Quality Assurance Director for Global Operations

4 days ago

London, Greater London, United Kingdom Lifelancer Full time
Company Overview

Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT that connects professionals with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

Salary

The estimated annual salary for this position is around $150,000-$180,000 based on the job requirements and industry standards.

Job Description

Job Title: Quality Assurance Director for Global Operations

Job Location: Remote

Job Type: Full-time

Job Seniority Level: Director

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

We are seeking a seasoned Quality Assurance Director to lead our global operations. This role will play a pivotal part in ensuring consistent implementation and alignment of global quality policies, procedures, and GxP standards at local and regional levels.

Required Skills and Qualifications

Essential Functions Of The Job:

  • Ensure global quality policies, procedures, and regulatory requirements are consistently applied at local affiliate and regional levels.
  • Support affiliates in embedding fit-for-purpose QMS that are aligned with both global processes and local regulatory requirements, ensuring procedural consistency and compliance.
  • Drive harmonization across local, regional, and global operations to ensure efficient alignment and execution of quality standards.
  • Help drive implementation of Risk Based Quality Management and Quality by Design principles.
  • Act as a key liaison between global headquarters and local affiliates, providing guidance and support in the development, implementation, and maintenance of local QMS.
  • Assist local teams in identifying areas for improvement in their quality systems, ensuring alignment with global standards while addressing local intricacies and regulatory expectations.
  • Provide training, resources, and tools to local quality teams to enhance their operational efficiency and regulatory compliance.
  • Develop and maintain systems to track and monitor quality and compliance metrics across regions and affiliates, ensuring alignment with global standards.
  • Analyze performance data to identify trends, risks, and areas for improvement, prioritizing quality efforts in collaboration with local teams, study teams, and compound leads.
  • Use data-driven insights to proactively address areas of concern, ensuring that risk-based quality management (RBQM) principles are applied.
  • Partner with key stakeholders, including RBQM teams, quality compound leads, audit teams, and study teams, to prioritize quality and compliance efforts based on risk assessments.
  • Leverage knowledge of local regulatory requirements, combined with global quality standards, to guide decision-making and direct resources towards areas of greatest risk.
  • Ensure that local teams are aware of and responsive to key risk areas, helping to mitigate potential non-compliance or quality issues.
  • Collaborate with Cross-GxP (Good Practices) quality functions, ensuring alignment across GCP, GMP, GVP, and other regulatory areas in a global context.
  • Act as a conduit between global and local teams, ensuring efficient communication and seamless integration of global quality strategies at the local level.
  • Work closely with regional leadership, study teams, and audit functions to ensure that local nuances are accounted for while maintaining overall quality alignment.
  • Track trial performance and compliance metrics across regions, identifying areas of concern and working with study teams and compound leads to address any deficiencies.
  • Monitor ongoing trial quality at the regional level, ensuring adherence to global protocols while respecting local regulatory requirements and complexities.
  • Provide strategic input to study teams based on performance metrics, helping direct resources and efforts to critical quality issues in real time.
  • Partner with business representatives to assess processes, procedures, and protocols to identify impacts, risks, and interdependencies to build quality into BeiGene RD Operations.
  • Ensure local affiliates are prepared for inspections and audits by supporting them in maintaining global regulatory compliance and readiness.
  • Assist in preparing local teams for health authority inspections by providing guidance on best practices and ensuring alignment with global inspection strategies.
Benefits

As a Quality Assurance Director, you will have access to various benefits, including:

  • A competitive salary ranging from $150,000 to $180,000 per year.
  • Opportunities for career growth and professional development.
  • A dynamic and supportive work environment.
  • A comprehensive benefits package, including health insurance, retirement savings, and paid time off.

Additionally, you will have the opportunity to work with a talented team of professionals who share your passion for quality and excellence.

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