The Head of Quality and Compliance for CVS Clinical Trial Services will proactively assess compliance risks in Clinical Trial Services, providing strong leadership expertise while maintaining compliance standards
Establish comprehensive quality processes and systems that support collaboration and compliance across an extended partner network
Develop, implements and communicates a clear strategic vision for quality to maximize employee focus, while maintaining a strong independent role for compliance-related decisions
Review existing policies and procedures, identifies gaps, and supports the development and communication of new and enhanced policies and procedures leading to compliant operations
Provide overall leadership for the Quality and Compliance function to establish compliant processes and systems that support collaboration.
Maintain clinical compliance while remaining commercially competitive
Assure personnel, processes, documentation and quality standards meet expectations for BioPharma sponsors and patterns while maintaining compliance with applicable regulations and guidelines.
Formulate quality and compliance policies in coordination with corporate management and ensures that all required systems and standard operating procedures are in place and current.
Ensure monitoring and auditing of CVS Clinical Trial Services operations to identify potential compliance risk areas; recommends and assists with the implementation of enhancements to existing policies and procedures and other corrective actions.
Foster an environment of collaboration, trust, quality, innovation and continuous improvement within the Quality organization and between other functional departments.
Identify and assess Clinical Trial Services quality risks and ensures they are evaluated and managed appropriately in order to accomplish both business goals and regulatory and quality requirements
Identify emerging trends/changes and redesign processes and practices accordingly.
Select, develop, and evaluate personnel to ensure the efficient operation of the R&D QA department
Establish, implement, and maintain performance metrics.
Develop strategic plans to ensure successful implementation of objectives where analysis of situations or data requires an in-depth knowledge of the company, competitive environment, technology, economic, or social implications of organization activities
Participate in development of corporate methods, techniques and evaluation criteria for projects, programs, and people
Develop a robust development quality system, provides business level leadership, and fosters best practices across the organization
15+ years experience in the pharmaceutical or other related industry with at least 10 years of management experience
15+ years working experience in a Quality and/or Clinical Operations environment with expert knowledge and hands-on experience with GCP & GLP audits.
Comprehensive knowledge of GCP, GLP and other regulations for pharmaceuticals, along with an understanding of global quality standards and regulatory authority inspection trends in relation to product development, submission and commercialization.
Understanding of all aspects of the pharmaceutical business, from research through sales and marketing, with the ability to operate cross-functionally and/or globally to achieve CVS goals.
Demonstrated ability to provide leadership for key strategic issues and significant quality policies, practices, and processes with respect to quality compliance.
Experience with preparing for and successfully managing regulatory and sponsor inspections.
Demonstrated ability to anticipate, proactively respond to trends and/or shifts in the external environment (e.g., regulatory, business partner relationships, industry standards).
Excellent strategic skills with the ability to influence decisions at a senior level, both internally and externally.
Bachelors degree required
Masters degree preferred
At 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.