Manager, Quality Assurance, Process Validation

STEMCELL Technologies

Job Description Summary

Are you a visionary leader in Process Validation, eager to steer the course of operational excellence and compliance strategy in the dynamic realm of STEMCELL? As a Manager in our Quality department, your critical thinking skills will be put to the test as you focus on developing robust strategies across our cGMP product manufacturing landscape. You would be responsible for ensuring compliance with company standards and regulatory requirements, shaping the future of our quality framework. You are an inspirational member of the team, leading by example and ensuring cross-departmental conversations are evolving and growing when translating complex data sets into action.

Job Description

Duties and Responsibilities

  • Developing and applying innovative approaches and processes to validation strategies
  • Interacting with cross-functional managers and Sr. Leadership to build a broad-based validation program
  • Overseeing the Validation Program for cGMP manufacturing of ancillary materials
  • Develop and drive validation master plans, prepare protocols, analyze test results, and prepare technical reports
  • Oversee process validation deliverables for our in-house cGMP manufacturing and contract manufacturing organizations
  • Leading the Continued Process Verification (CPV) program

Knowledge and Qualifications

  • A minimum of a Bachelor’s Degree with at least 8 years of GxP experience in a pharmaceutical, biotechnology, or medical device industry
  • 5 years of experience executing validation projects for biotech or pharmaceutical production projects is required
  • Experience in biologics manufacturing would be an asset
  • Strong knowledge of cGMP’s 21 CFR Part 210 & 211, GAMP 5, EU Annex 11, ICH Q7, Q8, Q9, or equivalent industry guidance
  • Commissioning, Qualification, and Validation (CQV) expert in facilities, clean utilities, upstream and downstream biotech equipment, single-use disposables, or aseptic fill finish manufacturing

#Nonbench #LI-Hybrid #LI-ML1

STEMCELL Technologies is a privately owned, Vancouver-based biotechnology company that helps power leading-edge life science research around the world. Driven by our love of science and passion for quality, we are a company of Scientists Helping Scientists—standing by our customers to provide the outstanding products, technical support, and training they need to advance their research. Scientists performing stem cell, immunology, cancer, regenerative medicine, and cellular therapy research are among those who rely on our cell culture media, cell separation products, instruments, accessory products, and services. Through our many regional offices, as well as our distribution centers in Vancouver, Seattle, Grenoble, and Singapore, we deliver our innovative, specialized products to more than 100 countries. With over 2300 employees globally, most with scientific or engineering degrees, STEMCELL is proud to be the largest biotechnology employer in Canada.

This is an opportunity to work with highly motivated colleagues in a science-oriented, creative, and dynamic environment. We offer a competitive salary, excellent benefits, and meaningful career development opportunities.

STEMCELL is well recognized for exceptional leadership and business practices. We are one of Canada’s Best Managed Companies and operate an ISO 14001-certified environmental management system to measure and reduce our environmental impact. 

As an equal opportunity employer, STEMCELL is dedicated to ensuring that every employee feels safe, valued, and respected for who they are. We know that scientific progress and innovation occur when diverse, creative minds come together and we are committed to nurturing a culture of inclusivity and belonging. STEMCELL enforces a zero-tolerance policy for any form of discrimination. Selection decisions are solely based on job-related factors.

The annual base salary for this job ranges from:

$95,200.00 – $142,800.00

STEMCELL determines an individual’s pay within the range based on multiple factors including experience, education, job-related skills, and equity within the team or organization. For jobs that are eligible for sales incentives, the range noted above is inclusive of target incentives; actual incentives are based on individual performance results in accordance with company policy. In addition to base salary, STEMCELL offers a comprehensive total rewards package including health benefits, retirement savings, and more.

NOTE: STEMCELL’s vaccination policy requires that all candidates for this role be fully vaccinated against COVID-19 (including boosters), as currently recommended or required by local health authorities and public health orders, unless an exemption from this policy is approved through our accommodation request process.

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