Seaport Therapeutics is seeking an experienced Director, Clinical Quality Assurance to manage clinical quality activities supporting clinical development programs, ensuring compliance with regulatory ...
Seaport Therapeutics is seeking an experienced Director, Clinical Quality Assurance to manage clinical quality activities supporting clinical development programs, ensuring compliance with regulatory ...
Specialist, Quality Assurance
Boston, MA · On-site
With programs like Future of Medicine , which makes advanced health screenings and research ... Issue Resolution & CAPA Management: Partner directly with research staff and Principal ...
Specialist, Quality Assurance
Boston, MA · On-site
With programs like Future of Medicine , which makes advanced health screenings and research ... Issue Resolution & CAPA Management: Partner directly with research staff and Principal ...
QA Analyst
Waltham, MA · On-site
... of program logic and system flow. • Manages and participates in the analysis and design phases of QA projects by collaborating with off shore team to create test scenario and acceptance test ...
QA Analyst
Waltham, MA · On-site
... of program logic and system flow. • Manages and participates in the analysis and design phases of QA projects by collaborating with off shore team to create test scenario and acceptance test ...
Sr. Manager, Quality Assurance
Boston, MA · On-site
Position Overview The Sr Quality Assurance Manager will lead a global team of Automation Engineers and QA SMEs in product testing with the .NET tech stack at ZELIS. This is a hands-on leadership role ...
Sr. Manager, Quality Assurance
Boston, MA · On-site
Position Overview The Sr Quality Assurance Manager will lead a global team of Automation Engineers and QA SMEs in product testing with the .NET tech stack at ZELIS. This is a hands-on leadership role ...
... and communicated to senior management. This position is located in Cambridge, MA. Key ... Participate in the company internal compliance audit program. * Participate in the development of ...
... and communicated to senior management. This position is located in Cambridge, MA. Key ... Participate in the company internal compliance audit program. * Participate in the development of ...
... and communicated to senior management. This position is located in Cambridge, MA. Key ... Participate in the company internal compliance audit program. * Participate in the development of ...
... and communicated to senior management. This position is located in Cambridge, MA. Key ... Participate in the company internal compliance audit program. * Participate in the development of ...
Quality Assurance Analyst
Boston, MA · On-site
... Supplier Quality Management (SQM), auditing, and PMA. * Support quality-related projects and ... Strong skills in data compilation, analysis, and program tracking * Proficiency with Microsoft Word ...
Quality Assurance Analyst
Boston, MA · On-site
... Supplier Quality Management (SQM), auditing, and PMA. * Support quality-related projects and ... Strong skills in data compilation, analysis, and program tracking * Proficiency with Microsoft Word ...
Quality Assurance Analyst
Boston, MA · On-site
... Supplier Quality Management (SQM), auditing, and PMA. * Support quality-related projects and ... Strong skills in data compilation, analysis, and program tracking * Proficiency with Microsoft Word ...
Quality Assurance Analyst
Boston, MA · On-site
... Supplier Quality Management (SQM), auditing, and PMA. * Support quality-related projects and ... Strong skills in data compilation, analysis, and program tracking * Proficiency with Microsoft Word ...
QA Analyst
Waltham, MA · On-site
... Vendor Management Programs. Collabera recognizes true potential of human capital and provides ... Title: QA Lead Location: Waltham, MA Duration: 6 month (may extend) Our top direct client is ...
QA Analyst
Waltham, MA · On-site
... Vendor Management Programs. Collabera recognizes true potential of human capital and provides ... Title: QA Lead Location: Waltham, MA Duration: 6 month (may extend) Our top direct client is ...
QA Analyst
Boston, MA · On-site +1
Identify, document, and track defects using test management tools * Collaborate with developers, business analysts, and stakeholders to resolve issues * Lead QA activities and support or guide junior ...
QA Analyst
Boston, MA · On-site +1
Identify, document, and track defects using test management tools * Collaborate with developers, business analysts, and stakeholders to resolve issues * Lead QA activities and support or guide junior ...
Manager, Quality Assurance
Bedford, MA · On-site
$127K - $158K/yr
You will experience these qualities of passion, pride and aspiration in many ways - from a rich set of career development programs to support of community service projects to social events that ...
Manager, Quality Assurance
Bedford, MA · On-site
$127K - $158K/yr
You will experience these qualities of passion, pride and aspiration in many ways - from a rich set of career development programs to support of community service projects to social events that ...
About the job Mailroom Quality Assurance Associate Mailroom Quality Assurance Associate needs 1+ ... Maintains Quality Management System (QMS) programs and initiatives. • Provides critical ...
About the job Mailroom Quality Assurance Associate Mailroom Quality Assurance Associate needs 1+ ... Maintains Quality Management System (QMS) programs and initiatives. • Provides critical ...
Senior Manager, QA Operations
Waltham, MA · On-site
$160K - $180K/yr
The Manager is a hands-on manager that provide quality support of manufacturing, Quality Control ... Support training program for QA operations specialists which include training curricula, raw ...
Senior Manager, QA Operations
Waltham, MA · On-site
$160K - $180K/yr
The Manager is a hands-on manager that provide quality support of manufacturing, Quality Control ... Support training program for QA operations specialists which include training curricula, raw ...
Quality Assurance Analyst
Quincy, MA · On-site
The QA Analyst will collaborate with developers, business analysts, and the QA manager to validate system functionality, safeguard data integrity, track issues, and drive continuous improvement ...
Quality Assurance Analyst
Quincy, MA · On-site
The QA Analyst will collaborate with developers, business analysts, and the QA manager to validate system functionality, safeguard data integrity, track issues, and drive continuous improvement ...
Senior Manager, QA Operations
Waltham, MA · On-site
The Manager is a hands-on manager that provide quality support of manufacturing, Quality Control ... Support training program for QA operations specialists which include training curricula, raw ...
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Senior Manager, QA Operations
Waltham, MA · On-site
The Manager is a hands-on manager that provide quality support of manufacturing, Quality Control ... Support training program for QA operations specialists which include training curricula, raw ...
The Manager is a hands-on manager that provide quality support of manufacturing, Quality Control ... Support training program for QA operations specialists which include training curricula, raw ...
The Manager is a hands-on manager that provide quality support of manufacturing, Quality Control ... Support training program for QA operations specialists which include training curricula, raw ...
Principal Clinical Quality Assurance Specialist
Marlborough, MA · Hybrid
$37.75 - $50.50/hr
As a Principal Clinical Quality Assurance Specialist, you will support the internal clinical quality assurance program for your assigned business area, partnering with cross-functional teams to ...
Principal Clinical Quality Assurance Specialist
Marlborough, MA · Hybrid
$37.75 - $50.50/hr
As a Principal Clinical Quality Assurance Specialist, you will support the internal clinical quality assurance program for your assigned business area, partnering with cross-functional teams to ...
Principal Clinical Quality Assurance Specialist
Marlborough, MA · Hybrid
$37.75 - $50.50/hr
As a Principal Clinical Quality Assurance Specialist, you will support the internal clinical quality assurance program for your assigned business area, partnering with cross-functional teams to ...
Principal Clinical Quality Assurance Specialist
Marlborough, MA · Hybrid
$37.75 - $50.50/hr
As a Principal Clinical Quality Assurance Specialist, you will support the internal clinical quality assurance program for your assigned business area, partnering with cross-functional teams to ...
Principal Clinical Quality Assurance Specialist
Marlborough, MA · On-site
$37.75 - $50.50/hr
As a Principal Clinical Quality Assurance Specialist, you will support the internal clinical quality assurance program for your assigned business area, partnering with cross-functional teams to ...
Principal Clinical Quality Assurance Specialist
Marlborough, MA · On-site
$37.75 - $50.50/hr
As a Principal Clinical Quality Assurance Specialist, you will support the internal clinical quality assurance program for your assigned business area, partnering with cross-functional teams to ...
* Experienced in implementing Agile scrum methodology developing and leading software QA programs and teams developing test metrics, test strategy, test plans, built test beds and automation ...
* Experienced in implementing Agile scrum methodology developing and leading software QA programs and teams developing test metrics, test strategy, test plans, built test beds and automation ...
Quality Assurance Program Manager information
See Dedham, MA salary details
$39K - $52.2K
3% of jobs
$52.2K - $65.4K
6% of jobs
$65.4K - $78.5K
11% of jobs
$84.2K is the 25th percentile. Wages below this are outliers.
$78.5K - $91.7K
12% of jobs
$91.7K - $104.9K
11% of jobs
The median wage is $117.2K / yr.
$104.9K - $118K
8% of jobs
$118K - $131.2K
4% of jobs
$141K is the 75th percentile. Wages above this are outliers.
$131.2K - $144.4K
27% of jobs
$144.4K - $157.5K
1% of jobs
$157.5K - $170.7K
1% of jobs
$170.7K - $183.9K
16% of jobs
$39K
$121.3K
$183.9K
How much do quality assurance program manager jobs pay per year?
What does a quality assurance program manager do?
What are the key skills and qualifications needed to thrive as a quality assurance program manager?
How does a quality assurance program manager typically collaborate with cross-functional teams to ensure product quality?
What is the difference between Quality Assurance Program Manager vs Quality Control Supervisor?
| Aspect | Quality Assurance Program Manager | Quality Control Supervisor |
|---|---|---|
| Certifications | ASQ CQE, Six Sigma, PMP | ISO 9001, Six Sigma, CQE (optional) |
| Work Environment | Oversees quality systems across departments, strategic planning | Supervises daily inspection and testing activities |
| Employer & Industry Usage | Manufacturing, aerospace, healthcare, software | Manufacturing, production, industrial settings |
The Quality Assurance Program Manager focuses on developing and maintaining quality systems and processes, ensuring compliance and continuous improvement. In contrast, the Quality Control Supervisor manages daily inspection and testing to ensure products meet quality standards. Both roles are essential in quality management but differ in scope and responsibilities.
Is a quality assurance program manager a stressful job?
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Full-time
Re-posted 17 days ago
Job description
Seaport Therapeutics is seeking an experienced Director, Clinical Quality Assurance to manage clinical quality activities supporting clinical development programs, ensuring compliance with regulatory requirements and company policies. This role reports to the VP of Quality.
The Director, Clinical Quality Assurance leads GCP compliance and quality oversight for clinical programs. This role is responsible for developing and implementing risk-based strategies; managing audits, inspection readiness, and vendor oversight; and ensuring global regulatory compliance. This role partners cross-functionally to drive continuous improvement, inspection readiness, and sponsor oversight, while proactively identifying and mitigating quality risks. As a subject matter expert, this role establishes program support to uphold industry best practices and regulatory requirements.
The ideal candidate will embrace a collaborative, innovative culture that embodies our values of service to patients impacted by mental health conditions, with a "we own it" mentality, demonstrating entrepreneurial spirit and technical excellence while fostering teamwork and continuous improvement. This position is based in Boston's Seaport area, with a strong preference for being onsite 4 days per week.
Summary of Key Responsibilities
- Inform and contribute to audit planning and strategy
- Perform and/or coordinate clinical site and vendor audits
- Oversee deviations, quality issues (QIs), CAPAs, effectiveness checks, root cause analyses, and associated KPIs
- Advise internal stakeholders and external partners on GCP compliance matters and identify emerging non-compliance trends
- Support inspection readiness activities and co-host regulatory inspections
- Develop and deliver GCP-related training; contribute to the creation, revision, and maintenance of policies, SOPs, and work instructions in alignment with global regulatory requirements
- Conduct and/or manage the qualification and oversight of service providers
- Ensure service providers adhere to quality programs and applicable regulations, maintaining inspection readiness
- Assess and escalate compliance risks identified through audits to protect subject safety, data integrity, and business continuity
- Lead or support the preparation for and response to regulatory audits and inspections, ensuring adherence to requirements and timely resolution of findings
- Support investigational new drug (IND) applications and related correspondence with global regulatory authorities
- Other duties as assigned
Qualifications
- Bachelor's degree with 12+ years of related experience preferably in life sciences with 8+ years of experience in a Clinical Quality Assurance role, or an equivalent combination of PV and QA experience
- Deep knowledge of global regulations (e.g., FDA, EMA) and guidelines (e.g., ICH, GVP, GxP), including safety reporting requirements
- Broad clinical development experience across all phases (Phase I through BLA/NDA)
- Strong understanding of GCP quality principles spanning preclinical, clinical, and commercial stages
- Proven experience developing and implementing risk-based clinical quality assurance programs
- Demonstrated success leading clinical site and supplier audits, managing regulatory inspections, and responding to findings
- Skilled at effectively communicating quality events and outcomes to internal stakeholders
- Excellent interpersonal, verbal, and written communication skills (must have)
- Working knowledge of multiple therapeutic areas is a plus
- Results-oriented, with the ability to set clear objectives, manage competing priorities, and meet dynamic timelines
- Flexible and creative problem solver with a proactive mindset
- Highly collaborative team player who fosters open communication and cross-functional cooperation
- Willingness to travel up to 20% based on business needs
At Seaport, we believe transparency and fairness are key to building a culture of trust, respect, and collaboration. We care deeply about the happiness of our team and strive to ensure our total rewards (monetary and non-monetary) program reflects the value each person brings. The expected salary range for this role is $198,000-$225,000, with the final offer based on experience, market data, and internal equity. We encourage open conversations with our talent acquisition team about compensation early in the process to ensure alignment from the start.