Quality Assurance Senior Specialist – Contract

Vertex Pharmaceuticals

. Support or execute quality activities and new/existing project initiatives .

Posted 11/2/2026contractBoston • Massachusetts • United StatesSenior💰 $65 - $70 per hourWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Assurance and Regulatory Compliance principles, with a strong focus on GMP regulations and quality oversight throughout the product lifecycle. Proven ability to lead investigations, perform root cause analysis, and implement corrective actions while collaborating effectively across cross-functional teams.

Highest-signal resume keywords

Quality AssuranceGMP RegulationsRoot Cause Analysis (RCA)CAPA ImplementationCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Systems ExecutionProduct DispositionChange Control AssessmentsGMP Document ReviewAnalytical TechniquesRisk-Based Decision MakingContinuous ImprovementEvent InvestigationsData ReviewQuality Agreements Drafting

Soft Skills

Good Written CommunicationGood Verbal CommunicationRelationship ManagementConflict ManagementProblem Solving

Industry Keywords

CGMPGxPPharmaceutical SciencesDrug DevelopmentClinical ProductsVendor ManagementInspection ReadinessAudit ManagementDeviation ManagementOOS and OOT Investigations

About the role

Key responsibilities & impact

Support or execute quality activities and new/existing project initiatives
Execute Quality systems supporting production and product advancement
Perform product disposition of clinical products, including drug substance, drug product intermediate, bulk drug product, and finished goods
Collaborate with Pharmaceutical Sciences, CMC Regulatory, GDP Finished Goods, Supply Chain, and R&D Quality
Work with CMC and Quality partners to optimize compliance and business requirements
Align with internal Quality functions, Vendor Management, Inspection Readiness, and Audit/Inspection Management
Support quality oversight for root-cause analysis and product impact assessments related to deviations, OOS, and OOT investigations
Ensure appropriate CAPA actions are identified
Support change control assessments, implementation, and closure
Identify and facilitate continuous improvement efforts
Support drafting and revising Quality Agreements between CMOs/Suppliers and Vertex
Represent Vertex Quality on cross-functional working teams
Perform review of executed batch documentation from external and/or internal manufacturing and testing, including executed batch records, release data, in-process controls, testing, and stability data
Support batch disposition for drug substance, drug product intermediate, drug product, and finished goods
Support GMP document review, including certificates of analysis

Requirements

What you’ll need

Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 3 years of relevant work experience, or equivalent combination of education and experience
Functional knowledge of quality assurance and regulatory compliance principles and applications
Working knowledge of early phase to commercial GMP drug substance and drug product manufacturing regulations
Prior Quality experience supporting multiple projects and teams involved in drug development activities
Experience supporting multiple projects/teams within stated objectives and timelines
Experience supporting cross-functional team members and collaborating effectively
Good written and verbal communication skills
Ability to integrate activities with other groups, departments, and project teams
Ability to support evaluation of quality matters and solve straightforward problems using technical experience and judgment based on precedent
Ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives
Expanded conceptual knowledge of cGMPs in a pharmaceutical setting
Proficiency in leading event investigations, Root Cause Analysis (RCA), and CAPA
Operational QA experience in an analytical or manufacturing setting, with experience in small molecules
Practical GxP knowledge across the product lifecycle
Knowledge of GMP regulations, Root Cause Analysis methodology and tools, analytical techniques, and data review
Ability to evaluate routine quality matters and make risk-based decisions
Relationship management and conflict management skills

Benefits

Comp & perks

Overtime pay eligibility in accordance with federal and state requirements
Compensation and medical benefits may be provided by the third-party agency partner upon offer
Other fringe benefits and employment terms presented by the third-party agency partner upon offer