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GMP Operational Quality Senior Specialist (Stability)

Vertex Pharmaceuticals

Job Location:

Boston, MA - USA

Monthly Salary: $ 94200 - 141200

Posted: 19 July 2026 (30+ days ago)

Application Deadline: 16 October 2026

Vacancies: 1 Vacancy

Job Summary

Job Description

General Summary:

The GMP Operational Quality Senior Specialist is recognized as a subject matter expert in the principles and application of quality assurance and regulatory compliance. The incumbent supports or executes a wide range of straightforward activities and supports new/existing project initiatives. The role works with a high degree of independence and coordinates GMP activities to provide QA Analytical support for commercial product stability programs and executes routine tasks and activities in support of QA Analytical function.

Key Duties and Responsibilities:

Provides QA review of the GMP data in support of commercial product stability as required.

Has a good understanding of stability requirements per ICH and experience in stability protocol management.

Collaborate with internal and external business partners to resolve quality issues to ensure compliant solutions in support of QA Analytical function.

Represents QA Analytical on cross-functional teams as an experienced Quality technical resource as needed.

Supports quality oversight of Root Cause Analysis (RCA) and product impact assessment for deviation and OOS/OOT investigations. Ensure that appropriate CAPA actions are identified. May approve investigations/CAPAs.

Manages stability impacting change control activities such as assessment implementation and closure.

Conducts GMP document review including procedures work instructions specifications methods protocols and reports.

Supports external stability program activities for commercial products such as internal/external protocol review/approval data review/approval and study initiation.

Enforces Quality Agreements between CMOs/Suppliers and Vertex as applicable to stability study pulls test initiation data reporting and OOS/OOT management.

Identifies and facilitates continuous improvement efforts.

Identifies and communicates risks and assists with risk mitigation plans where applicable.

Knowledge and Skills:

Knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting including knowledge of global GMP requirements in regard to GMP manufacturing and testing.

Knowledge of basic analytical techniques in a Quality/commercial setting (e.g. HPLC dissolution GC KF etc.)

Experience in supporting Quality Event Investigations RCA and CAPA implementation.

Experience in assessing and managing Change Controls

Experience working with Contract Manufacturing Organizations (CMOs)/Contract Testing Organization (CTOs).

Experience supporting multiple projects/teams ability to work in a fast-paced environment and meet quality accuracy and timelines.

Demonstrated ability to evaluate quality matters and make decisions leveraging technical experience and judgement.

Good communication skills (written and verbal) and the ability to communicate cross-functionally to a variety of audiences.

Demonstrated ability to work independently to provide QA advice for large multifaceted projects

Experience in supporting Quality Event Investigations RCA and CAPA implementation.

Experience in assessing Change Controls

Experience with electronic document management systems (e.g. LIMS Veeva).

Education and Experience:

Bachelors degree in a scientific discipline (or equivalent degree) and 3-4 years of experience or the equivalent combination of education and experience.

Advance knowledge of GMP regulations and applicability.

Operational QA experience in analytical or manufacturing setting interpretation and application of GMPs and applicable guidelines/guidances ex. ICH USP etc.

Experience in Root Cause Analysis tools/methodology and technical writing.

Facilitation/problem solving/organizational planning skills in a regulated environment.

Pay Range:

$94200 - $141200

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:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

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

#LI-Hybrid

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 persons 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