Quality Assurance Manager - Quality and Compliance (contract) 22394 - Vertex Pharmaceuticals

Vertex is looking to hire a Quality Assurance 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. You will lead 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. You will report to the Associate Director, Quality & Compliance.

Key Responsibilities:

• Support Associate Director in the management of PECO’s Quality Assurance program in partnership with key stakeholders to support multiple customer-facing teams of varying tenure and experience.
• 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.
• Conduct periodic communications and business process monitoring to ensure adherence to approved policies and procedures.
• Monitor Compliance Events, providing appropriate follow up actions, such writing State Disclosure Letters or completing Data Incident Investigations.
• Work closely with PECO stakeholders to ensure appropriate steps are taken to address audit findings/observations of nonconformance; ensures adequate and timely closure of CAPAs generated from audits
• 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
• 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.

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
• 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

$60-$70/hr

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

By applying for this position, you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials, which may include your CV/Resume, email address or phone number, with Vertex. For more information on how Vertex handles your personal data related to your job application, please see Vertex’s Careers Privacy Notice.   Agreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners

(collectively, “Atrium Alerts”). Atrium Alerts may be sent by email, phone, or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time, please contact Atrium at privacyadministrator@atriumstaff.com.

If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at tempstaffing@vrtx.com. Please include the job title in the subject of your email.

No C2C or Third-Party Vendors