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Manager, IT GxP CoE

Company: Alexion Pharmaceuticals,Inc
Location: New Haven
Posted on: September 13, 2020

Job Description:

Req Id  21590  - Posted  08/12/2020  -  United States  -  New Haven, CT  -  Information Technology

This individual will manage Service Delivery Managers and Service Operations Mangers (predominantly outsourced).Qualified candidates will have experience managing outsourced service providers to provide IT GxP project delivery, support and maintenance. This position will ensure adherence of provided IT Application Management Services to business as per agreed SLAs for Quality Systems. Coordinate planning, resourcing and execution with other functions. Manages day to day service operations. Ensures stability and integrity, operating mission critical applications and systems. Manages the GxP service delivery model with standardized services, processes and tools to provide efficient, high quality industrialized services.

As a Single point of Contact for the business this role involves developing and maintaining a systems roadmap for GxP Quality Systems aligned to the business objectives/requirements, driving the implementation of the defined roadmap and obtaining the process, data integrity and systems integration, compliance and efficiency required throughout the system lifecycle adhering to the application management service framework.

Business Partnership and Development

Identify, develop and manage strategic business relationships and gain a comprehensive understanding of business requirements.

Develop trust based relationships and drive business alignment and readiness for business capability area investment per business strategy

Manage a team (Managed Service Provider(s)) providing services to Quality unit

Meet minimum internal service targets towards the serviced business units

Assure system stability and integrity of all Quality systems in scope of the GxP COE

Partner with IT & business leadership and other key stakeholders to shape global business demand by defining high level IT service portfolios and ensure is provided to business

Define Forward facing service catalogue for Quality Tower

Define standard Service Level Agreements (SLAs)

Provide consulting and guidance through key initiatives ensuring effective alignment of IT investments with business requirements

Participates in business function leadership team meetings to represent IT in sharing and communicating IT services and capabilities

Own the global accountability for the success of the IT services(s) and Quality projects delivered to business in accordance with project goals, time scales and costs in compliance with relative methodologies

Ensure creation of IT solutions/service design matching high level designs and functional specifications to meet quality and performance requirements

Ensure appropriate operational service documentation is created and accepted by stakeholders

Proactively share knowledge of technology risks with business partners while partnering with relevant groups to ensure continuous improvement of IT services, application rationalization and efficient management of existing systems and operations, while meeting internal service targets

Identify opportunities for continuous service improvement

Manages “live” technical environments on a day to day basis

Monitor, measure, report and review performance of services and ensure IT meets business needs

Ensures appropriate operational service documentation is created and accepted by stakeholders

Ensure that transitioned service fulfil customers and internal IT service levels

Ensure components of standard services are sourced and delivered from a defined service catalogue

Leadership

Participate in and coordinate cross functional complex systems applications management

Ensure appropriate IT cross functional involvement in project/support teams for solutions.

Support the business to maximize utilization of currently implemented solutions.

Communicate with end-users on GxP applications capability to maximize use and efficiency

Coordinate with the various resources to ensure a timely implementation. Delivering progress report to the business unit and IT management teams.

Qualifications

5+ years progressive experience in Quality and/or GxP systems

Preferred experience working with the following systems:

Document Management systems

Trackwise

Change control

5+ years progressive experience Computer Systems Validation and GAMP5 experience

5+ years Project Management experience

5+ years IT Tools and processes as it relates to ITIL

5+ years Application Management & Configuration management

Education

BA/BS in Degree in an IT or Business related discipline .

*LI-DD1

Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) as well as the first and only approved complement inhibitor to treat atypical hemolytic uremic syndrome (aHUS), anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing several mid-to-late-stage therapies, including a second complement inhibitor, a copper-binding agent for Wilson disease and an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases as well as several early-stage therapies, including one for light chain (AL) amyloidosis and a second anti-FcRn therapy. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes' list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.

As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.

Keywords: Alexion Pharmaceuticals,Inc, New Haven , Manager, IT GxP CoE, Other , New Haven, Connecticut

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