all cross-functional deliverables and stakeholder commitments required to support and maintain the IT Manufacturing systems including ERP, MES, Inventory, CT orchestration systems and automated CGT equipment vendors. This will be a critical role responsible for delivering ArsenalBio’s IT Manufacturing technology roadmap, implementing and evolving system SDLC, providing technical support, establishing a support model and ensuring the delivery of IT manufacturing capabilities.
WHAT YOU’LL DO
Develop and manage the portfolio of Tech Ops IT projects. Align IT Manufacturing technology roadmap with Manufacturing strategy, information security, GxP compliance requirements and enterprise IT architecture.
Comprehensive business understanding of Quality and Regulatory functions within a life sciences organization.
Deep understanding of the necessary activities required to drive IT compliance to support regulatory filing, regulatory inspection, and commercial launch.
Knowledge of 21 CFR Part 11, Annex 11, data integrity, and CSV process and clear vision for establishing a validation service to GxP stakeholders.
Significant experience implementing SaaS systems and other software solutions to support regulated life science business processes.
Serve as a technical subject matter expert to the organization and customers, and mapping customer requirements to software capabilities of IT systems ensuring optimal technical implementation.
Own the System Lifecycle Management of Manufacturing application systems and interfaces.
Lead the development of Service Agreements, Maintenance Agreements, Operating level agreements to enable end to end IT support delivery.
Lead the requirements collection, definition phase and the design of software solutions and provide necessary business context into technical design discussions while working within defined enterprise architecture.
Document/diagram functional process flows to ensure optimization and synchronization of systems, including identifying/advising on best applications for specific business processes, including cloud-based systems.
Facilitates use case/story boarding for new systems/software or enhancements related to ERP and other manufacturing systems and processes.
Develop and establish departmental SOPs, qualification/validation protocols and reports with ongoing awareness to changes in business or regulatory.
Provide technical leadership to project managers, business analysts and programmers working on application/data analytics project teams.
Work with business owners to formulate and conduct training sessions and teaching materials for propagating enterprise applications knowledge throughout the organization as appropriate.
Recommend, schedule, and perform software improvements, patches, upgrades, and/or purchases.
WHO YOU ARE
Bachelor’s degree in IT, CS, Business Process Management or related discipline or equivalent number of years of work experience.
Minimum 10 years direct IT experience in roles of increasing responsibility in project/program management, business analysis, or other delivery leadership roles within a life sciences IT organization and 5 years of IT leadership experience.
Experience with GMP environment, computer system validation, change management, and discrepancy reporting.
Minimum of 5 years of working experience with SAP including hands on experience implementing SAP.
Technical mastery and knowledge of the relevant industry.
Strong understanding of concepts of and hands on experience in MES systems architecture, installation and version management.
Experience on GxP applications (and good Documentation Practices) and working in SOX audited environments is a plus.
Ability to support mission-critical business solutions.
Experience designing and implementing Incident, Problem Change, Version, Release, Configuration, Continuity management for mission critical manufacturing systems at a scale.
Track record working in a fast paced, highly iterative environment.
Should be able to communicate complex solutions and value in business terms.
Experience in Life Sciences is preferred.
BENEFITS AND PAY
ArsenalBio has a generous and comprehensive benefits package that includes but is not limited to medical, dental, and vision as well as mental health resources, virtual and telehealth options, coaching, infertility treatment, parental leave and health savings accounts. We also offer flexible work schedules and flexible time off, which includes two extra “Arsenal Days of Rest” every quarter for employees to recharge.
We are committed to hiring the best talent from diverse backgrounds. A diverse workforce engenders richness of thought, creativity and discovery. We invite individuals who embrace intellectual achievement to bring their unique personal and professional journeys and together we will build transformative cell therapies for cancer patients.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
The estimated base salary offer for the preferred primary location of San Francisco Bay area ranges from $194,300 – $238,000. Salary ranges for other locations may vary from this range. Base pay offered may vary depending on job related knowledge, experience, education, and location.
To all recruitment agencies: ArsenalBio does not accept agency resumes. Please do not forward resumes to our jobs alias, or ArsenalBio employees. ArsenalBio is not responsible for any fees related to unsolicited resumes.
#J-18808-Ljbffr