Quality Manager Computer System Validation - Clinical ...

Job DescriptionCVS Clinical Trial Services, a CVS Health company, is part of the company's portfolio of initiatives to advance and transform health and healthcare. As we redesign and innovate trial delivery and real-world evidence generation, we put the patient at the heart of everything we do. We are a dynamic team who have the benefit of operating in an entrepreneurial environment where bold thinking and novel approaches are not only rewarded, but they are also encouraged. Ownership and the ability to shape the way forward is empowered at all levels to accelerate progress and innovation. Here, colleagues work not only within our organization but across the CVS Health matrix, acting as one team to achieve our goals, deliver solutions and transform the future.As Quality Manager Computer System Validation, you will be responsible for providing Quality support and oversight for Computer System Validation (CSV) initiatives, as well as on-going change control and periodic review of implemented systems at CVS Health Clinical Trial Services (CTS). This role will also support the Quality Management team by leading Quality improvement efforts and supporting Quality SOP development. In this role, you will provide support all CTS teams (i.e., Clinical Trial Conduct, Real World Evidence (RWE), Safety Surveillance and Collaboration, and Patient Recruitment).What you'll do: Serve as Quality representative for the CTS Computer System Review Committee, providing risk-based Quality guidance regarding computer system validation efforts Review and provide input for Computer System Risk Assessments and other applicable validation deliverables Participate in change control activities for implemented systems, ensuring systems remain in a compliant state throughout their lifecycle Conduct periodic evaluations of implemented systems Review and provide feedback on CSV/SDLC SOPs, Work Instructions, Forms, Templates Support Computer System Validation team in maintaining a state of inspection readiness Participate in project team meetings, department meetings, and other meetings as applicable Support computer system-related Quality Events, CAPA, deviations Conduct and/or support audits of GxP software vendors Support the Quality Management System by leading Quality improvement efforts and implementation of new Quality processes Maintain a thorough knowledge of appropriate regulations and standard operating procedures Support Customer audits and Regulatory inspections Perform other related duties as assigned from time to time based on company needs.Pay RangeThe typical pay range for this role is:Minimum: 60,300Maximum: 126,600Please keep in mind that this range represents the pay range for all positions in the job grade within which this position falls. The actual salary offer will take into account a wide range of factors, including location.Required Qualifications 5 years' experience in GxP computer system validation in the biotech and/or pharmaceutical industry 5 years' experience supporting a Quality Management System in the biotech and/or pharmaceutical industry 3 years' experience developing Quality policies and proceduresCOVID RequirementsCOVID-19 Vaccination RequirementCVS Health requires certain colleagues to be fully vaccinated against COVID-19 (including any booster shots if required), where allowable under the law, unless they are approved for a reasonable accommodation based on disability, medical condition, religious belief, or other legally recognized reasons that prevents them from being vaccinated. You are required to have received at least one COVID-19 shot prior to your first day of employment and to provide proof of your vaccination status or apply for a reasonable accommodation within the first 10 days of your employment. Please note that in some states and roles, you may be required to provide proof of full vaccination or an approved reasonable accommodation before you can begin to actively work.Preferred Qualifications Comprehensive knowledge of regulatory requirements and industry best practices with respect to computerized systems and data integrity (e.g., GCP, 21 CFR Part 11, Annex 11, ICH E6, GAMP5) Ability to communicate regulations and requirements to internal teams Experience leading successful continuous process improvement initiatives Efficient and skilled in writing and developing documents using Microsoft office Demonstrated Business acumen, strong written and oral communication skills, able to translate complex concepts across all levels of the organizationEducationBachelor's degree or equivalent work experienceBusiness OverviewBring your heart to CVS HealthEvery one of us at CVS Health shares a single, clear purpose: Bringing our heart to every moment of your health. This purpose guides our commitment to deliver enhanced human-centric health care for a rapidly changing world. Anchored in our brand - with heart at its center - our purpose sends a personal message that how we deliver our services is just as important as what we deliver.Our Heart At Work Behaviors support this purpose. We want everyone who works at CVS Health to feel empowered by the role they play in transforming our culture and accelerating our ability to innovate and deliver solutions to make health care more personal, convenient and affordable. We strive to promote and sustain a culture of diversity, inclusion and belonging every day. CVS Health is an affirmative action employer, and is an equal opportunity employer, as are the physician-owned businesses for which CVS Health provides management services. We do not discriminate in recruiting, hiring, promotion, or any other personnel action based on race, ethnicity, color, national origin, sex/gender, sexual orientation, gender identity or expression, religion, age, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Created: 2025-11-01