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ISS Support Analyst/Senior Support Analyst (Business System Owner) at GlaxoSmithKline

Posted in Health Care 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: Philadelphia, Pennsylvania

Job Description:



Position Title: ISS Support Analyst/Senior Support Analyst (Business System Owner)

Working Location: Pennsylvania

Employment Status: Full time

Required Experience: 2 years

Required Education: Bachelors

Travel Required: 0%

Job Description:

The role is to be the Business System Owner (BSO) for a system(s) which is used to support the clinical development process within R&D. The BSO is the named individual within a business area who has overall accountability for the computer system validation of each system in the business area that is used to assist a regulated process, e.g. the “good practice" quality guidelines and regulations (GxP) mandated by regulators and inspectorates. Within this accountability, they must ensure that the system is appropriately validated, used and maintained in a compliant manner, and is always ready for inspection by regulatory authorities. This includes GxP systems used or provided by third parties on GSK's behalf. They usually work in partnership with an IT Service Owner (SO), and through this they must ensure that the validation of their system shows that it has been planned, designed, built/installed, tested, released, operated, supported and decommissioned in compliance with all applicable laws/guidelines, GSK Policies and Procedures and contractual obligations. The BSO is also accountable for ensuring that each non-GxP system, under their ownership, has been appropriately tested and verified through the qualification of the system.

KEY RESPONSIBILITIES

1) Be accountable for maintaining the system in an inspection-ready state and validated according to the level of risk and GCP compliance required

2) Be responsible for maintaining System Audit/Assessment readiness and support

3) Partner with one or more cross-functional business groups to develop, standardize, improve and maintain business, technical and system functionality and processes to achieve business benefits

4) Serve as a point of contact for questions related to assigned functional area(s), assigned system(s) and areas of expertise for internal and external customers, as appropriate

5) Responsible for ensuring that their system’s functionality and performance are aligned to the business requirements set out by the assigned user group and delivered accordingly

6) Possess global view of system(s) and be able to represent implications of system changes

7) Ensure data integrity is maintained through all system versions

8) Understand the system landscape and the impact of changes in downstream systems

9) Possess knowledge of the System Development Life Cycle, especially in User Acceptance Testing

10) Display strong understanding of the needs of application support (e.g. enhancements versus bugs, scheduled downtimes versus unscheduled downtimes)

11) Possess knowledge of quality management, computer compliance, and computer system validation in a regulated environment

12) Ability to problem solve and think outside the box, while still adhering to regulatory requirements

13) Apply knowledge, experience and leadership skills in execution of job responsibilities

14) Be customer focused (i.e. know when to apply a sense of urgency, apply flexible thinking and strong communication skills)

15) Basic project planning skills

Essential Skills:

• Bachelors Degree in Computer Science, Math/Statistics, Life Sciences with 2-5 years of experience in a support services role.

• Ability to work effectively with inter-disciplinary teams

• Ability to work on complex and/or multiple project assignments

• Demonstrated ability to manage tasks proactively

• Exhibits enhanced customer service orientation and excellent interpersonal skills with ability to communicate professionally to diverse cross functional non-technical and technical audiences

• Solid technical background and computer proficiency

We are an Equal Opportunity Employer and do not discriminate against

any employee or applicant for employment because of race, color, sex,

age, national origin, religion, sexual orientation, gender identity,

status as a veteran, and basis of disability or any other federal,

state or local protected class.

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