Publicidad

Lo sentimos, la oferta no está disponible,
pero puedes realizar una nueva búsqueda o explorar ofertas similares:

Sr Product Manager / Owner (Southern Ca Based )

ABOUT US: Hiring: Senior Product Owner . Our client, a privately-owned company that has been in business since 2009 is currently ranked in the top 5 in o...


Zacapa

Publicado a month ago

Data Engineer (Analyst/Programmer- Career)

Position Summary The mission of San Diego State University’s Analytic Studies & Institutional Research (ASIR) is to broadly support Academic Affairs includi...


Zacapa

Publicado 21 days ago

Senior Rf Design Engineer

The Company Silvus is a rapidly-growing high-tech entrepreneurial company in the heart of West Los Angeles. The company delivers the most technologically ...


Desde Silvustechnologies - Zacapa

Publicado 22 days ago

Soporte Técnico

Cartones de Guatemala Líder en la fabricación y comercialización de cajas de cartón corrugado cumpliendo con los requerimientos del cliente y mejorando cont...


Desde Cartones De Guatemala - Guatemala

Publicado a month ago

Associate Director, It Business Partner, Gxp Systems

Publicidad
Publicidad
Associate Director, It Business Partner, Gxp Systems
Empresa:

Halozyme


Publicidad

Associate Director, It Business Partner, Gxp Systems

Publicidad

Detalles de la oferta

Save time and apply through your LinkedIn account. Click the Apply with LinkedIn button and your LinkedIn profile will be imported into our site.

In order to move forward, you will need to create an account. Your password must be eight characters long, contain at least one special character, one capital letter and a number.

We look forward to discovering your talents.

POSITION SUMMARY:
The Associate Director, IT Business Partner for GxP Systems will be a strategic technology partner supporting designated teams to align technology direction to business goals and needs. This role defines key processes and requirements, creates technology roadmaps, acts as subject matter authority for technology-related processes and systems, leads technology partners, ensures appropriate level of compliance, and provides technology leadership and project management for technological projects.
This role is responsible for the information technology strategic direction in partnership with functional leadership (Quality, Regulatory, Drug Safety, etc.) focusing on building out capabilities of existing platforms.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
Partner with senior IT leadership in developing-an IT strategic plan for assigned client businesses and gain alignment on timing for investments on new business capabilities; ensuring that technology architecture, applications, processes, support operations and governance are aligned to strategic business initiatives
Finds opportunities where existing platform capabilities can align with IT strategy for functional leadership business goals
Lead efforts to ensure IT GxP compliance requirements are accurately assessed and implemented for both new solutions and improvements to existing systems
Partner with Quality systems validation and compliance resources
Lead external vendors to deliver complaint services and solutions on time and on budget
Lead the negotiation of requirements across multiple stakeholders and translate those requirements into functional requirements
Lead the prioritization of business deliverables to align with finite resources and/or business critical completion dates
Lead business case for IT investments and assist in preparation/presentation to business leaders and potentially the Executive Team
Support and improve SaaS solutions and on-premise solutions
Manage client business expectations ensuring they are being met through delivery of services or projects

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:

Minimum of Bachelor’s degree in computer science or information systems or related field required with at least 10 years of IT experience in Life Sciences (Biotech, Pharmaceuticals, Medical Device) industry (an equivalent combination of education and experience may be considered)
Experience with implementation of solutions with a focus on compliance GxP is required
Seasoned experience with IT Change Control to ensure GxP systems remain complaint thru support process
Demonstrated ability to partner with business team leaders and build alignment on technology investment
Experience with Quality, Regulatory and functions with GxP requirements
Lead and manage diverse IT resources to deliver business platforms
Demonstrated ability to successfully lead high-profile, sophisticated projects and implement third party solutions with minimum disruption to business
Experience with implementing, and enhancing Veeva’s technology platform; bring to bear Veeva’s various service offerings
Demonstrated ability to quickly adapt and apply new technical knowledge based on departmental and corporate goals and objectives, work successfully in cross functional teams, effectively identify problems, and develop flexible, scalable, and efficient solutions
Strong technical knowledge and practical experience in defining, implementing, and leading business and technical solutions
Strong written and oral communication skills, possessing the ability to communicate at both a technical level as well as at a business subject area level
Experience with technical implications of supporting GxP requirements

TECHNICAL KNOWLEDGE REQUIRED:
Equipment: PC’s scanners, facsimile machines, voice mail and email systems and common office machines, or ability to be trained. Knowledge of other equipment required: N/A

Software Knowledge:
Knowledge of technologies critical to biotech organizations including key technologies supporting Quality Management Systems, Regulatory Submissions, Information and Publishing, Drug Safety case management and reporting, Manufacturing/Supply Chain and Document Management
Veeva R&D platform
Oracle ARGUS safety platform
Experience with tools, technologies, and approaches to building, supporting and business reporting and analytics

INTERNAL AND EXTERNAL RELATIONSHIPS:
Quality
Regulatory
Drug Safety
Product Development
Bioanalytical
Manufacturing and Supply Chain
IT Infrastructure
Establish close relationships with key solution vendors as well as technology services vendors to improve vendor service levels and responsiveness

EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS:
Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting to20lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

Laboratory Activities, if applicable:N/A

TRAVEL:
N/A

Requisitos

Publicidad

Built at: 2021-07-28T23:28:06.665Z