Quality Lead / Senior Validation Engineer
Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines & Values :
- We empower and support our colleagues
- We commit to client success at every turn
- We have the courage to do the right thing
- We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
- We constantly acquire new skills and learn from our experiences to enhance our collective expertise
Quality Lead / Senior Validation Engineer Responsibilities :
This position will be responsible for supporting the Quality Information Systems Management group, working closely with operational functions and other business and QA groups to facilitate regulatory assessments, change control review requirements gathering, design, and system testing. This role will perform quality oversight functions and take quality ownership for all related computerized system projects.
Job Responsibilities :
Provide Quality oversight and system proficiency with Enterprise computerized systems- ServiceNow, QMS, ERP, Veeva EDC, Compass, RIM, Data analytics platforms, Lab Systems, and Manufacturing SystemsTake Quality ownership - participate in cross-functional team discussions, provide quality guidance / decisions for the projects that include new implementation, enhancements, quarterly releases, periodic reviewsReview and approve quality events (deviations & CAPAs), etc.Participate and drive system assessments - review and approve project deliverables, including plans, test scripts, execution and its outcome, reports, and traceabilityParticipate and drive the discussions on issues to resolutions, adhering to quality complianceHighlight any identified quality risks and present possible mitigation options to the project team, and keep them informed of the quality managementPerform, evaluate, and communicate thorough quality assurance at every stage of systems development / implementationJob Requirements :
Bachelor's degree in IT or Computer Science5+ years of proven experience with computerized systems, Enterprise Level and Lab systems in the validation / quality spaceFamiliarity with ITIL / GAMP5 Validation LifecyclePractical experience generating process documentation and reportsExcellent communication skills with the ability to translate data into actionable insightsStrong working knowledge of relevant computerized systems module, structure designProven capabilities in project and user-testing managementProven development of innovative and impactful systems solutionsHighly proficient technical writing capabilitiesKnowledge of Agile validation lifecycle and methodologiesExperience with Veeva VQMS, ServiceNow and Application Lifecycle Management with e-signature (ALM) system is highly desirableNational (US) Range
$80,465 - $128,535 USD
Benefits
Why Choose Verista?
High growth potential and fast-paced organization with a people-focused cultureCompetitive pay plus performance-based incentive programsCompany-paid Life, Short-Term, and Long-Term Disability Insurance.Medical, Dental & Vision insurancesFSA, DCARE, Commuter BenefitsSupplemental Life, Hospital, Critical Illness and Legal InsuranceHealth Savings Account401(k) Retirement Plan (Employer Matching benefit)Paid Time Off (Rollover Option) and HolidaysAs Needed Sick TimeTuition ReimbursementTeam Social Activities (We have fun!)Employee RecognitionEmployee Referral ProgramPaid Parental Leave and BereavementVerista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details. For more information about our company, please visit us at