

New · posted Nov 6
Vertex Pharmaceuticals · Biotechnology
GMP Operational Quality Senior Specialist
- Boston, MA
- Hybrid
- Full-time
- Senior & Principal
The role
The GMP Operational Quality Senior Specialist supports 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.
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 [email protected]
What you need
At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.
Knowledge and Skills
What you'll do
Pay and benefits
$94,200 – $141,200 a year
Employer provided$94,200 - $141,200
Medical, dental and vision benefits
Generous paid time off
Company shutdown in summer and winter
Educational assistance and student loan repayment
Commuting subsidy
401(k)
Where you'll work
Boston, MAHybridOpen in Maps (opens in a new tab)
More jobs in Boston, MAWorking conditions
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 Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

From the posting
About Vertex
Vertex is a global biotechnology company that invests in scientific innovation.
Equal opportunity, accessibility and legal noticesVertex Pharmaceuticals's statements, word for word
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.
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.
Job intelligence
The context around this role
Live data · November 6, 2026
Salary intelligence
How the pay compares
This role's midpoint is 23% above the US median for Quality Operations & Batch Release roles at this level.
This roleEmployer provided
Senior & Principal roles in the US16 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $94,200 | — | $141,200 |
| All US (middle half) | $91,875 | $95,500 | $105,875 |
This role: Vertex Pharmaceuticals's own published range. Comparisons: the base pay employers published on open Quality Operations & Batch Release roles at the same level on Regulatory Jobs, November 6, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Operations & Batch Release
The general path across 94 open Quality Operations & Batch Release roles on Regulatory Jobs, with the titles they carry most. Not Vertex's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 6 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance2
- Investigations and CAPA2
- Collaboration and leadership2
- Quality systems and risk1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Operations & Batch Release work in biotechnology, led by the three this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical ProductionNamed in the posting
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality AgreementsNamed in the posting
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- FDA21 CFR Parts 600 to 680(official source, opens in a new tab)FDA standards for biological products, from licensing to lot release
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- FDADrug Supply Chain Security Act(official source, opens in a new tab)Product tracing, verification and serialization across the US drug supply chain
- EUEU Good Distribution Practice(official source, opens in a new tab)Guidelines on good distribution practice of medicinal products for human use
- FDA21 CFR Part 7(official source, opens in a new tab)FDA enforcement policy, including product recalls
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
Company hiring pulse
Vertex on Regulatory Jobs
- 45
- Open roles
- 45
- Distinct roles
- 2
- Locations
By discipline
- Clinical21 47%
- Quality14 31%
- Regulatory10 22%
By level
- Director37 82%
- Manager5 11%
- VP & Executive1 2%
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GMP Operational Quality Senior Specialist at Vertex
Open until filled. $94K–$141K a year, employer provided.


