Associate Director Quality Management

Lifelancer Ltd

Kirkland

Hybrid

CAD 120,000 - 180,000

Full time

3 days ago
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Job summary

Lifelancer Ltd in Kirkland, Quebec, Canada, is seeking an Associate Director of Quality Management to lead a Regional Clinical Compliance team supporting country- and site-level oversight. This role combines people leadership with strategic accountability to ensure risk-based compliance activities are executed with excellence in a remote working model.

You will drive continuous improvement, monitor KPIs, and collaborate with Global Clinical Compliance and Quality Assurance to align local

Qualifications

  • Bachelor’s degree in a scientific/healthcare field with 8+ years in clinical operations and 6+ years in GCP compliance.
  • Proven people leadership experience across multi-country teams.
  • Deep knowledge of ICH-GCP, SOPs, and regulatory requirements.

Responsibilities

  • Lead the RCC country compliance managers team across multiple countries.
  • Oversee inspections, audits and CAPA processes.
  • Drive standardization of processes and cross-functional partnerships.

Skills

GCP compliance
People management
Clinical operations
Regulatory knowledge
Quality assurance
Analytical skills
Communication

Education

Bachelor's degree in scientific/healthcare field

Job description

Job Title: Associate Director Quality Management

Job Location: Kirkland, Quebec, Canada

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level: General

General Description: The Regional Clinical Compliance Lead is responsible for leading, developing, and managing a team of Clinical Compliance professionals supporting country- and site-level oversight. This role combines people leadership with operational and strategic accountability to ensure consistent, high-quality execution of risk-based compliance activities. This role plays a critical role in building team capability, driving performance, and ensuring alignment with global compliance strategies while fostering a culture of quality, accountability, and continuous improvement.

Essential Functions
  • Serve as the primary point of contact for the RCC country compliance managers team regarding:
    • GCP requirements
    • Company and study-specific procedures
    • General compliance-related queries
    • Provide expert guidance and interpretation of regulations and internal standards to ensure consistent and compliant practices.
  • Oversee preparation, execution, and follow-up activities for inspections
  • Provide leadership support during high-impact audits and inspections.
  • Ensure consistent application of lessons learned across the team.
Operational Oversight & Execution Excellence
  • Ensure consistent and high-quality execution of risk-based compliance activities across countries and studies.
  • Monitor key performance indicators (KPIs), quality metrics, and compliance trends across the team- Identify systemic risks, recurring issues, and areas for improvement.
  • Ensure timely escalation to Head RCC EMEA and effective resolution of critical compliance issues.
  • Drive accountability for CAPA quality and effectiveness.
  • Provide oversight and quality review of:
    • Remote Compliance Activities
    • Risk identification and mitigation strategies
    • Site-level compliance assessments
  • Drive standardization and harmonization of processes across the team.
Resource & Capacity Management
  • Manage and oversee the budget, resource allocation and workload balancing across the team based on study portfolio and risk profile.
  • Ensure appropriate resourcing for high-risk studies, sites, and compliance activities.
  • Partner with senior leadership on workforce planning and capability needs.
Strategic Alignment & Cross-Functional Partnership
  • Translate global compliance strategies into clear team-level objectives and actions.
  • Ensure alignment between local execution and global expectations by partnering with:
    • RCC Inspection and Audit Lead
    • RCC Process Excellence and Risk Surveillance
    • Global Clinical Compliance
    • Clinical Operations leadership
    • Quality Assurance teams
  • Represent the function in governance forums and cross-functional discussions.
Core Competencies, Knowledge and Skill Requirements:
  • Understanding of clinical trial processes with a thorough knowledge of ICH-GCP and associated regulatory guidelines
  • Analytical and problem-solving skills
  • High attention to detail and quality orientation
  • Excellent communication and stakeholder management skills
Communication & Interpersonal Skills:
  • Excellent English written and verbal communication and interpersonal skills
  • Excellent organizational skills and ability to prioritize and multi-task
  • Ability to work independently in multi-cultural setting and effectively handle multiple priorities in a fast-paced environment
Supervisory Responsibilities:
  • Lead, coach, and develop a team of Regional Clinical Compliance professionals across multiple countries.
  • Set clear performance expectations and conduct regular performance reviews (goal setting, mid-year, year-end).
  • Build organizational capability by identifying skill gaps and implementing targeted development plans.
  • Foster a culture of quality, accountability, continuous improvement, and psychological safety.
  • Drive talent management, including succession planning and retention of key talent.
  • Promote an inclusive, collaborative, and high-performing team environment aligned with company values.
  • Encourage feedback, innovation, and continuous learning.
  • Model ethical behavior and reinforce a compliance mindset across the team.
Qualifications
  • Bachelor's degree (BS/BA or equivalent) or higher in a scientific, medical or healthcare discipline* with minimum of 8 years of progressive experience in clinical operations roles plus minimum 6 years' experience in a GCP compliance or equivalent role (i.e. quality) including people management experience (minimum 4 years).
  • Experience in oncology global trials is preferred.
  • Requires deep knowledge of one or more related job areas typically obtained through advanced education combined with experience.
  • Sound working knowledge of relevant terminology, International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), applicable regulatory requirements, quality
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