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Capa Jobs in Boston, MA (NOW HIRING)

Vrtx

Senior Manager, Clinical Study Quality Lead

Boston, MA · Hybrid

$137K - $206K/yr

Review audit reports, responses, and CAPA plans to ensure findings are appropriately assessed, addressed, and resolved in a timely manner. * Support quality issue investigations, including root cause ...

New

Deloitte

System Test and Validation Lead

Boston, MA · On-site +1

Lead CAPA activities for validation findings, including root cause analysis, effectiveness checks, closure documentation, and tracking of open compliance actions * Validate AI/ML-enabled GxP systems ...

Beacon Engineering Resources

Quality Engineer

Boston, MA

$78K - $101K/yr

Lead and support Root Cause Analysis and Corrective and Preventive Action (CAPA) activities. * Participate in Non-Conforming Material Review Boards (MRB) and support disposition of nonconforming ...

Integrated Resources INC

Quality Engineer

Mansfield, MA

$76K - $98K/yr

Initiate, drive, or support CAPA related to product performance, compliance, or continuous improvement. Maintain knowledge base on new regulations and standards that affect Risk Management for ...

Foundation Medicine

Senior Quality Engineer

Boston, MA · On-site

$101K - $126K/yr

The position supports Quality Systems processes including CAPA, nonconformance, change control, document control, training, audit management, risk management, and Management Review. Regular onsite ...

Axcelis

Customer Quality Engineer II

Beverly, MA

$79K - $102K/yr

Track and analyze quality KPIs (defects, response time, field failures, CAPA effectiveness) * Develop dashboards and reports for internal reviews and customer communication Continuous Improvement

Ametek

Quality Manager

Chelmsford, MA

Provide training, guidance, and support to ensure effective root cause analysis and corrective action (CAPA) processes across the organization. * Ensure company compliance with applicable global ...

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Capa information

What are the typical daily responsibilities of a CAPA specialist?

A CAPA specialist is responsible for investigating quality issues, identifying root causes, and implementing corrective and preventive actions to ensure ongoing compliance and product integrity. Their typical day involves reviewing nonconformance reports, collaborating with cross-functional teams, documenting findings, and tracking the progress of CAPA initiatives using specialized software. CAPA specialists also prepare reports for audits and may facilitate meetings to drive continuous improvement activities. This role often requires balancing multiple projects and deadlines in a regulated environment, making organizational and communication skills crucial for success.

What are the key skills and qualifications needed to thrive in the CAPA position, and why are they important?

To thrive as a CAPA (Corrective and Preventive Action) specialist, you need expertise in quality management systems, root cause analysis, and compliance with industry standards, typically backed by a degree in engineering, life sciences, or a related field. Familiarity with CAPA software, regulatory frameworks (such as ISO 13485 or FDA 21 CFR Part 820), and document control systems is essential. Strong analytical thinking, attention to detail, and effective communication skills are vital soft skills for this role. These skills ensure effective problem-solving and sustained compliance, which are essential for maintaining product quality and meeting regulatory requirements.

What is a CAPA?

A CAPA (Corrective and Preventive Action) job involves identifying, investigating, and resolving quality issues in industries like manufacturing, healthcare, and pharmaceuticals. CAPA professionals analyze root causes of defects or process failures and implement corrective actions to prevent recurrence. They ensure compliance with regulatory standards, document findings, and improve overall quality management systems. Their role is critical in maintaining product safety, efficiency, and regulatory adherence.

What are popular job titles related to Capa jobs in Boston, MA? For Capa jobs in Boston, MA, the most frequently searched job titles are:
What job categories do people searching Capa jobs in Boston, MA look for? The top searched job categories for Capa jobs in Boston, MA are:
Capa jobs near you
Infographic showing various Capa job openings in Boston, MA as of August 2026, with employment types broken down into 86% Full Time, 4% Part Time, 1% Temporary, 8% Contract, and 1% Nights. Highlights an 95% Physical, 2% Hybrid, and 3% Remote job distribution.

Clinical Study Quality Lead, Associate Director

Vertex Pharmaceuticals

Boston, MA • On-site

$39.75 - $53/hr

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 24 days ago

Vertex Pharmaceuticals rating

6.5

Company rating: 6.5 out of 10

Based on 5 frontline employees who took The Breakroom Quiz

78th of 86 rated pharmaceutical

Job description

Job Description
General Summary:
The Clinical Study Quality Lead (SQL), Associate Director is responsible for advanced quality assurance oversight of clinical trial operations and applicable vendors, across a range of study phases within assigned disease area(s). The SQL will ensure clinical trials are conducted in accordance with GCP requirements, applicable protocols, Vertex policies and procedures and quality standards as set forth in the Quality Management System. Overall, the SQL is responsible for the development and execution of audit/quality plans, accurately identifying and communicating compliance risks and overseeing action plans to mitigate risks, real-time study inspection readiness oversight, and collaboratively identifying and driving inspection preparedness strategies and activities.
This position may evolve to include line management responsibilities.
Key Duties and Responsibilities:
  • Serves as key technical resource and GCP subject matter expert, to clinical study execution functions.
  • Provides strategic, risk-based GCP quality compliance oversight of studies within assigned disease areas to drive compliance with regulatory requirements to ensure the protection of participants' safety, rights, and well-being as well as the integrity and credibility of study data generated.
  • Provides consultation, interpretation and information on regulations, standards, and quality systems to clinical study execution functions
  • Partners with clinical and other study functional teams to engage proactive quality management approaches in support of risk mitigation and quality outcomes
  • Proactively supports and/or identifies study/program quality risks ensuring that risks are communicated and mitigated in a timely manner.
  • Participates in risk management forums with responsibility for assessing GCP compliance risk areas; Develops and implements quality risk management plans and measures.
  • Partners with operational teams to develop risk-based quality and/or audit plans for assigned programs, ensuring audits are conducted in accordance with the plan. Reviews audit reports and may evaluate responses and CAPA plans.
  • Develops and executes inspection preparedness strategy for assigned studies/programs in collaboration with Functional Area and Quality partners. Participates in inspection activities from preparation to response execution.
  • Conducts directed or for cause audits and site inspection preparation visits as needed
  • Oversees investigation and approves quality event investigations and CAPA(s)
  • May provide regular updates on study and program status to the R&D Quality Leadership Team and senior stakeholders in GCP Quality. May provide direction and expertise at management review meetings on GCP-related activities/risks/issues.
  • Represents Quality in study management and quality/compliance forums, teams, governance, etc. as well as on interdepartmental process improvement and business initiatives involving GCP systems, processes, procedures, regulations, and tools.
  • May provide subject matter expertise and participate in the development and review of procedural documents related to the Quality Management System (e.g., CAPA, Quality Issue Management, regulatory inspections, quality risk management).
  • Maintains an in-depth understanding of business principles, current industry trends, standards, and methodologies and regulatory environment as relates to clinical development, quality management and Good Clinical Practice.
  • Participates in the evaluation and selection of GCP service providers
  • Monitors key quality indicators and departmental metrics for and identifies opportunities to optimize processes and procedures (SOPs, Work Instructions).
  • May act on behalf of overseeing Clinical Quality Program Lead
  • Mentor and train junior SQLs, as needed
  • Role may progress to include people management responsibilities including hiring, oversight of day-to-day execution, employee goal setting, performance management, and career development activities

Education and Experience:
  • Bachelor's degree in a scientific or allied health field (or equivalent degree) and 8+ years of relevant work experience, or relevant comparable background

Required Experience:
  • In depth knowledge and awareness of ICH-GCP guidelines and applicable global regulations and guidance for clinical development (e.g., FDA, EMA, MHRA, etc.)
  • Experience across phases of clinical trial development involving drugs, and biologics
  • In depth understanding of Event Management processes and requirements, including investigation, root cause analysis, CAPA plan development and Effectiveness Checks
  • Ability to understand and translate business partner needs for innovation and creative, risk-based approaches to quality management
  • Communicates professionally, clearly, and concisely both verbally and in writing to internal and external customers
  • Excellent organizational skills, problem solving and conflict resolution skills
  • Must be able to organize and prioritize work effectively to meet timelines with quality deliverables
  • Must possess the necessary scientific education and knowledge to manage quality oversight for clinical trials, understand medical terminology, standards of care and disease states to assure the ethical treatment of participants
  • Must be able to work independently and in a collaborative team setting
  • Proficient in using Microsoft Office applications (MS Word, MS Excel, MS PowerPoint, Smartsheet, Visio)
  • Strong experience with key performance indicators, metrics analysis, and monitoring/trending of quality and compliance metrics

Other Requirements
  • Prior experience with medical device manufacture and transition to clinical studies or Cell and Gene Therapy is advantageous.
  • Professional clinical trial certification (e.g., CCRP, RQAP-GCP, etc.) is preferred
  • Travel up to 10% is required to Vertex sites, vendors, investigator sites, etc.

#LI-Hybrid
Pay Range:
$160,600 - $240,800
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:
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.
#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 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

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