Senior Quality Assurance Executive
6 days ago
Job Title: Senior Quality Assurance Executive
Location: Waltham, MA or New York City
Estimated Salary:$200,000 - $250,000 per annum
About the RoleSyndax Pharmaceuticals is seeking an exceptional Senior Quality Assurance Executive to spearhead its commercial-stage quality organization. This role will be responsible for ensuring compliance with regulatory standards, driving quality initiatives, and supporting strategic goals.
The successful candidate will partner closely with internal and external stakeholders, including regulatory agencies, suppliers, and manufacturing partners, to ensure seamless and compliant launch and sustainment of Syndax's commercial product portfolio.
Duties and Responsibilities- Commercial QA Strategy: Develop and execute a robust quality assurance strategy tailored for commercial operations, aligning with Syndax's commercialization goals and global regulatory standards.
- Quality Systems Implementation and Optimization: Oversee the establishment, maintenance, and continuous improvement of commercial-stage quality systems. Drive continuous improvement initiatives and projects to improve processes and the QMS.
- Regulatory Compliance and Inspection Readiness: Serve as the quality lead in interactions with regulatory authority inspectorates (FDA, EMA, etc.) and other external auditors, ensuring audit readiness to support both planned and unplanned inspections.
- Cross-Functional Collaboration: Work closely with Manufacturing, Supply Chain, Regulatory Affairs, Clinical Operations, Pharmacovigilance, Medical Affairs, and other key teams to embed quality into each phase of the development and commercialization process.
- Product Quality Lifecycle Management: Implement robust quality management systems to support the entire product lifecycle from pre-clinical to maturity.
- Supplier and Partner Quality Management: Develop and oversee supplier qualification and audit programs to ensure third-party manufacturers, packagers, and distributors meet Syndax's quality standards.
- Risk Management and Issue Resolution: Lead risk assessments, implement mitigation strategies, and manage quality-related issues in the commercial supply chain to minimize risk to patients and business operations.
- Team Development and Leadership: Mentor and lead a high-performing QA team to foster a culture of quality across the organization.
- Education: Bachelor's degree in Life Sciences or a related field; advanced degree desirable but not required.
- Experience: Minimum 12 years' experience in the pharmaceutical or biotech industry in a quality or related role, with 5+ years in a commercial-stage role.
- Oncology Expertise: Experience in oncology or other high-impact therapeutic areas.
- GxP Knowledge: Demonstrated strong GxP knowledge and understanding of relevant global regulatory requirements.
- Leadership Abilities: Proven ability to lead and inspire a QA team, fostering a strong quality culture throughout an organization.
- Communication Skills: Excellent verbal and written communication skills, engaging and influencing internal and external stakeholders.
Lifelancer is a talent-hiring platform connecting professionals with opportunities in life sciences, pharma, health sciences, healthtech, and IT domains.
-
Senior Quality Assurance Specialist
3 days ago
Waltham, Massachusetts, United States Pyramid Consulting Full timeJob SummaryWe are seeking a skilled Senior Quality Assurance Specialist to join our team. This is a contract position located in Waltham, MA.Key Responsibilities:Review and approve Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated manufacturing documents for timely GMP manufacturing activities initiation.Perform QA...
-
Senior Software Quality Assurance Engineer
2 days ago
Waltham, Massachusetts, United States ZipRecruiter Full time**Job Title:** Senior Software Quality Assurance EngineerAbout the Role:We are seeking a highly skilled Senior Software Quality Assurance Engineer to join our team at Vicarious Surgical. As a Senior Software Quality Assurance Engineer, you will be responsible for developing and executing manual and automated test procedures for our surgical robot system.The...
-
Senior Quality Assurance Specialist
3 weeks ago
Waltham, Massachusetts, United States Pyramid Consulting, Inc Full timeAbout the RolePyramid Consulting, Inc. is currently seeking a Senior Quality Assurance Specialist to join our team in Waltham, MA. As a leading Healthcare Industry expert, we are looking for an experienced professional with 8+ years of relevant experience and minimum 5 years of experience in Quality.The ideal candidate will have a strong working knowledge...
-
Senior Quality Assurance Associate
3 weeks ago
Waltham, Massachusetts, United States Mindlance Full timeQuality Assurance Associate III**Job Summary**Mindlance is seeking a highly skilled Quality Assurance Associate III to join our team.**Key Responsibilities*** Review executed batch records and related documentation, resolve compliance issues, and dispose of lots of drug substance, bulk drug product, and clinical materials for use in clinical trials.* Perform...
-
Senior Quality Assurance Manager
3 weeks ago
Waltham, Massachusetts, United States RPM ReSearch Full timeJob DescriptionAt RPM ReSearch, we are seeking an experienced Senior Quality Assurance Manager to lead our quality team and ensure compliance with regulatory requirements.Key Responsibilities:Develop and implement effective quality management systems that meet or exceed regulatory standards.Supervise and guide internal audits of various departments and...
-
Senior Quality Assurance Specialist
2 weeks ago
Waltham, Massachusetts, United States Integrated Resources Full timeJob SummaryAs a Quality Assurance Associate III at Integrated Resources, you will be responsible for ensuring the quality and compliance of our products. This role is ideal for an individual with a strong background in quality assurance and a passion for ensuring the highest standards of quality.Key Responsibilities- Review and disposition lots of drug...
-
Waltham, Massachusetts, United States Lifelancer Full timeLead a Team in Ensuring Regulatory ComplianceWe are seeking an experienced Executive Director of Quality Assurance and Compliance to lead our quality team in ensuring regulatory compliance across all aspects of our operations.About the Role:Develop and implement a comprehensive quality strategy that aligns with our commercialization goals and global...
-
Senior Software Quality Assurance Engineer
5 days ago
Waltham, Massachusetts, United States Vicarious Surgical Full timeVicarious Surgical, a next-generation robotics company developing innovative surgical solutions, is seeking an experienced Senior Software Test Engineer to drive test development efforts for its cutting-edge surgical robot system.As a critical member of the Software Test Team, you will collaborate closely with the Integration team to develop and execute...
-
Quality Assurance Associate Lead
3 weeks ago
Waltham, Massachusetts, United States Mindlance Full timeJob Description:We are seeking a highly skilled Quality Assurance Associate II to join our team at Mindlance. In this role, you will be responsible for ensuring the highest quality standards in our manufacturing processes.Main Responsibilities:Review and approve Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated...
-
Quality Assurance Associate III
3 weeks ago
Waltham, Massachusetts, United States Pyramid Consulting, Inc Full timePosition OverviewPyramid Consulting, Inc. is a leading provider of consulting services to the Healthcare Industry. We are currently seeking a Quality Assurance Associate III to join our team in Waltham, MA.The ideal candidate will have a Bachelor's degree and 8+ years of relevant experience, with a minimum of 5 years of experience in Quality.This is a...
-
Quality Assurance Specialist
3 weeks ago
Waltham, Massachusetts, United States Goodwin Recruiting Full timeJob OverviewWe are seeking a seasoned Quality Assurance Specialist to lead our manufacturing operations. This role will be responsible for overseeing daily processes, ensuring smooth and efficient business activities.
-
Director of Quality Assurance
2 weeks ago
Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full timeOverviewDeciphera Pharmaceuticals, a member of ONO, is a biopharmaceutical company dedicated to developing innovative medicines for cancer treatment. With a focus on switch-control kinase inhibitors and a deep understanding of kinase biology, the company has established a robust pipeline of wholly-owned drug candidates.Salary$180,000 - $220,000 per year,...
-
Waltham, Massachusetts, United States Adobe Full timeJob Summary:Adobe is seeking a Quality Assurance and Test Engineering Specialist to join our team. As a key member of our product and infrastructure team, you will assist with the construction and testing of the Sign Application foundation using state-of-art cloud technologies, including AWS and Azure.Key Responsibilities:Support and develop...
-
Senior Software Quality Assurance Engineer
3 weeks ago
Waltham, Massachusetts, United States Vicarious Surgical Full timeJob OverviewWe are seeking an experienced Senior Software Test Engineer to join our growing team at Vicarious Surgical. This critical role will drive test development efforts for our novel surgical robot, working closely with the Integration team in an agile development environment.
-
Quality Assurance Manager
3 weeks ago
Waltham, Massachusetts, United States Pyramid Consulting, Inc Full timeJob DescriptionWe are seeking a Quality Assurance Manager to oversee quality-related activities at our client's facility in Waltham, MA. The ideal candidate will have a Bachelor's degree and 8+ years of relevant experience, with a minimum of 5 years of experience in Quality.This is a contract position with long-term potential and an estimated salary of...
-
Highly Experienced Quality Assurance Manager
3 weeks ago
Waltham, Massachusetts, United States Goodwin Recruiting Full timeJob SummaryWe are seeking an experienced Quality Assurance Manager to oversee daily operations in manufacturing, production, and logistics.This role will ensure smooth and efficient business processes, driving continuous improvement in quality, efficiency, and cost reduction.Responsibilities:Oversight of the full production cycle, including workforce,...
-
Senior Validation Specialist
3 weeks ago
Waltham, Massachusetts, United States Precision Life Sciences Full time**Job Overview**Precision Life Sciences is seeking a highly skilled Senior Validation Specialist to join our team.**Salary:** $95,000 - $115,000 per yearAs a Senior Validation Specialist at Precision Life Sciences, you will play a key role in ensuring the quality and compliance of our computer systems and equipment. We are looking for a motivated and...
-
Waltham, Massachusetts, United States Boston Children's Hospital Full timeOverviewBoston Children's Hospital is seeking a skilled Sterile Processing Quality Assurance Operations Specialist to join our team.
-
Waltham, Massachusetts, United States Boston Children's Hospital Full timeJob SummaryThe Boston Children's Hospital seeks a skilled Sterile Processing Quality Assurance and Instrumentation Specialist to join their team. This role is responsible for ensuring the accuracy and proper assembly of instrument trays according to pick sheets.The successful candidate will verify instrument placement, check for good working order, and...
-
Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full timeJob SummaryWe are seeking an experienced Associate Director to lead our GMP/GDP QA efforts for the development and commercialization of our products in compliance with US, EU, and ICH regulations.ResponsibilitiesEnsure proper QA oversight and collaboration with vendors for Drug Substance (DS) and Drug Product (DP).Review and approve Master Batch Production...