Top 2304 Documentation manager Jobs in Boston Ma

Senior Manager, Clinical Study Quality Lead (Hybrid)
Vertex Pharmaceuticals —Boston, MA
- $137,800 - $206,800 a year
- Full-time
- Hybrid work
- 6 years
- Project management
- Bachelor's degree
- Loan repayment program
- Dental insurance
Senior Manager, Regulatory Lead
Takeda Pharmaceutical —Boston, MA
- $137,000 - $215,270 a year
- Full-time
- Bachelor of Science
- Office
- Bachelor's degree
- Paid holidays
- Disability insurance
Senior Manager, RDQ Learning & Documentation Governance
Vertex Pharmaceuticals —Boston, MA
- $129,400 - $194,200 a year
- Full-time
- 5 years
- Senior level
- Communication skills
- Loan repayment program
- Dental insurance
8d
Medical Writing Manager (Hybrid)
Vertex Pharmaceuticals —Boston, MA
- $120,200 - $180,400 a year
- Full-time
- Hybrid work
- Word processing
- Analysis skills
- Doctor of Philosophy
- Loan repayment program
- Dental insurance
QA Manager- Finished Goods Commercial
Vertex Pharmaceuticals —Boston, MA
- $118,400 - $177,600 a year
- Full-time
- Hybrid work
- Bachelor's degree
- Product management
- Conflict management
- Loan repayment program
- Dental insurance
Curriculum Manager
The Possible Zone —Boston, MA
- $85,000 - $110,000 a year
- Full-time
- Spanish
- High school
- Mid-level
- Paid parental leave
- Paid holidays
Documentation & Inspection Readiness Manager
Kiniksa Pharmaceuticals —Lexington, MA
- $140,000 - $148,000 a year
- Full-time
- Bachelor's degree
- Organizational skills
- SharePoint
Quick Apply
Documentation Manager
QUANTUM COMPUTING, INC. —Bedford, MA
- $119,000 - $150,000 a year
- 5 years
- ERP systems
- Supervising experience
Quick Apply
1d
Medical Records and Health Information Manager
Backpack Healthcare —Boston, MA
- $75,000 - $80,000 a year
- Full-time
- Remote
- Mid-level
- Children
- Pediatrics
Quick Apply
Program Manager, Arts & Creativity
The Boston Foundation —Boston, MA
- $75,000 - $90,000 a year
- Full-time
- Hybrid work
- Microsoft Excel
- Mid-level
- Office
Senior Manager, Ontology
Takeda Pharmaceutical —Boston, MA
- $137,000 - $215,270 a year
- Full-time
- Bachelor's degree
- Doctor of Philosophy
- Senior level
- Paid holidays
- Disability insurance
4d
Training and Technology Adoption Manager (hybrid)
MERCHANT & GOULD PC —Boston, MA
- $85,000 - $135,000 a year
- Full-time
- Mid-level
- Windows
- Travel
- AD&D insurance
- Disability insurance
Quick Apply
Population Health Manager
Codman Square Health Center Inc —Boston, MA
- $81,120.00 - $126,380.80 a year
- Nursing
- Mid-level
- 3 years
Quick Apply
Assessment Manager (Anticipated Vacancy) (SY26-27)
Boston Public Schools —Boston, MA
- Up to $108,859 a year
- Full-time
- School experience
- Spanish
- Customer service
Project Manager
Northeastern University —Boston, MA
- $40 - $70 an hour
- Part-time
- Remote
- Mid-level
- 3 years
- Bachelor's degree
- Health insurance
- Dental insurance
6d
AV Support Manager
Harvard University —Boston, MA
- Full-time
- Hybrid work
- Classroom
- Office
- Supervising experience
- Commuter assistance
- Health insurance
Program Manager, Research
Beth Israel Lahey Health —Boston, MA
- $65,000.00 - $119,995.20 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Hospital
7d
Manager, Procurement Operations
Amylyx Pharmaceuticals —Cambridge, MA
- $125,000 - $141,000 a year
- Mid-level
- 3 years
- Bachelor's degree
14d
Procurement Manager - Contracts Administrator
Athenahealth —Boston, MA
- $89,000 - $151,000 a year
- Full-time
- Oracle
- Finance
- 8 years
- Commuter assistance
- Tuition reimbursement
Document Controls Manager
WSP —Boston, MA
- $140,000 - $155,000 a year
- 7 years
- Microsoft Excel
- Supervising experience
- Paid parental leave
- Disability insurance

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Senior Manager, Clinical Study Quality Lead (Hybrid)

Vertex Pharmaceuticals -
Boston, MA

Apply Now

Job Details

Full-time
$137,800 - $206,800 a year

Benefits

Loan repayment program
Dental insurance
Tuition reimbursement
Paid time off
Vision insurance
401(k) matching

Qualifications

Quality control corrective actions
Risk management compliance audits
Investigations regulatory compliance
Defect resolution root cause analysis
Clinical trial risk management
Clinical research audit management
Preventive action implementation
Corrective and preventive actions (CAPA)
Internal investigations
Quality control audit
Clinical audit and monitoring
ICH guidelines
Project management
Regulatory readiness in healthcare
Audit risk assessments
Research regulatory compliance
Clinical quality assurance standards
Root cause analysis
Clinical program risk management
Cross-functional communication

Full Job Description

Job Description

General Summary:

The Senior Manager, Clinical Study Quality Lead provides study-level quality oversight for assigned clinical trials to help ensure they are conducted in compliance with Good Clinical Practice (GCP), applicable global regulations, study protocols, and Vertex procedures. This is an individual contributor role focused on GCP quality assurance oversight for clinical trials, including risk-based audit strategy, quality risk identification, issue escalation, CAPA support, compliance trend analysis, and inspection readiness. The role partners closely with clinical study teams and external stakeholders, including CROs, vendors, and investigator sites, to support quality outcomes across Vertex clinical programs. The ideal candidate brings direct, hands-on GCP QA experience supporting clinical trials in a sponsor, CRO, or similarly regulated clinical research environment. This position is on-site or hybrid and is not eligible for a fully remote work arrangement.

Key Duties and Responsibilities:

Serve as the Clinical Study Quality Lead for assigned trials, providing GCP QA oversight and guidance to clinical study teams and key stakeholders.
Partner cross-functionally with clinical study teams, CROs, vendors, and investigator sites to support quality oversight and maintain inspection readiness.
Conduct risk-based quality reviews of protocols, informed consent documents, and other key study documentation to identify potential compliance and operational risks.
Advise clinical study teams on quality risks and support the development of practical, risk-based mitigation strategies.
Develop and oversee investigator site audit plans for assigned studies, ensuring alignment with study risk, audit strategy, and company expectations.
Lead and/or support domestic and international investigator site audits and inspection readiness activities.
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 analysis, CAPA planning, and follow-up of effectiveness measures.
Review and monitor clinical quality data, compliance signals, and study-level trends, escalating significant risks or concerns as appropriate.
Contribute to ongoing process improvement and continuous quality initiatives to strengthen GCP compliance across clinical programs.
Support regulatory agency inspections at Vertex and/or clinical investigator sites, as needed.
May contribute to the review of SOPs, work instructions, and internal guidance documents that support the clinical quality management system.

Required Experience:

Bachelor’s degree and 6+ years of direct GCP Quality Assurance experience providing oversight for clinical trials, or the equivalent combination of education and experience.
Candidates must have direct, hands-on experience providing GCP QA oversight for clinical trials.
Experience supporting clinical study quality in a sponsor, CRO, or similarly regulated clinical research environment.
Experience supporting clinical development programs for drugs and biologics.

Required Knowledge/Skills:

Strong knowledge of ICH GCP E6(R3) and applicable global clinical trial regulations and guidance.
Demonstrated experience in GCP clinical trial quality oversight, including audit support, inspection readiness, quality issue management, root cause analysis, and CAPA.
Ability to identify GCP compliance risks, assess impact, and apply risk-based quality principles in a clinical trial environment.
Strong communication skills, with the ability to work effectively across internal and external stakeholders.
Ability to work independently, manage multiple priorities, and deliver high-quality work in a fast-paced environment.
Strong organizational, project management, and problem-solving skills.

Preferred Skills:

Experience supporting devices, combination products, or cell and gene therapy clinical trials.
Experience supporting GCP QA activities in a Phase 1 Clinical Research Unit is highly desirable.
Professional certification such as RQAP-GCP, CCRP, or similar.

Other Requirements:

Up to 10% travel may be required.

Pay Range:

$137,800 - $206,800

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 [email protected]

Apply Now

Refine Your Search

documentation manager jobs in boston ma

Senior Manager, Clinical Study Quality Lead (Hybrid)

Senior Manager, Regulatory Lead

Senior Manager, RDQ Learning & Documentation Governance

Medical Writing Manager (Hybrid)

QA Manager- Finished Goods Commercial

Curriculum Manager

Documentation & Inspection Readiness Manager

Documentation Manager

Medical Records and Health Information Manager

Program Manager, Arts & Creativity

Senior Manager, Ontology

Training and Technology Adoption Manager (hybrid)

Population Health Manager

Assessment Manager (Anticipated Vacancy) (SY26-27)

Project Manager

AV Support Manager

Program Manager, Research

Manager, Procurement Operations

Procurement Manager - Contracts Administrator

Document Controls Manager

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