Senior Specialist, Quality Assurance

1 day ago

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

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 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...

  • Quality Specialist

    1 week ago

    Hamilton, Ontario, Canada Hamilton Health Sciences Full time $60,000 - $90,000 per year

    Reporting to the Director of Child and Youth Ambulatory Services, the Quality Specialist plays a key role in advancing quality improvement across the ambulatory programs at McMaster Children's Hospital and the Ron Joyce Children's Health Centre. This role is responsible for identifying, designing, planning, executing, and evaluating program initiatives aimed...

  • Quality Assurance Technician

    1 day ago

    Hamilton, Ontario, Canada Venetian Meat & Salami Co Ltd. Full time

    Company DescriptionVenetian Meats and Salami Co. Ltd. is a family-owned company producing dry cured and cooked sausage products located in Hamilton, Ontario. As an established meat processing company, we are continually growing our team by seeking a talented individual to fill a full-time contract position as an QA Technician.·       Support and...

  • Quality Specialist

    1 week ago

    Hamilton, Ontario, Canada Hamilton Health Sciences Full time $120,000 - $150,000 per year

    1. Master's degree in a relevant field (e.g., Health Administration, Health Sciences, Public Health, Business Administration, Industrial Engineering, or related discipline).2. Advanced knowledge and/or certification in quality improvement methodologies and tools (e.g., Lean, Six Sigma, Model for Improvement).3. Demonstrated experience in healthcare settings,...

  • Quality Specialist

    5 days ago

    Hamilton, Ontario, Canada Hamilton Health Sciences Full time $60,000 - $80,000 per year

    1. Master's degree in a relevant field (e.g., Health Administration, Health Sciences, Public Health, Business Administration, Industrial Engineering, or related discipline).2. Advanced knowledge and/or certification in quality improvement methodologies and tools (e.g., Lean, Six Sigma, Model for Improvement).3. Demonstrated experience in healthcare settings,...

  • Quality Specialist

    1 week ago

    Hamilton, Ontario, Canada Hamilton Health Sciences Full time $80,000 - $120,000 per year

    Monday to Friday days, (some evenings and weekends may be required)This position is temporary until January 2027Step into a job that opens countless doors. As Ontario's most comprehensive healthcare system, providing care from pre-birth to end of life, Hamilton Health Sciences (HHS) offers endless opportunities. You can explore advancement, take professional...

  • Quality Assurance Intern

    2 weeks ago

    Hamilton, Ontario, Canada AtomVie Global Radiopharma Inc. Full time $45,000 - $60,000 per year

    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...

  • Quality Assurance Intern

    1 day ago

    Hamilton, Ontario, Canada AtomVie Global Radiopharma Inc. Full time $35,000 - $50,000 per year

    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

    1 day ago

    Hamilton, Ontario, Canada Hamilton Health Sciences Full time $60,000 - $80,000 per year

    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...

  • Quality Assurance Coordinator

    2 days ago

    Hamilton, Ontario, Canada Hamilton Health Sciences Full time US$60,000 - US$90,000 per year

    1. A health related degree or equivalent2. Previous experience in clinical quality assurance or coordination of clinical trials/research3. Excellent communication skills, both oral and written4. Excellent computer skills in all Microsoft Office applications5. Position ideally suited to a well-organized individual6. Sound knowledge of Canadian, US, and EU...