CGI Technologies and Solutions, Inc. Infrastructure Qualification / Validation Manager in Haywood, California
Infrastructure Qualification / Validation Manager
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City:Haywood, California, United States
Employment Type:Full Time
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The Infrastructure Qualification/Validation Manager will use a risk-based approach to ensure IT Infrastructure meets GxP standards, where required. This includes internally hosted and managed infrastructure as well as external, such as SaaS and PaaS). This will be done using GDP, SOPs, Work Instructions, forms, internal audits, 3rd party audits and staff training. Where required, this position will also drive the Change Control, Deviation and CAPA process.
Function as Qualification Lead on multiple assigned infrastructure projects for hardware replacements, upgrades, patches and/or modifications to infrastructure needed to support quality systems and applications. Projects may include IAAS, PAAS, virtualization, and datacenter qualifications.
Develop strategy for the qualification aspects of the project, using risk-based approach to determine testing, documentation and verification activities, with appropriate justification of the approach.
As necessary, modify/create Qualification Plan, Protocols, and Test Plans, Risk / security Assessments, Reports, Trace Matrix and SOPs.
Manage qualification testing coordinating documentation and testing activities. Generate test scripts, as needed. Execute testing as required
Participate in and guide team in generating/modification Design / config. Specifications and network diagrams
Ensure qualification processes are executed as defined by procedures.
Support process of infrastructure change management and qualification procedures
Development of Standard Operating Procedures (SOPs)
Conduct internal audits to identify gaps.
Manage electronic routing of required documentationensuring compliance to current procedure for e-approval.
Communicate status, solutions and concerns. Disseminate information in a timely manner within the team. Facilitate and address issues within project.
Collaborate with vendor(s), quality, and technical individuals throughout project in generation of project / qualification required deliverables.
Represent Infrastructure during internal and regulatory audits, such as PAI.
Collaborate with Intarcia QA on above.
Required Qualifications / Experience:
Minimum BA / BS or relevant work experience in information systems, engineering, science or business.
Highly skilled in Computerized System infrastructure testing and validation in the healthcare industry. At least 8 years validation experience with infrastructure qualifications.
Proven results in managing qualification aspects of infrastructure.
Knowledge of International GxP regulations (e.g. 21 CFR Part 11, 211, 820, PIC/s), HIPAA, and privacy regulations affecting infrastructure security and compliance.
Experience with use of Electronic Records/Electronic Signatures and document management systems.
Experience working in a highly regulated FDA GxP environment
Experience with preparing for IT audits is desirable.
Solid project organizational skills. Ability to multi-task. Must have strong analytical problem solving skills.
Excellent communication including written, verbal, and listening skills.
Self-motivated, detail oriented, takes initiative and ability to work independently without close supervision.
Education / Certifications
Relevant Bachelor's degree in CS, MIS, Life Sciences, Engineering, Business; or equivalent experience.
What you can expect from us:
Build your career with us.
It is an extraordinary time to be in business. As digital transformation continues to accelerate, CGI is at the center of this changesupporting our clients digital journeys and offering our professionals exciting career opportunities.
At CGI, our success comes from the talent and commitment of our professionals. As one team, we share the challenges and rewards that come from growing our company, which reinforces our culture of ownership. All of our professionals benefit from the value we collectively create.
Be part of building one of the largest independent technology and business services firms in the world.
Learn more about CGI at www.cgi.com .
No unsolicited agency referrals please.
CGI is an equal opportunity employer.
Qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.
CGI provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job in the U.S., please email the CGI U.S. Employment Compliance mailbox at USEmploymentCompliance@cgi.com . You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned .
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All CGI offers of employment in the U.S. are contingent upon the ability to successfully complete a background investigation. Background investigation components can vary dependent upon specific assignment and/or level of US government security clearance held.
CGI will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with CGIs legal duty to furnish information.
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Applicants have rights under Federal Employment Laws:
EPPA at https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf
FMLA at https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
Consolidated EEO Is The Law at http://documents.njoyn.com/homebase/cgi/AMSDocs/EEO_Poster.pdf
CGI provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job in the U.S., please email the CGI U.S. Employment Compliance mailbox at USEmploymentCompliance@cgi.com . You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.
We make it easy to translate military experience and skills! Click here at http://cgi-veterans.jobs/ to be directed to our site that is dedicated to veterans and transitioning service members.