Quality Audit Senior Manager - Clinical Trial Services

Job DescriptionCVS Clinical Trial Services, a new 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.The Quality Audit Senior Manager owns the CTS Quality Vendor Audit Program, which includes vendor risk assessments, risk-based auditing, and Quality oversight of vendors across all CTS business units, including Recruitment, Conduct, and Real World Evidence. This role will also support Sponsor/CRO qualifications and audits of CTS. The Sr. Manager, Quality is responsible for building partnerships across quality and business units within the CVS enterprise, identifying opportunities for enhanced collaboration, improved communication, and ways of furthering quality and compliance. As the Quality Senior Manager you will stay attuned to the advancements in quality, regulations and assist in positioning the company to remain competitive by defining, communicating and proposing initiatives for growth and expansion.What you'll do:● Manage the CTS Quality Vendor Audit Program● Support qualification of CTS by Clients (i.e., Sponsors, CROs), including but not limited to completion/review of qualification questionnaires and hosting of audits and quality document review meetings.● Support Internal audits and Regulatory Inspections● Collaborate with CTS business units to ensure inspection readiness and develop relevant storyboards● Serve as primary CTS Business Quality liaison, collaborating with Minute Clinic and Coram Quality and other business functions to ensure understanding of business requirements, to align on roles and responsibilities, to leverage synergies and efficiencies, and to enable open communication and management of risks ● Manage the cross connections amongst Minute Clinic, Coram and CTS Quality ● Review quality documents (policies, standard operating procedures (SOPs), work instructions, forms, templates, process maps) that support CTS business units, providing recommendations to ensure alignment with business/clinical needs, regulations, and industry standardsRequired Qualifications● 8+ years of quality experience within the pharmaceutical and/or biotechnical industry● 5+ years of experience overseeing vendor audit/qualification activities, to include 3+ years of GCP experienceCOVID 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 clinical research, GCP, ICH, and other regulations for pharmaceuticals● Proven capability in taking complex information and translating to logical workflows● Demonstrated Business acumen, strong written and oral communication skills, able to translate complex concepts across all levels of the organization● Experience in developing metrics, and identifying areas of continuous improvementsEducationBachelor's degree in applied sciences, healthcare, or related fieldBusiness OverviewAt CVS Health, we are joined in a common purpose: helping people on their path to better health. We are working to transform health care through innovations that make quality care more accessible, easier to use, less expensive and patient-focused. Working together and organizing around the individual, we are pioneering a new approach to total health that puts people at the heart. We strive to promote and sustain a culture of diversity, inclusion and belonging every day. CVS Health is an equal opportunity and affirmative action employer. We do not discriminate in recruiting, hiring or promotion based on race, ethnicity, sex/gender, sexual orientation, gender identity or expression, age, disability or protected veteran status or on any other basis or characteristic prohibited by applicable federal, state, or local law. We proudly support and encourage people with military experience (active, veterans, reservists and National Guard) as well as military spouses to apply for CVS Health job opportunities.

Created: 2025-11-15