Job Description

The Director will be critical new role on the Cystic Fibrosis Guidance and Patient Support (GPS) Operations team where you will play a meaningful role within the well-established in-house 100+ member GPS team and contribute to driving the success of the program. You will lead all aspects of Quality and Compliance in GPS, owning critical components including: patient consent & enrollment, strategy and execution of the GPS Assurance program as well as Adverse Event/Product Complaint processes. You will lead a small team of five: three full-time employees and two expanded workforce hires. As a subject matter expert, you will be responsible for playing a crucial role to support patients in the best way. You will report to the Senior Director of GPS Operations and be a member of the GPS Operations Leadership Team. This role is a hybrid position requiring three-days in-person in the Boston Office.

Key Responsibilities:

• Lead developing and executing the GPS Assurance Program to drive exceptional and effective internal processes to support a 100+ in-house Patient Support Specialist Team

• Act as the Subject Matter and Expert within GPS on all patient compliance issues including ownership of specific Work Instructions and Standard Operating Procedures

• Develop and track Key Performance Indicators for your Quality & Compliance team’s performance throughout the year in line with GPS goals

• Responsible for internal Assurance & Monitoring program:

  • Establish critical tools and systems for conducting a repeatable assurance & monitoring program over the GPS processes that creates a value add for the function

  • Work with GPS key stakeholders to identify risks and areas for process improvement

  • Develop and execute annual assurance plans that include internal audits, monitoring activities, external audits and consulting engagements

  • Oversee the execution of monitoring activities, quarterly GPS internal audits conducted by GPS Quality & Compliance team, and engage on external audits conducted by a vendor on behalf of Vertex

  • Ensure appropriate remediation steps are taken to address audit findings/observations of nonconformance; Responsible for adequate and timely closure of CAPAs generated from audits

  • Present findings to internal team and appropriate service providers (as needed)

• Lead the Patient Data Specialist Team responsible for enrolling patients into our program, ensuring compliance with enrollment criteria and ensuring data quality in patient accounts

• Oversees GPS Document Management strategy and maintenance including work instructions, standard operating procedures, and standard review processes

• Acts as the primary liaison with Legal, Compliance (Office of Business Integrity & Ethics) and Privacy on program compliance and consent issues.

• As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff

Education Level:

• MS or MBA preferred

• Bachelor’s degree required

Required Experience:

10 years of relevant experience in pharmaceutical patient support operations, quality monitoring, assurance, patient safety, compliance, etc., and at least 3 years of supervisor/people management experience or the equivalent combination of education and experience.

Required Knowledge/Skills:

• Impeccable attention to detail and organizational skills

• Broad and deep expertise in Pharmaceutical Sector Patient Support programs and Quality Systems as well as a strong understanding of industry standards and best practices

• History of Quality Assurance auditing of internal systems and vendors

• Advanced ability to effectively influence the outcome of the decision-making process

• Proven ability to manage projects of significant scope and complexity, while meeting deliverables and timelines

• Strategic, critical and analytical thinking

• Strong technical writing, presentation and communication skills to persuade others to take action

• Extensive experience with external audit related activities including readiness, hosting, development of audit responses and other communications

• Extensive experience conducting investigations and audits, performing Root Cause Analysis and identifying CAPAs

• 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

• Willingness to work in a fast-paced environment and can multi-task and self-prioritize workload

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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