Agilent Technologies

Agilent Technologies

Director Quality Science & Technology

Canada-Prince Edward Island-Charlottetown · Director · Full-time

Sponsorship not specified$131k-$205kDetected 11 days ago
Product ManagementSupply ChainProcess ImprovementGMPFDA RegulatoryLeadershipRegulatory Affairs

About the role

  • The role operates with significant autonomy, influencing outcomes through governance, technical authority, and executive partnership, rather than direct line management.
  • Additional Details This job has a full time weekly schedule.
  • It includes the option to work remotely.

Responsibilities

  • Partner with PD, MS&T, Manufacturing, Engineering, QC, Clients and Regulatory teams to establish quality Principles in to process development, scale-up, technology transfer and life cycle management.
  • Develop quality Engineers team to support client needs, compliance and regulatory requirements.
  • Lead quality assessment of change controls, ensuring appropriate risk evaluation, impact assessment, validation requirement and implementation strategies are defined all changes.
  • Maintain and evolve the Quality Management System (QMS) in alignment with complex chemistry molecules and biological drug substances, reagents regulatory requirements and applicable international standards.
  • Identify and address systemic gaps that drive variability in compliance, product performance, or post‑market outcomes.
  • Drive data‑driven continuous improvement using post‑market surveillance data, complaints, nonconformances, inspections, and audit outcomes.
  • Lead initiatives to reduce Cost of Poor Quality (COPQ) while strengthening product reliability, compliance sustainability, and patient/user safety.
  • Build and develop high‑performing QS&T and quality engineering teams with strong regulatory, technical, and risk‑based decision‑making capabilities.
  • Provide strategic quality leadership and influence across teams to drive a proactive quality culture and effective risk-based approaches.
  • Lead complex quality discussions and facilitate alignment across manufacturing, QC, Manufacturing PD, MS&T, Regulatory, Engineering and Operations to enable complaint business decisions.

Requirements

  • 10+ years of experience in quality and technical operations, Process Development or manufacturing within biological and pharmaceutical environments.
  • Deep knowledge of complex chemistry and biological products system principles, risk management, validation, supplier quality, and statistical methods.
  • Working knowledge of regulatory expectations (ICH,HC, FDA), GMP requirements, inspection readiness and applicable quality systems.
  • Travel Required:
  • Bachelor's degree in engineering, Life Sciences, or a related discipline required; Master's or PhD preferred
  • Demonstrated success managing quality and regulatory risk across biologics, peptides/polypeptides or complex biological product lifecycles, including development, launch, and post‑market sustainment.
  • Proven ability to lead through influence, governance, and technical expertise in complex, global, matrixed organizations including CDMOs.
  • Additional Details
  • This job has a full time weekly schedule. It includes the option to work remotely.
  • The full-time equivalent pay range for this position is $130,944.00 - $204,600.00/yr CAD plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations
  • Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.
  • Occasional

Nice to have

  • Bachelor's degree in engineering, Life Sciences, or a related discipline required
  • Master's or PhD preferred
  • ASQ certifications and/or Six Sigma credentials preferred.

Skills

  • https://careers.agilent.com/locations
  • Agilent Technologies Inc. is an equal opportunity employer.

Compensation

  • The full-time equivalent pay range for this position is $130,944.00 - $204,600.00/yr CAD plus eligibility for bonus, stock and benefits.

Benefits

  • Monitor post‑launch performance and champion preventive and systemic actions that improve long‑term portfolio health and regulatory resilience.
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