USDM Life Sciences
Sr. Veeva Quality Suite - Validation Engineer
USDM Life Sciences, Redwood City, California, United States, 94061
Sr. Veeva Quality Suite - Validation Engineer
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About USDM Life Sciences 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 have the opportunity to work with cutting-edge technologies through our 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. Founded in Santa Barbara in 1999, USDM has grown to a global company with 300+ remote employees and offices throughout the US, Canada, and Germany.
Nature and Scope of Job The ideal candidate must have experience implementing and validating Veeva Quality Suite (Veeva QMS, QualityDocs), Veeva RIM, and Veeva Submissions.
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.
Assist with change controls, CAPAs, deviations, and exceptions required for system validation efforts.
Perform gap analysis and remediation 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.
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.
Perform system assessments based on version upgrades/release updates on SaaS/Cloud-based GxP systems and ensure all required verification and validation efforts are performed per assessments conducted.
Facilitate computer system validation risk assessments, including system-level, requirement-level, and data audit trail assessments.
Develop or assist with business process deliverables such as process flows, data flows, user/operating procedures, work instructions, and forms for GxP computerized systems.
Additional Responsibilities
Performs other related duties and assignments as required
Qualifications
Experience in Veeva Quality Suite Implementation, preferably experience with Veeva QMS, QualityDocs, Veeva RIM, and Veeva Submissions. Minimum 7+ years working experience in Pharmaceutical/biotech industries. Experience in FDA regulated industry and familiarity with CFR 21 Part 11, cGMP.
Must be able to work independently
Education & Certifications
Bachelor’s degree in Computer Science or Information Systems or related field.
Master’s Degree preferred
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:
Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
Operate 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.
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.
Compensation Salary/Hourly Rate Range (W2): USD 75.00 - 90.00
The base salary/hourly rate range represents the anticipated low and high end of the USDM’s compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate’s qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market data or budget.
Note All employees are eligible for USDM\'s rewards and recognition program. For more details about our benefits, visit us here: https://usdm.com/careers
Referral notes: Referrals increase your chances of interviewing at USDM Life Sciences.
#J-18808-Ljbffr
About USDM Life Sciences 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 have the opportunity to work with cutting-edge technologies through our 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. Founded in Santa Barbara in 1999, USDM has grown to a global company with 300+ remote employees and offices throughout the US, Canada, and Germany.
Nature and Scope of Job The ideal candidate must have experience implementing and validating Veeva Quality Suite (Veeva QMS, QualityDocs), Veeva RIM, and Veeva Submissions.
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.
Assist with change controls, CAPAs, deviations, and exceptions required for system validation efforts.
Perform gap analysis and remediation 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.
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.
Perform system assessments based on version upgrades/release updates on SaaS/Cloud-based GxP systems and ensure all required verification and validation efforts are performed per assessments conducted.
Facilitate computer system validation risk assessments, including system-level, requirement-level, and data audit trail assessments.
Develop or assist with business process deliverables such as process flows, data flows, user/operating procedures, work instructions, and forms for GxP computerized systems.
Additional Responsibilities
Performs other related duties and assignments as required
Qualifications
Experience in Veeva Quality Suite Implementation, preferably experience with Veeva QMS, QualityDocs, Veeva RIM, and Veeva Submissions. Minimum 7+ years working experience in Pharmaceutical/biotech industries. Experience in FDA regulated industry and familiarity with CFR 21 Part 11, cGMP.
Must be able to work independently
Education & Certifications
Bachelor’s degree in Computer Science or Information Systems or related field.
Master’s Degree preferred
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:
Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
Operate 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.
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.
Compensation Salary/Hourly Rate Range (W2): USD 75.00 - 90.00
The base salary/hourly rate range represents the anticipated low and high end of the USDM’s compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate’s qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market data or budget.
Note All employees are eligible for USDM\'s rewards and recognition program. For more details about our benefits, visit us here: https://usdm.com/careers
Referral notes: Referrals increase your chances of interviewing at USDM Life Sciences.
#J-18808-Ljbffr