Senior Specialist, Quality Assurance

2 weeks ago

Hamilton, Ontario, Canada BrainChild Bio Full time

BrainChild Bio is seeking a
Senior Specialist, Quality Assurance
, to serve as our on-site Quality representative at our contract manufacturing partner (CDMO). This role will act as BrainChild Bio's primary Quality presence at our CDMO, providing Quality Assurance oversight and support of all BrainChild Bio-related activities. The Senior Specialist will provide operational Quality support at the CDMO and act as a project manager, coordinating with BrainChild Bio's Patient Operations team to track status of in-process autologous CAR T batches. Key responsibilities include timely lot disposition and shipment, upcoming batch readiness, and comprehensive Quality and Operations support for in-process lots.

The ideal candidate brings Quality Assurance experience, strong organizational and project management skills, and exceptional communication. We're seeking a collaborative leader who can orchestrate cross-functional, complex workflows with our CDMO, hold themselves and others to the highest standards of compliance, and help bring BrainChild Bio's life-changing therapies to patients.

Responsibilities:

  • Represent BrainChild Bio at our CDMO partner as the lead for documentation review, lot disposition, and deviation and investigational support.
  • Work with the CDMO to track manufacturing, testing, and release operations to drive compliant and consistent cadence of operations and delivery of product to patients.
  • Provide appropriate oversight and ensure compliance with all applicable GMP regulations at BrainChild Bio and our CDMO.
  • Partner with BrainChild Bio Quality, Patient Operations, and Program Management leadership to manage and track key quality system metrics, analytics, and reports pertaining to BrainChild Bio product manufacturing and proactively identify and propose potential solutions to address issues.
  • Deliver Quality guidance to BrainChild Bio program teams during manufacturing activities and product development.
  • Compile and deliver information for routine Quality Management Reviews with senior leadership.
  • Participate in and bring an active voice to inspection readiness activities as BrainChild Bio and the CDMO partner build toward late stage clinical and commercial readiness.

Qualifications:

  • 5+ years of experience in a Quality role in the biotech/cell therapy industry.
  • 1+ years supporting manufacturing operations in a Quality role.
  • Knowledge and application experience of cGMPs in biotech manufacturing.
  • Strong communication skills and robust project management skills.
  • Audit experience, leading and participation in, a plus.
  • Ability to deliver in a fast paced, small company environment and adjust workload based on shifting priorities and needs.
  • Must be able to work onsite in Hamilton, CA on a consistent basis

  • Senior Specialist, Quality Assurance

    2 weeks ago

    Hamilton, Ontario, Canada BrainChild Bio Full time US$150,000 - US$190,000

    BrainChild Bio is seeking a Senior Specialist, Quality Assurance, to serve as our on-site Quality representative at our contract manufacturing partner (CDMO). This role will act as BrainChild Bio's primary Quality presence at our CDMO, providing Quality Assurance oversight and support of all BrainChild Bio-related activities. The Senior Specialist will...

  • TEMP Quality Assurance and Compliance Lead

    1 week ago

    Hamilton, Ontario, Canada The Fedcap Group - Canada Full time

    Position Summary:The TEMP Quality Assurance and Compliance Lead will lead the design, implementation, and continuous improvement of Fedcap Canada's enterprise-wide Quality Assurance and Compliance programs. This high-impact leadership role is responsible for ensuring measurable quality standards across all critical service delivery touchpoints, maintaining...

  • TEMP Quality Assurance and Compliance Lead

    1 week ago

    Hamilton, Ontario, Canada The Fedcap Group Full time

    Position SummaryJOB DESCRIPTIONThe TEMP Quality Assurance and Compliance Lead will lead the design, implementation, and continuous improvement of Fedcap Canada's enterprise-wide Quality Assurance and Compliance programs. This high-impact leadership role is responsible for ensuring measurable quality standards across all critical service delivery touchpoints,...

  • Quality Assurance Auditor Lead

    1 week ago

    Hamilton, Ontario, Canada KF Aerospace Full time

    We're all about the craft.KF Aerospace is proud to deliver innovative aircraft services for corporate, commercial, and military customers worldwide. Launched in 1970 out of British Columbia's beautiful city of Kelowna, KF has grown to specialize in a wide range of aviation services including maintenance and modifications, cargo operations, military pilot...

  • Quality Assurance Intern

    2 weeks ago

    Hamilton, Ontario, Canada AtomVie Global Radiopharma Inc. Full time

    AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients' lives by advancing high quality drugs for the treatment and diagnosis of diseases.We are a community that challenges ourselves professionally, takes pride in what we can...

  • Clinical Trials Quality Specialist

    2 weeks ago

    Hamilton, Ontario, Canada Hamilton Health Sciences Full time

    The Quality Specialist, in collaboration with the Research Compliance and Support Services department (RCSS) and RCSS Manager, shall be responsible for executing a comprehensive Quality Management System (QMS) that includes:a) Quality Systems, Risk Management, and Regulatory Complianceb) Implement and Oversee Quality Management Systemc) Continuous Quality...

  • Job ID #31535: Quality Assurance Analyst

    3 days ago

    Hamilton, Ontario, Canada City of Hamilton Full time

    Contribute to the City of Hamilton, one of Canada's largest cities - home to a diverse and strong economy, an active and inclusive community, a robust cultural and dining scene, hundreds of kilometers of hiking trails and natural beauty just minutes from the downtown core, and so much more. Join our diverse team of talented and ambitious staff who embody our...

  • Senior Employee

    1 week ago

    Hamilton, Ontario, Canada Hamilton Health Sciences Full time

    Senior Employee & Labour Relations SpecialistPlease apply via and search for Requisition # 121861HHS Requisition # 121861Status:Regular Full-TimeHours per Week:37.5Rate: $ $64.56 HourlyUnit SummaryHuman Resources is dedicated to cultivating the optimal environment and culture to achieve organizational goals. This is achieved through the highest quality of...

  • Application Specialist

    2 weeks ago

    Hamilton, Ontario, Canada Hamilton Health Sciences Full time

    The Application Specialist (EPIC) is responsible for the administration of EPIC including configuration and administration of the software system in support of end user, design and develop custom software solutions using a wide variety of development tools and database technologies, ensuring that appropriate standards, education, processes, systems and...

  • Senior Accounting Manager

    1 week ago

    Hamilton, Ontario, Canada Hays Full time

    Senior Manager – Assurance & Accounting | Hamilton, ONLocation:Hamilton, ONAbout the CompanyJoin a well-established professional services firm with a strong reputation for delivering exceptional accounting, assurance, and tax solutions. Serving a diverse client base—including private enterprises and not-for-profit organizations—our client is known for...