Title: Director, Regulatory Affairs & Patient Safety
Hub Locations: Atlanta, GA; Columbus, OH; Dallas, TX; Richmond, VA
Remote/Onsite/Hybrid: REMOTE
Industry Experience Required: healthcare, pharmaceuticals, or regulated environment
Purpose:
The Director, Regulatory Affairs & Patient Safety is entrusted with managing the Enterprise Quality Management approach to regulatory intelligence at the state and federal levels while focusing on patient safety. This role demands exceptional leadership in a dynamic matrixed environment, exemplary communication skills, and a strategic vision to ensure regulatory compliance, uphold program integrity, and foster continuous improvement. Additionally, you will lend your expertise to bolster the licensing team.
Scope of Responsibilities
This role will include the support of ongoing programs and the development and facilitation of the delivery of an expanded line of products, services, and insights that transform the patient and provider experience from a regulatory affairs and patient safety perspective.
Responsibilities for the Director, Regulatory Affairs & Patient Safety include, but are not limited to:
- Enhance McKesson’s pharmacovigilance oversight to ensure compliance with federal regulations and contractual obligations. Analyze trends to enhance performance and compliance in pharmacovigilance operations and develop and maintain training programs and materials specific to pharmacovigilance processes. Ensure accurate reporting of adverse events and non-conformance issues, upholding quality assurance standards.
- As part of the regulatory intelligence leadership, navigate the regulatory landscape by monitoring, interpreting, and enhancing our regulatory intelligence capabilities to make informed strategic decisions and ensure compliance across the McKesson enterprise.
- In terms of regulatory and industry practices, stay current with applicable regulations and industry practices, providing updates to business areas and updating procedures and practices to align with regulations and industry standards from BOP, FDA, ISO, EMA, and other relevant domestic and international entities
- For Recall Process Development and Management, oversee the development and harmonization of enterprise-wide management of product recall processes, ensuring swift and effective action when necessary.
- Quality and Safety Decision Facilitation, play a key role in designing and supporting an enterprise-wide quality review board to facilitate informed decisions regarding product quality and patient safety at the appropriate levels.
- Drive a culture that focuses on Quality and Compliance. Ensure adherence to quality assurance standards and regulatory requirements, aligned with the Enterprise-Wide Quality Operating Committee Charter while leading initiatives to improve technology, and customer satisfaction.
- Participate in activities associated with assisting the business units meet DSCSA requirements through engagement with the suspect and illegitimate, and exception processes while facilitating inspection readiness status.
- Participate in activities and projects associated with expanding the capabilities and process of the licensing team.
- To support the McKesson Business Units, collaborate with business units to conduct thorough investigations of unexpected events, develop robust Corrective and Preventive Actions (CAPA), and monitor the effectiveness of these actions.
- Develop as a backup for the REMS Program Management which may include the maintenance and update of REMS programs, ensuring alignment with FDA requirements and Wholesale Distribution specifics, including the management of the audit documentation process, including submission, response, and closeout activities. As the legal quality liaison, we handle REMS product contract reviews and amendments, ensuring compliance with REMS requirements. Collaborate with business teams to coordinate new REMS product launches and training initiatives and conduct bi-annual user access portal reviews as necessary, ensuring accurate reporting and documentation.
- Other activities as needed to support the Enterprise Quality Management mission.
Qualifications/Requirements:
- Bachelor’s or advanced degree in a healthcare-related field is preferred.
- A minimum of 10 years of experience in healthcare, pharmaceuticals, or regulated environment
- Hands on, coaching, and motivated leader to drive risk reduction and business excellence.
- Demonstrated ability to influence across a matrix structure, and to collaborate in a cross-functional environment.
- Highly organized and proficient in working in matrixed organizations to support business and program needs.
- Provides motivational leadership to the organization and improves its performance.
- Strong problem-solver and business acumen. Understanding of quality improvement using tools such as Six Sigma, Lean and FMEA.
- Strong interpersonal, verbal and written communication skills, organizational and workload planning skills along with the ability to manage multiple different projects simultaneously.
This position is integral to ensuring that McKesson remains a leader in providing compliant and effective healthcare solutions. Join McKesson’s Enterprise Quality Management team as we continue to innovate and enhance the healthcare landscape, ensuring that our patients receive the safest and most effective therapies available.
Must be authorized to work in the US. Sponsorship is not available for this position.
