Patient Safety Quality, Stnds & Training Specialist

Vertex Pharmaceuticals • Boston, MA

3d • Remote

About The Position

The Patient Safety Quality, Standards and Training (QST) Specialist is responsible for participating in the development, implementation and/or maintenance of relevant quality initiatives and compliance activities supporting Global Patient Safety (GPS).

Requirements

• Sound ability to communicate effectively in a matrix environment
• Solid written and oral communication skills
• Sound attention to detail
• Displays ability to understand established procedures and communicate those procedures to others
• Demonstrates a basic understanding of quality and regulatory compliance as well as application of these concepts to Pharmacovigilance
• Effectively communicates issues regarding quality or compliance concerns to internal and external stakeholders
• Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint)
• Bachelor's degree in a scientific or allied health field (or equivalent degree)
• Typically requires 2 year of experience or the equivalent combination of education and experience

Responsibilities

• Participates in the implementation of quality and compliance activities within GPS. These activities include, but are not limited to, the following: training, GPS deviation investigation management, GPS Corrective Action Preventative Action (CAPA) management, GPS documentation quality review, GPS document management, and Audit/Inspection Readiness
• Contributes to the Pharmacovigilance System Master File (PSMF) as assigned
• Helps to facilitate and provide quality insight into GPS deviation investigations and CAPAs
• Reviews and maintains Pharmacovigilance Agreements and Contracts and coordinates associated relationships with Vendors/Business Partners as assigned
• Contributes to the development and the review of Standard Operating Procedures and Work Instructions
• Helps to create and conduct presentations of quality or compliance issues, initiatives and projects
• Collaborates with stakeholders in the remediation of identified compliance risks
• Generates and presents quality metrics to management and other stakeholders
• Works collaboratively to ensure completion of quality and compliance initiatives
• Provides support, as requested, in the preparation, facilitation, and close-out of audits and inspections
• Responsible for supporting management with inspection readiness activities
• Participates in safety-related projects/teams as assigned
• Provides support to all GPS business units, as requested

Benefits

• This role is eligible for an annual bonus and annual equity awards.
• Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.
• At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.
• From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees