Director, Quality Assurance Operations

1 month ago

Waltham, United States ElevateBio Full time

ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.

The Role:

The Director of QA Operations is responsible for quality assurance oversight of the daily operational activities for the manufacturing and testing of the cell and gene therapy products at our BaseCamp facility in Waltham, MA. This role provides leadership to ensure that cGMPs are maintained and product is manufactured at the highest quality. This individual will implement and continuously improve policies, standards, procedures, practices and systems to ensure manufacturing operations are compliant with global cGMP regulations. The incumbent manages the team responsible for providing day-to-day Quality oversight of clinical manufacturing operations, including QA review and approval of Batch Records, Deviations, Laboratory Investigations, Lot Disposition, and providing on-the-manufacturing-floor QA support.

Here's What You'll Do:

  • Lead a team of QA managers and individual contributors to support routine cGMP operations with an effective QA on-the-floor support function for critical cell and gene therapy manufacturing activities, bringing a strong compliance and quality mindset to a complex manufacturing environment.
  • Ensure cohesive collaboration across QA Operations and Manufacturing for thorough and timely review of manufacturing records, enabling right-first-time batch record review and on-time batch disposition with a high level of efficiency and quality.
  • Interface with internal and external clients regarding Quality Assurance, Product Lifecycle and continuous improvement topics.
  • Collaborate with QA Validation, Manufacturing Science & Technology, Manufacturing, Facilities & Engineering, and QC for the successful technical transfer of manufacturing processes into routine production, leveraging risk management tools to identify operational risks and associated mitigation control strategies.
  • Responsible for the management of the cross-functional sterility assurance and contamination control program.
  • Participate with other Quality functions and Management for client interactions and communications.
  • Establish and communicate performance objectives for QA Operations staff that are consistent with corporate and Quality goals and objectives.
  • Provide training, constructive feedback and a collaborative environment that attracts, develops and retains the best talent
  • Develop, monitor and improve Quality policies, procedures and processes to meet cGMP regulatory guidance and the growing needs of the organization
  • Foster a quality mindset by ensuring consistent, risk-based and innovative thought processes are employed to advise and make decisions
  • Lead and manage complex projects/teams within corporate objectives and project timelines and participate in cross-functional projects as a Quality subject matter expert.
Requirements:
  • Bachelor's degree in a scientific discipline with at least 12 years of experience in a pharmaceutical, biotechnology or biologics operation, including 7 years of Quality experience.
  • Experience with manufacturing of Cell & Gene Therapy Products and with Sterility Assurance Programs preferred.
  • Experience in working in a Contract Manufacturing environment preferred.
  • Working knowledge and demonstrated ability to apply GMPs across early and late clinical phases.
  • Excellent communication skills with a customer service mindset.
  • Strong leadership, teamwork and problem-solving skills.
  • Experience leading and training others in root cause investigations, deviations, OOS and CAPA.
  • Strong knowledge with aseptic manufacturing process requirements
  • Technical proficiency & knowledge in use of enterprise electronic data management and execution systems (i.e. ERP, QMS, DMS, LIMS, and MES).


Why Join ElevateBio?

ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities. The ElevateBio ecosystem combines multiple R&D technology platforms - including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform - with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.

We aim to be the dominant engine inside the world's greatest scientific advancements harnessing human cells and genes to alter disease.

Our Mission:
To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.

Our Vision:
We seek to be the world's most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created and how disease is treated.

ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

  • Director of Quality Assurance Operations

    2 weeks ago

    Waltham, Massachusetts, United States ElevateBio Full time

    Director of Quality Assurance OperationsElevateBio is a technology-driven cell and gene therapy company that accelerates access to cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to...

  • Director of Quality Assurance

    2 weeks ago

    Waltham, Massachusetts, United States RPM ReSearch Full time

    Job SummaryThe Director of Quality Assurance is responsible for overseeing all aspects of the Quality Assurance function, including the development, implementation, and maintenance of an effective Quality Management System. This includes ensuring compliance with relevant regulations and standards, such as FDA and EMA guidelines.The ideal candidate will have...

  • Senior Director of Quality Assurance

    1 month ago

    Waltham, Massachusetts, United States TScan Therapeutics Full time

    Job Title: Senior Director of Quality AssuranceAbout the Role:TScan Therapeutics is seeking a highly experienced Senior Director of Quality Assurance to lead our Quality Assurance team and ensure the highest standards of quality in our GMP operations. As a key member of our Technical Operations and Quality team, you will be responsible for developing and...

  • Senior Director of Quality Assurance

    1 month ago

    Waltham, Massachusetts, United States TScan Therapeutics Full time

    Job Title: Senior Director of Quality AssuranceAbout the Role:TScan Therapeutics is seeking a highly experienced Senior Director of Quality Assurance to lead our Quality Assurance team and ensure the highest standards of quality in our GMP operations. As a key member of our Technical Operations and Quality team, you will be responsible for developing and...

  • Director of Quality Assurance and Pharmacovigilance

    1 month ago

    Waltham, Massachusetts, United States GQR Full time

    Job Title: Director, Clinical Quality Assurance, PharmacovigilanceJob Summary:GQR is seeking a highly experienced Director of Clinical Quality Assurance and Pharmacovigilance to lead our team in ensuring the highest standards of quality and safety in our pharmaceutical operations.Key Responsibilities:Develop and implement risk-based audit plans to ensure...

  • Director, Clinical Quality Assurance, Pharmacoviligance

    1 month ago

    Waltham, United States GQR Full time

    Title: Director, Clinical Quality Assurance, PharmacovigilanceStatus: Full time direct-hireLocation: Hybrid role, 3 days a week in Waltham, MASome travel is required, up to 25%Compensation: $225,000 base salary plus annual bonus and equity.The Director of CQA-PV is the supervisor of the Clinical Quality Assurance Department with responsibilities for quality...

  • Director, Clinical Quality Assurance, Pharmacoviligance

    1 month ago

    Waltham, United States GQR Full time

    Title: Director, Clinical Quality Assurance, PharmacovigilanceStatus: Full time direct-hireLocation: Hybrid role, 3 days a week in Waltham, MASome travel is required, up to 25%Compensation: $225,000 base salary plus annual bonus and equity.The Director of CQA-PV is the supervisor of the Clinical Quality Assurance Department with responsibilities for quality...

  • Director, Clinical Quality Assurance, Pharmacoviligance

    3 weeks ago

    Waltham, United States GQR Full time

    Title: Director, Clinical Quality Assurance, PharmacovigilanceStatus: Full time direct-hireLocation: Hybrid role, 3 days a week in Waltham, MASome travel is required, up to 25%Compensation: $225,000 base salary plus annual bonus and equity.The Director of CQA-PV is the supervisor of the Clinical Quality Assurance Department with responsibilities for quality...

  • Director of Clinical Quality Assurance and Pharmacovigilance

    7 days ago

    Waltham, Massachusetts, United States Alkermes Full time

    Job DescriptionThe Director of Clinical Quality Assurance and Pharmacovigilance is a senior leadership position responsible for overseeing the Clinical Quality Assurance Department and ensuring the quality of Post Marketing Good Pharmacovigilance Practices (GPvP) and Commercial Operations. This role is responsible for developing and implementing strategies...

  • Director of Quality Operations

    2 weeks ago

    Waltham, Massachusetts, United States Mural Oncology Full time

    Job Title: Director Quality OperationsMural Oncology is a clinical-stage oncology company focused on discovering and developing immunotherapies that may improve the lives of patients with cancer. Our team is dedicated to ensuring compliance and excellence across all research and development activities, encompassing Good Clinical Practice (GCP), Good...

  • Senior Director of R&D Quality Assurance

    1 month ago

    Waltham, Massachusetts, United States Apellis Full time

    Job Title: Senior Director of R&D Quality AssuranceApellis Pharmaceuticals, Inc. is seeking a highly experienced Senior Director of R&D Quality Assurance to lead our global R&D QA function. As a key member of our Quality Leadership Team, you will be responsible for establishing and implementing the strategy for R&D QA, ensuring compliance with global...

  • Director of Quality Operations

    4 weeks ago

    Waltham, Massachusetts, United States Mural Oncology Full time

    Job Title: Director Quality OperationsMural Oncology is a clinical-stage oncology company focused on discovering and developing immunotherapies that may improve the lives of patients with cancer. Our team is dedicated to ensuring compliance and excellence across all research and development activities, encompassing Good Clinical Practice (GCP), Good...

  • Senior Director of R&D Quality Assurance

    1 month ago

    Waltham, Massachusetts, United States Apellis Full time

    Job Title: Senior Director, R&D QAJob Summary:The Senior Director of R&D Quality Assurance will be responsible for establishing and implementing the strategy for the R&D QA function at Apellis. This individual will partner with senior management and stakeholders to develop risk-based, phase-appropriate strategies to ensure that clinical trials and...

  • Design Assurance Director

    7 days ago

    Waltham, Massachusetts, United States Boston Scientific Full time

    Job SummaryBoston Scientific is seeking a highly skilled Design Assurance Director to lead our Electrophysiology Systems team. As a key member of our organization, you will be responsible for ensuring product quality and compliance through the application of Design Control and Risk Management.Key ResponsibilitiesLead quality team on product/system...

  • Design Assurance Director

    7 days ago

    Waltham, Massachusetts, United States Boston Scientific Full time

    About the Role:The Design Assurance Director will serve as the Site Head of Quality (SHOQ) in our Waltham MA and Montreal design sites and will have primary Quality Assurance leadership/oversight for the rapidly growing Pulse Field Ablation (PFA) Franchise, having a direct interaction with Montreal, Heredia and Arden Hills sites.This is an exciting...

  • Director of Quality Operations

    2 weeks ago

    Waltham, Massachusetts, United States Mural Oncology Full time

    Mural Oncology is seeking a highly experienced and skilled Director of Quality Operations to join our team. As a key member of our Quality organization, you will be responsible for overseeing and managing Quality Operations activities for the manufacture of master cell bank, working cell bank, drug substance, and drug product/finished goods.This role...

  • Director Quality Operations

    1 month ago

    Waltham, United States Mural Oncology Full time

    Mural Oncology is a clinical-stage oncology business focused on discovering and developing immunotherapies that may meaningfully improve the lives of patients with cancer. By leveraging its core competencies in immune cell modulation and protein engineering, Mural Oncology has developed a portfolio of novel, investigational cytokine therapies designed to...

  • Director Quality Operations

    22 hours ago

    Waltham, United States Mural Oncology Full time

    Mural Oncology is a clinical-stage oncology business focused on discovering and developing immunotherapies that may meaningfully improve the lives of patients with cancer. By leveraging its core competencies in immune cell modulation and protein engineering, Mural Oncology has developed a portfolio of novel, investigational cytokine therapies designed to...

  • Quality Assurance Specialist

    2 weeks ago

    Waltham, Massachusetts, United States Advantage Technical Full time

    Job SummaryThe Quality Assurance Specialist will be responsible for supporting Global Quality Systems and their operations in ensuring compliance and fit for intended use per applicable global SOPs. This role will focus on the governance of Quality System applications, including harmonization of processes across sites.Key ResponsibilitiesEnsure the system is...

  • Senior Director, GMP Quality Operations

    4 weeks ago

    Waltham, Massachusetts, United States BioSpace, Inc. Full time

    Job Title: Senior Director, GMP Quality OperationsAt Dyne Therapeutics, we are seeking a highly experienced Senior Director to lead our GMP Quality Operations team. As a key member of our Quality department, you will be responsible for ensuring the quality of our external manufacturing operations globally and internal GMP operations for development and...