Senior Manager, Quality and Compliance

We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time.

Position Summary
Empowering health care decisions through evidence-based insights. CVS Healthspire™ Life Sciences Solutions is committed to advancing clinical research by translating real-world data into actionable knowledge.

The Senior Manger Quality and Compliance will be responsible for leading critical multi-functional team activity to set the strategy and plans for embedding Quality and Compliance across the research units including Real World Evidence (RWE), Safety, Surveillance and Collaboration (SS&C), Recruitment, and others under development.  Owns accountability for implementing operational requirements for regulatory compliance, integrating quality measures and leading inspections and audits with Health Authority and Partners including hosting, managing, and responding to audit and inspection findings.

Key areas of responsibility include:
 

• Establishes and maintains programs, policies, and procedures, ensuring full compliance to all applicable Regional and Federal regulations, guidance, and laws.
• Design, implement and maintain systems and processes to ensure on-going training requirements for scientific and other research staff are met, tracked and available for audit.
• Facilitate, track and document Root Cause Analysis, Quality Event and CAPAs with study teams.
• Develops actionable insights derived from project management tools, data analysis, and stakeholder feedback to drive improvement.
• Applies advanced methods to proactively identify, oversee, design, and implement quality and compliance requirements throughout the life cycle of the study, including post-closure data retention and document management.
• Develops methodology for the optimal rollout and measurement of key metrics including processes and work instructions for escalation and internal/external reporting.
• Establishes key goals and targets for the team development of critical key indicators to ensure individual and departmental goals and objectives are consistently met.
• Owns quality requirements and agreements for ongoing compliance and performance of third-party vendors.
• Manage and influence cross-functional partners.

Required Qualifications

• 6 or more years of Clinical Trial Process and business via Retail Pharmacy / Clinical Background, major Pharma, or Clinical Research Organization
• 6 or more years of experience with broader healthcare industry landscape and issues among payors, pharmacies, and other care providers and their influence on Clinical Trials

Preferred Qualifications

• Experience working for an IRB
• Experience working within a PBM and/or Payer environment.

Education

• Bachelor’s degree required

Pay Range

The typical pay range for this role is:

This pay range represents the base hourly rate or base annual full-time salary for all positions in the job grade within which this position falls.  The actual base salary offer will depend on a variety of factors including experience, education, geography and other relevant factors.  This position is eligible for a CVS Health bonus, commission or short-term incentive program in addition to the base pay range listed above.  This position also includes an award target in the company’s equity award program. 
 

Our people fuel our future. Our teams reflect the customers, patients, members and communities we serve and we are committed to fostering a workplace where every colleague feels valued and that they belong.

Great benefits for great people

We take pride in offering a comprehensive and competitive mix of pay and benefits that reflects our commitment to our colleagues and their families.

Additional details about available benefits are provided during the application process and on Benefits Moments.

Qualified applicants with arrest or conviction records will be considered for employment in accordance with all federal, state and local laws.