Senior Manager, Program Quality

Job Description

General Summary:

Vertex is looking to hire a Senior Manager, Program Quality, to join our US Patient Support Center of Excellence (COE).  The COE is a group of compassionate and determined individuals who provide operational support to our three commercial Patient Support teams (Cystic Fibrosis, Hematology, and Acute Pain) including support in systems and technology, data and analytics, vendor management and program quality. Additionally, COE team members help design patient support offerings and policies for future Vertex Patient Support Programs (PSP).  

As the Senior Manager you will be a part of our Program Quality team, where you will play a meaningful role within the COE and contribute to the success of the PSP programs. You will lead aspects of Compliance in GPS. As a subject matter expert, you will be responsible for playing a crucial role in monitoring and auditing compliance to the PSP policies as well as tracking corrective and preventative actions. You will report to the Director of Program Quality in the COE.

Key Responsibilities:

• Manage internal PSP audit programs; utilize metrics and analytics to provide insight into process adherence, assess skill gaps and ultimately inform appropriate and meaningful training programs (liaise with Commercial Training)
• In concert with technological tools, conduct monthly communication monitoring (e.g. calls, texts, emails) of PSP engagement, analyze data trends, and recommend areas of improvement

• Establish and support GXP Event Management processes including quality and compliance standards, processes and measurement systems, including for Hematology and building out processes, standards and systems for T1D

• Responsible for audit of external PSP vendors; lead assessment, present findings, and track outcomes & deliverables
• Lead for PSP on internal audits conducted directly by Vertex personnel; oversee and engage on external audits conducted by a vendor on behalf of Vertex
• Presents findings to internal team and appropriate service providers (as needed)
• Work closely with GPS stakeholders to ensure appropriate steps are taken to address audit findings/observations of nonconformance; ensures adequate and timely closure of CAPAs generated from audits
• Act as the Privacy and Compliance champion to support an expanded Patient Support Specialist/Care Manager Team of varying tenure and experience
• Manage current and future cross-functional projects that improve processes that support the multilayered Patient Services Team (e.g. guidance regarding community events, creating a template of shared resources between the Patient Services Team and the field)
• As directed by the Director, liaise with the office of Business Integrity & Ethics, Legal, Privacy Office and other field facing teams to proactively enhance how our cross-functional teams can appropriately interact together and with external stakeholders; ensure guidance is clear, up to date, and pulled through.
• Identify opportunities for operational efficiencies and continuous improvement and partner with colleagues in other disease areas to share learnings / best practices

Minimum Qualifications

• A Bachelor’s degree with 5+ year’s pharmaceutical/biotech industry experience
• Experience working in a Quality or Compliance role or relevant comparable background in Patient Support preferred
• Intellectually curious with a continuous improvement mindset; high customer service aptitude, seeks to understand and self-educate on current trends in patient services quality programs
• Understands how systems and databases are structured, has the ability to consolidate multiple data sources, and synthesize large datasets into key findings and recommendations. 

Preferred Qualifications:

• Experience in patient focused programs within associated HIPAA regulations and other legal parameters and patient privacy policies Patient-centric and customer service minded
• Product Launch experience of drugs with complex service models
• Willingness to work in a fast pace environment, and have the ability to multi-task and self-prioritize workload
• Attention to detail, highly organized and committed follow-through in communication to internal and external partners
• Ability to work independently yet function as a team player and experience collaborating offline and managing formal reviews with legal, compliance, marketing
• Contributes to Vertex’s culture of compliance by focusing on ethics and integrity in all interactions and ability to role model the expected behavior for the team
• Excellent communication skills, both written and verbal, with the ability to connect effec