Head of Quality & Compliance, Clinical Trial Services
- Woonsocket, RI
Reporting to the General Manager of CVS Health's new Clinical Trial Services division, the Head of Quality and Compliance will build and lead the quality organization and maintain all aspects of the Quality System at CVS Health Clinical Trial Services, providing strong expertise and leadership while maintaining compliance standards as the division grows, innovates and serves an increasingly diverse and demanding pharma and biologics client base.
Some of the key responsibilities for this role include:
• Develop, implement and communicate a clear strategic vision for quality to maximize value to the CVS Health's Clinical Trial Service Business clients while maintaining a strong independent role for compliance-related decisions.
• Establish comprehensive quality strategies, processes and systems that support collaboration and compliance across our Client's extended partner network.
• Build and lead world-class, data-centric and results-driven Quality and Compliance teams. Drive excellence, continuous improvement and agility, while simultaneously championing best practices implementation and compliance.
• Provide overall leadership for the Quality and Compliance function to establish compliant processes and systems that support collaboration
• Assure personnel, processes, documentation and quality standards meet expectations for pharma and biotech sponsors and patterns while maintaining compliance with applicable regulations and guidelines.
• 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
• Ensure the ongoing 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 to remediate any identified gaps.
• Foster an environment of collaboration, trust, quality, innovation and continuous improvement within the Quality organization and between other functional departments.
• Support the development and communication of new or enhanced policies and procedures leading to innovative and competitive yet fully compliant clinical operations.
• Build key external relationship and stay connected to the market to identify emerging trends, changes and best practices and redesign quality processes and practices accordingly.
• 15+ years' experience in contract research organizations, academic research organizations, health providers, pharmaceutical companies or other similar organization running clinical trials.
• 10+ years managerial experience in a Quality and/or Clinical Operations environment, with expert knowledge and hands-on experience with ensuring compliance with FDA, HHS, GCP and other standards and regulations applicable to clinical trials, along with an understanding of global quality standards and regulatory authority inspection trends.
• 5+ years specific experience around the quality, integrity and compliance aspects of managing investigator sites, building SOP's, overseeing protocol conduct and interacting directly with clinical personnel.
• Experience with both commercial and federally funded research.
• Established network with key external stakeholders (FDA, HHS, sponsors, CRO's) and demonstrated ability to leverage this connectedness to anticipate, proactively respond to and may be even influence trends and/or shifts in the external environment, policy decisions, etc.
• Experience building leading quality organizations, ideally from the ground up in a start-up context.
• Flair for hiring well-rounded quality leaders that can build trusted advisory relationships with key internal and external stakeholders. The ideal candidate comes with a followership.
• Proven ability to build, scale and maintain a state-of-the-art quality systems in a very dynamic, fast-growing, multi-tenant environment.
• Experience with preparing for and successfully managing regulatory and sponsor inspections.
• Energetic leader with a "roll up your sleeves" approach, capable of thriving in a fast-paced, fast-changing environment.
• A "builder" and "problem solver" mentality, with a strong bias for action and collaboration across swim lanes. A business partner, not an enforcer.
• Executive presence: s/he will be comfortable in the ExCom room, can influence and have an engaging leadership style. Confidence without arrogance.
Bachelor's degree in chemistry, biology, pharmacology or similar required
Master's 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.
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