Director of Quality Control

1 day ago


Waltham, Massachusetts, United States Lifelancer Full time
Role Overview

We are seeking a Director of Quality Control to lead our Quality organization in ensuring compliance with regulatory standards and driving quality initiatives.

About the Role

The ideal candidate will have a strong background in GxP quality systems, risk management, and continuous improvement. They will be responsible for developing and executing a robust quality assurance strategy, overseeing the establishment and maintenance of commercial-stage quality systems, and collaborating with cross-functional teams to ensure quality and compliance standards.

Responsibilities
  • Develop and execute a commercial QA strategy aligned with global regulatory standards
  • Oversee the implementation and optimization of commercial-stage quality systems
  • Ensure regulatory compliance and inspection readiness
  • Collaborate with manufacturing, supply chain, regulatory affairs, and other key teams to embed quality into development and commercialization processes
  • Manage supplier and partner quality programs to ensure consistent quality standards
  • Lead risk assessments and implement mitigation strategies to minimize risk to patients and business operations
Requirements
  • Bachelor's degree in Life Sciences or related field; advanced degree desirable but not required
  • Minimum 12 years' experience in pharmaceutical or biotech industry in quality or related role, with 5+ years in commercial-stage role
  • Demonstrated success managing quality and regulatory compliance in global environment
  • Strong GxP knowledge and understanding of relevant global regulatory requirements
  • Operational excellence and leadership abilities to drive quality initiatives and manage cross-functional teams
About Us

Syndax Pharmaceuticals is a clinical stage biopharmaceutical company developing innovative cancer therapies. We are committed to realizing a future where people with cancer live longer and better than ever before.



  • Waltham, Massachusetts, United States Lyra Therapeutics Full time

    About the RoleWe are seeking a highly experienced IT Director/Sr. Director to join our team at Lyra Therapeutics, Inc. As a functional partner to Quality and Manufacturing, you will play a critical role in selecting and implementing systems from the ground up in our brand new facility.The successful candidate will be part of a solution-centric technology...


  • Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time

    OverviewDeciphera 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 Deciphera Pharmaceuticals Full time

    Job 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...


  • Waltham, Massachusetts, United States ElevateBio Full time

    ElevateBio is a pioneering technology-driven company dedicated to accelerating the development of cutting-edge genetic medicines. With a comprehensive model that integrates multiple technologies, we offer turnkey scale and biotechnological capabilities to power genetic medicine processes, programs, and companies.The RoleIn this key position, you will support...


  • Waltham, Massachusetts, United States Lifelancer Full time

    Lead 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...


  • Waltham, Massachusetts, United States YMCA of Greater Boston Full time

    The YMCA of Greater Boston is seeking an experienced Aquatics Leadership Director to lead the development and implementation of high-quality swim programs. This role will play a critical part in creating a transformative experience for program participants, families, members, and staff.About the RoleThis position reports directly to the Sr. Aquatics Director...


  • Waltham, Massachusetts, United States eTeam Full time

    About eTeameTeam is a dynamic organization that offers challenging opportunities for growth and development.Salary Range$80,000 - $110,000 per annum, depending on experience.About the JobWe are seeking a highly skilled Documentation Specialist Lead to join our team. This role will play a key part in ensuring the quality of our documentation processes and...


  • Waltham, Massachusetts, United States YMCA of Greater Boston Full time

    About the RoleThe Swim Development Director is a vital member of our Aquatic Department at the YMCA of Greater Boston. Reporting to the Sr. Aquatics Director, you will lead the development and implementation of high-quality swim programs that meet the needs of our community, while maintaining the YMCA's standards of quality, safety, and caring.Main...


  • Waltham, Massachusetts, United States ESFM® USA Full time

    Company Overview:ESFM USA is a leading provider of facilities management services, dedicated to delivering exceptional results to our clients.About the Role:We are seeking an experienced Director of Facilities Management and Operations to lead our team in ensuring the smooth operation of our facilities. The successful candidate will be responsible for...


  • Waltham, Massachusetts, United States Mass General Brigham Incorporated Full time

    Medical Director Job Opportunity at Mass General BrighamAbout the Role:We are seeking a highly skilled Medical Director to lead our outpatient primary care practice at Mass General Brigham. As a key member of the clinical team, the Medical Director will provide the full scope of primary care services and report to the Director of Primary...


  • Waltham, Massachusetts, United States ClinLab Staffing Full time

    Clinical Trials Operations Director OpportunityAt ClinLab Staffing, we are seeking an experienced Clinical Trials Operations Director to lead our clinical trials operations team. This is a dynamic and challenging role that requires strong leadership and management skills.About the Role:The Clinical Trials Operations Director will be responsible for...


  • Waltham, Massachusetts, United States YMCA of Greater Boston Full time

    About the RoleWe are seeking a skilled Aquatics Program Director to lead our competitive and pre-competitive swim programs. This role is an exciting opportunity for a motivated professional with expertise in swim development techniques, program implementation, and team management.ResponsibilitiesDevelop and implement high-quality swim programs that meet...


  • Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time

    Company OverviewDeciphera Pharmaceuticals, a member of ONO, is a leading biopharmaceutical company dedicated to discovering, developing, and commercializing innovative new medicines to improve the lives of people with cancer.We leverage our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a diverse...


  • Waltham, Massachusetts, United States Mass General Brigham Incorporated Full time

    Mass General Brigham Incorporated is seeking a highly skilled and experienced Medical Director to lead our outpatient primary care practice in Waltham, MA.About the RoleThe Medical Director will oversee the full scope of primary care services, including diagnosis, treatment, coordination of care, preventive care, and health maintenance for patients. As a key...


  • Waltham, Massachusetts, United States Integrated Resources Full time

    Job 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 Deciphera Pharmaceuticals Full time

    Job Title: Field Access DirectorWe are seeking a highly experienced and results-driven Field Access Director to join our US Market Access Team at Deciphera Pharmaceuticals.About UsDeciphera Pharmaceuticals is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer....


  • Waltham, Massachusetts, United States Mass General Brigham Full time

    OverviewMass General Brigham is a leading healthcare system seeking a skilled Medical Director of Laboratory and Surgical Pathology to lead our laboratory team in Waltham, Massachusetts.We are committed to providing high-quality care to our patients and communities, and we believe that this role will play a critical part in helping us achieve this...


  • Waltham, Massachusetts, United States RPM ReSearch Full time

    Job 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...


  • Waltham, Massachusetts, United States Mindlance Full time

    Quality 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...


  • Waltham, Massachusetts, United States Mass General Brigham Full time

    About the RoleWe are seeking a highly skilled Laboratory Director and Pathology Specialist to lead our laboratory and surgical pathology departments at Mass General Brigham. This is an exciting opportunity for a talented professional to join our team and contribute to delivering high-quality patient care.Job DescriptionThe successful candidate will be...