Senior Specialist, Quality Assurance

3 weeks ago

Hamilton, Canada BrainChild Bio Full time

Join to apply for the Senior Specialist, Quality Assurance role at BrainChild Bio Base pay range $150,000.00/yr - $190,000.00/yr 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. Seniority level Mid‑Senior level Employment type Contract Job function Quality Assurance #J-18808-Ljbffr

  • Senior Specialist, Quality Assurance

    3 weeks ago

    Hamilton, Canada BrainChild Bio Full time

    Join to apply for the Senior Specialist, Quality Assurance role at BrainChild Bio Base pay range $150,000.00/yr - $190,000.00/yr 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...

  • Senior Specialist, Quality Assurance

    3 weeks ago

    Hamilton, Canada BrainChild Bio Full time

    Join to apply for the Senior Specialist, Quality Assurance role at BrainChild Bio Base pay range $150,000.00/yr - $190,000.00/yr 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...

  • Senior Specialist, Quality Assurance

    3 days 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...

  • Senior Specialist, Quality Assurance

    3 days ago

    Hamilton, Ontario, Canada BrainChild Bio Full time $80,000 - $120,000 per year

    BrainChild Bio is seeking aSenior 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...

  • Senior Specialist, Quality Assurance

    3 weeks ago

    Hamilton, Canada BrainChild Bio, Inc. 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...

  • Senior Specialist, Quality Assurance

    3 weeks ago

    Hamilton, Canada BrainChild Bio, Inc. 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...

  • Quality Assurance Specialist

    5 days ago

    Hamilton, Canada The Fedcap Group Full time

    **Position Summary**: The Quality Assurance Specialist of the Fedcap Canada team is responsible for monitoring, inspecting, and proposing measure to correct or improve the organizations products and processes to meet the organizations established quality standards. **Essential Job Responsibilities**: - Assist the Quality Assurance Director on the quality...

  • Quality Assurance Specialist

    5 days ago

    Hamilton, Canada The Fedcap Group Full time

    **Position Summary**: The Quality Assurance Specialist is responsible for ensuring Fedcap Canada’s established program and organization quality standards are achieved. Working within a wider team, this position provides a critical business function that monitors all elements of our delivery, challenges status quo and supports continuous improvement...

  • Senior Software Quality Assurance Specialist

    4 weeks ago

    Toronto, Montreal, Calgary, Vancouver, Edmonton, Old Toronto, Ottawa, Mississauga, Quebec, Winnipeg, Halifax, Saskatoon, Burnaby, Hamilton, Victoria, Surrey, Halton Hills, London, Regina, Markham, Brampton, Vaughan, Kelowna, Laval, Southwestern Ontario, R, Canada PrecisionERP PrecisionIT Full time

    Senior Software Quality Assurance Specialist Contract: Lead Quality Assurance Analyst / Tester Location: Remote from Canada Duration: 12 months Start Date: December 01, 2025 Work hours: full-time 7.25-hour workday, Mon - Fri 8:15 - 4:30 AST Mandatory Requirements A University degree in Computer Science, Health Sciences, Business Administration or similar...

  • NDE & Quality Assurance Specialist (ISO/AS9100)

    3 weeks ago

    Hamilton, Canada Liburdi Turbine Services Inc. Full time

    A reputable engineering firm in Ontario is seeking a qualified NDE / Quality Specialist. This full-time position involves maintaining and improving quality systems, supporting NDE processes, and conducting internal audits. Ideal candidates hold a degree in Engineering or Quality Assurance and possess at least 5 years of relevant experience. The company...