Manager, IT Compliance

Location
San Francisco, CA, United States
Posted
Jul 12, 2018
Ref
2-1-3290-850-2018
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Summary:

This is a key position in the IT department responsible for ensuring the Information Technology is compliant with all applicable regulations including GLP, GCP, GMP, or SOX. This position will work with the compliance administrator to: a) complete all recurring compliance tasks, b) ensure all computer systems are evaluated, selected, implemented and maintained in compliance with the applicable regulations (GLP, GCP, GMP, or SOX) or IT SOPs that apply to those systems, and c) develop (or revise) those documents required to complete system validation, implementation projects, and management of change control as defined by Nektar QA or GCP/GLP Compliance. This position is also responsible for the revision and maintenance of applicable Nektar CSV and other IT SOPs as required. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Responsibilities:

Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives as well as an understanding of the business.
Reviews and signs off on those recurring documents that demonstrate Nektar's compliance with applicable regulations. Develops, analyses, or revises Validation Plans, Installation Qualification, Operational Qualification, Production Qualification, Validation Summary Reports, and other validation documentation as required. Develops system test scripts for non-validated systems based on the system requirements as defined by the assigned IT Project Manager and Business Partner.
Leads or contributes to Supplier Audits and IT Services Quality Agreements in conjunction with Nektar QA and GCP/GLP Compliance departments to ensure compliant supplier management.
May participate in internal audits of Nektar computerized GxP systems. Works with the CP/GLP Compliance and QA departments to identify and review validation processes and procedures and implements changes and/or improvements to meet appropriate regulatory requirements, internal policies and current industry practices. Revises and maintains IT SOPs to ensure a clear set of policies exist for managing Nektar systems. Identifies and implements systems to enable Nektar IT to more efficiently and effectively maintain compliance. Reviews project plans to ensure appropriate validation activities, support for program, and project deliverables. Directs other IT compliance staff and may direct contractors supporting validation execution and protocol/report preparation. Ensures that company and contracted staff are properly trained and follow validation policies and procedures. Fulfills the role of IT Change Manager, Document and Compliance Administrator as required. May have responsibility for providing regular performance feedback, development and coaching to direct reports.

Requirements:

A minimum of a Bachelor's degree in a scientific or engineering discipline is required. Equivalent experience may be accepted.
Minimum of 6 years of experience in the pharmaceutical manufacturing environment is required. A minimum of 3 years direct computer system validation experience is required.
Demonstrated expert knowledge of computer system validation principles including user requirements, specifications, equipment/utility/facility qualification, computer validation, and process validation.
Working knowledge of or hands-on experience with general production systems used in the manufacturing, testing and holding of non-sterile pharmaceutical products. Must possess a thorough understanding of GxPs, in addition to FDA and International requirements for computer validation and Part 11 / Annex 11 requirements.
Must possess a thorough understanding of current industry guidance, including GAMP 5.
Must have direct experience with computer validation and determining computer validation approach, including enterprise platforms systems as well as custom software projects.
Must have ability to comprehend technical information related to computer software, computer and network hardware, and the associated regulatory requirements relating to them.
Ability to present and defend validation data to a small group. Strong word processing and spreadsheet skills are required.
Good communication skills both oral and written are required. Must be able to demonstrate excellent customer service skills. Strong attention to detail regarding documentation is a must.
Must be well organized, and willing to work as part of a team. Auditing experience is a plus.

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.