USDM Life Sciences
Computer System Validation Lead
USDM Life Sciences, Redwood City, California, United States, 94061
About USDM
USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.
As part of the USDM team, you will have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?
Founded in Santa Barbara in 1999, USDM has grown into a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.
Nature and Scope of Job
USDM Life Sciences is seeking a Computer Systems Validation Lead to work with our client to implement and validate Veeva Systems.
Primary Responsibilities
Provide independent technical leadership and accountability for overall computer system validation efforts.
Generate, review, and approve base-level documents such as validation plans, URS, FRS, DS, and SOPs supporting Computerized System Validation/Assurance activities.
Generate, review/approve, and execute computer validation (IQ, OQ, and PQ) documentation for GxP systems.
Develop, implement, and maintain computer system validation-related controlled documents to support the initiation, validation, operation, and maintenance of GxP systems.
Perform gap analysis & necessary remediation efforts on current computer systems to ensure compliance with Part 11 and Annex 11.
Collaborate, lead, or participate in decision-making and recommend the best options for validating computer systems.
Perform system assessments based on version upgrades/release updates on SaaS/Cloud-based GxP systems and ensure all the required verification and validation efforts are performed per the assessments conducted.
Facilitate the computer system validation risk assessments, i.e., system-level, requirement-level, and system and Data Audit Trail assessments.
Additional Responsibilities
Assist with change controls, CAPAs, deviations, and exceptions required for system validation efforts.
Maintain close communication with stakeholders and team members to keep apprised of the impact of computer system needs on system validation, project validation status, and other relevant issues.
Collaborate with client-approved vendor personnel to coordinate validation efforts, including reviews/approvals of related validation deliverables, and ensure a successful validation lifecycle.
Develop or assist with business process deliverables such as process flows, data flows, user/operating procedures, work instructions, and forms for GxP computerized systems.
Perform Periodic System Reviews, ensuring the systems maintain their validated status.
Qualifications
Expertise in Computer System Validation (CSV), including generating, reviewing, and executing validation documentation (IQ, OQ, PQ).
Deep understanding of regulatory compliance, especially 21 CFR Part 11 and Annex 11.
Experience with SaaS/Cloud-based GxP systems and performing risk assessments.
Ability to provide technical leadership and manage stakeholder communication effectively.
Experience collaborating with vendors on validation efforts.
Skill in developing business process deliverables and maintaining system validation status.
Proficiency in managing change controls, CAPAs, and deviations.
Education & Certification
A Bachelor’s degree in Information Technology, Computer Science, Engineering, or a related field.
Working Conditions
The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.
Unless reasonable accommodations can be made, while performing this job the staff member shall:
Sit or stand at a desk in an environmentally controlled office environment for prolonged periods of time.
Constantly operate a computer and other office productivity machinery, such as a calculator, scanner, or printer.
Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
Travel onsite as needed.
Equal Opportunity Statement
USDM Life Sciences is an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Disclaimer
This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
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USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.
As part of the USDM team, you will have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?
Founded in Santa Barbara in 1999, USDM has grown into a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.
Nature and Scope of Job
USDM Life Sciences is seeking a Computer Systems Validation Lead to work with our client to implement and validate Veeva Systems.
Primary Responsibilities
Provide independent technical leadership and accountability for overall computer system validation efforts.
Generate, review, and approve base-level documents such as validation plans, URS, FRS, DS, and SOPs supporting Computerized System Validation/Assurance activities.
Generate, review/approve, and execute computer validation (IQ, OQ, and PQ) documentation for GxP systems.
Develop, implement, and maintain computer system validation-related controlled documents to support the initiation, validation, operation, and maintenance of GxP systems.
Perform gap analysis & necessary remediation efforts on current computer systems to ensure compliance with Part 11 and Annex 11.
Collaborate, lead, or participate in decision-making and recommend the best options for validating computer systems.
Perform system assessments based on version upgrades/release updates on SaaS/Cloud-based GxP systems and ensure all the required verification and validation efforts are performed per the assessments conducted.
Facilitate the computer system validation risk assessments, i.e., system-level, requirement-level, and system and Data Audit Trail assessments.
Additional Responsibilities
Assist with change controls, CAPAs, deviations, and exceptions required for system validation efforts.
Maintain close communication with stakeholders and team members to keep apprised of the impact of computer system needs on system validation, project validation status, and other relevant issues.
Collaborate with client-approved vendor personnel to coordinate validation efforts, including reviews/approvals of related validation deliverables, and ensure a successful validation lifecycle.
Develop or assist with business process deliverables such as process flows, data flows, user/operating procedures, work instructions, and forms for GxP computerized systems.
Perform Periodic System Reviews, ensuring the systems maintain their validated status.
Qualifications
Expertise in Computer System Validation (CSV), including generating, reviewing, and executing validation documentation (IQ, OQ, PQ).
Deep understanding of regulatory compliance, especially 21 CFR Part 11 and Annex 11.
Experience with SaaS/Cloud-based GxP systems and performing risk assessments.
Ability to provide technical leadership and manage stakeholder communication effectively.
Experience collaborating with vendors on validation efforts.
Skill in developing business process deliverables and maintaining system validation status.
Proficiency in managing change controls, CAPAs, and deviations.
Education & Certification
A Bachelor’s degree in Information Technology, Computer Science, Engineering, or a related field.
Working Conditions
The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.
Unless reasonable accommodations can be made, while performing this job the staff member shall:
Sit or stand at a desk in an environmentally controlled office environment for prolonged periods of time.
Constantly operate a computer and other office productivity machinery, such as a calculator, scanner, or printer.
Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
Travel onsite as needed.
Equal Opportunity Statement
USDM Life Sciences is an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Disclaimer
This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
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