Patient Support Quality Assurance Sr. Manager

Job Description

Vertex is looking to hire a Quality Assurance Senior Manager to join our Heme Patient Experience and Customer Operations (PECO) team. The PECO team is a group of compassionate and determined individuals who provide personalized reimbursement, educational, and ongoing product support for patients who have been prescribed treatment with Casgevy and enroll in the Vertex Connects Patient Support Program, as well as logistical product support to HCPs at Authorized Treatment Centers (ATC). PECO is comprised of four integrated teams: (1) Patient Support Operations, (2) Apheresis Operations, (3) Communications, and (4) Digital Strategy.

In this role, you will be a part of the Patient Support Operations, Quality and Compliance team, where you will contribute to the success of our programs, leading many aspects of the PECO Quality Assurance activities across PECO. As a subject matter expert, you will be responsible for playing a crucial role to ensure our team support's patients and HCPs in the best way, compliantly.

This role is based onsite at our Boston Seaport office (hybrid 3 days in office) and will report to the Associate Director of Quality & Compliance.

Key Responsibilities:

• Contribute to PECO audit readiness activities to ensure team is set up for success during internal or external audits, whether conducted directly by Vertex personnel or by an external vendor or regulatory agency
• Responsible for maintaining and executing internal PECO audit program:
  • Maintain risk assessment framework to support monitoring activities for active programs and Casgevy
  • Conduct periodic reviews of communications and business processes to ensure Vertex Connects Patient Support Programs and Casgevy Order Management programs are adherent to approved policies and procedures
  • Work closely with PECO stakeholders to ensure appropriate steps are taken to address Quality and Compliance audit findings and observations of nonconformance; ensures adequate and timely closure of CAPAs generated from audits
  • Utilize metrics and analytics to provide insight into process adherence, assess skill gaps and inform appropriate and meaningful training programs (liaise with Commercial Training)
• Lead for GPS on internal audits conducted directly by Vertex personnel; oversees and engages on external audits conducted by a vendor on behalf of Vertex
• Collaborate with cross-functional partners to represent PECO Quality Assurance activities
• Support Associate Director in providing insights and trends related to PECO Compliance Events and/or monitoring activities to Vertex Legal, OBIE and/or PECO leadership, as needed
• Identify and support process improvement activities
• Actively and consistently provides positive contributions to PECO team culture
• Act in complete and total compliance with all laws, regulations, and Vertex policies

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 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.

Desired Qualifications:

• Experience in patient focused programs within associated HIPAA regulations and other legal parameters and patient privacy policies Patient-centric and customer service minded
• Experience in Patient Support organizations
• Willingness to work in a fast-paced environment, and can multi-task and self-prioritize workload
• Attention to detail and committed follow-through in communication to internal and external partners
• Excellent written communication skills, presentation delivery as well as strong interpersonal skills

Flex Designation:

Flex Eligibility Status:

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com