Information Technology Compliance Administrator II

Location
San Francisco, CA, United States
Posted
Nov 03, 2020
Ref
5262-850-R
Hotbed
Biotech Bay
Required Education
High School or equivalent
Position Type
Full time
Position Overview

The IT Compliance Administrator is a key position within the Nektar IT organization whose primary responsibility is to assist IT management in ensuring the activities of the IT group are in compliance with SOX and cGxP control requirements.

The three primary duties this individual must fulfill to meet this responsibility are that of: a) Change Manager, b) SOX Administrator, c) Document Administrator. As part of each of these roles, this individual is charged establishing and communicating practices to manage cost and ensure continuity of services. As member of the IT team, this individual is also responsible to take a proactive posture to evolving procedures and practices to support new technology and change in business requirements. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Exercises judgement within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Works on assignments that are difficult, requiring judgment in resolving issues or in making recommendations. Acts independently on occasion, following established procedures or guidelines, making recommendations to management when unable to resolve issues.

In the role of Change Manager this individual:
  • Maintains multiple record types (log books, excel spreadsheets, physical documents, etc.) of all Change Requests (CRs), issuing new change request numbers to IT staff as requested;
  • Reviews all CRs for compliance with applicable SOX, cGxP and IT quality requirements, approving only those CRs that meet those requirements;
  • Provides guidance and assists IT staff to meet applicable requirements as time permits;
  • Ensures the Change Review Board (CRB) meets as required and all identified issues from the CRB are followed up on, and e) provides updates on the status of Open Change Requests to IT Management on a periodic basis.
In the role of Sox Administrator this individual:
  • Maintains, revises and issues the IT General Computer Controls (IT GCC) and associated tests for these IT GCC's on an annual basis based on input from annual SOX Testing, IT Management and external audit results;
  • Ensures the IT GCC's are performed throughout the year escalating to IT management as needed;
  • Maintains and organized the results of all IT GCCs to ensure accessibility is readily available to IT management at all times and as needed;
  • Assists in the preparation of IT GCCs, and e) performs extensive annual IT GCC testing and reviews results with Nektar internal audit, preparing follow-up procedures on internal audit recommendations.
In the role of Documentation Administrator this individual:
  • Maintains multiple record types (excel spreadsheets, document lifecycle versions, as well as physical and electronic copies, etc.) of all IT Quality Documents (ITQDs) including, but not limited to i) IT quality system level documents, ii) IT arrangements, iii) access forms, and iv) IT system level passwords;
  • Reviews all ITQDs for compliance with applicable SOX, cGxP and IT quality requirements, approving only those ITQDs that meet those requirements;
  • Provides guidance and assists IT staff to meet applicable ITQD requirements as time permits, and
  • Reviews and suggest revisions to ITQDs to help streamline IT operational efficiency. Other requirements of this position include: Performance and monitoring of certain daily IT systems such as backup tape media rotation and offsite storage, review of the IT monitoring system for low level non-critical alerts communicating those to the IT staff as appropriate and physical inspection of the server rooms to ensure that all audible and visual alarms are taken care of. Prepares IT policies, practices, procedures for the IT staff. May help develop policy management standards. Performs special projects as assigned. Performs other duties as assigned.
Requires a minimum of a High School diploma. A Bachelor's degree in a relevant discipline is preferred. Equivalent experience may be accepted. A minimum of 2 years industry experience is required. Must be a quick learner, team player, and possess outstanding organizational skills. Very good analytical and problem solving skills are required. Strong skills in computer applications (MS Office, Word, Excel, Project) are required. Great interpersonal skills, with a focus on listening and questioning skills are required. Must possess excellent oral and written communication skills. Must be able to follow instructions and work well in a team environment. Experience in the Pharmaceutical, Biotech or Medical Product industry is preferred. Excellent customer service skills are required. Must have an excellent understanding of IT, SOX, and cGxP terminology and concepts. Some understanding of application processing and system development control techniques and related auditing techniques is preferred. Must be familiar with system design, computer operations, disaster recovery, data security and program change control. Familiarity with authentication and authorization architectures is preferred. Familiarity with internal controls as related to financial systems or FDA-related policies is preferred. Must have the ability to formulate and express ideas relating to difficult and highly technical concepts. Knowledge of project management methodologies is preferred. Previous experience with system implementations is preferred. Must possess good planning, decision making and judgement skills.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.