Companies you'll love to work for

Specialist, Patient Safety Quality, Standards & Training

Semma Therapeutics

Semma Therapeutics

Quality Assurance
Boston, MA, USA
Posted on Tuesday, July 2, 2024

Job Description

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).

Key Duties and 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

Knowledge and Skills:

  • 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)

Education and Experience:

  • 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

We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Remote, Hybrid, or On-Site-Eligible role, you can choose to work:

1. On-Site and work 5 days per week with ad hoc flexibility;

2. Hybrid and work remotely up to two days per week; or select

3. Remote and work remotely with occasional travel to Vertex sites for business critical meetings/events.

#LI-AR1 #LI-Remote

Salary Range: $82,400- $123,600 USD annually

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. 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. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

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.

Pay Range:

$83,200 - $124,800

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. 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. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

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.

Flex Designation:

Remote-Eligible

Flex Eligibility Status:

In this Remote-Eligible role, you can choose to be designated as:
1. Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select
2. Hybrid: work remotely up to two days per week; or select
3. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

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