Associate Director, R&D Quality Systems, Strategy, and Excellence

hace 2 meses

Alcobendas, España BeiGene A tiempo completo

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.

General Description:  

The Associate Director of R&D Quality Systems, Strategy, and Excellence (International & Affiliate) plays a pivotal role in ensuring the consistent implementation and alignment of global quality policies, procedures, and GxP standards at the local and regional levels. This global position is responsible for supporting local affiliates in building and maintaining robust, efficient, and fit-for-purpose Quality Management Systems (QMS) that comply with global standards while addressing local regulatory nuances. The role involves working across multiple regions to embed Quality by Design (QbD) principles, ensuring that quality is proactively integrated into processes and procedures from the outset to proactively manage quality around the globe.

This role will track and analyze quality and compliance metrics across countries and regions, identifying trends and risks to prioritize quality activities. By partnering with key stakeholders, including cross-GxP functions, Risk-Based Quality Management (RBQM) teams, quality compound leads, and study teams, the role ensures that global quality strategies are effectively operationalized at the local and regional levels. This alignment equips affiliates to meet regulatory requirements while maintaining the flexibility to adapt to local demands. Through collaboration, data-driven insights, and a risk-based approach, this role drives continuous improvement in quality systems and processes, ensuring global compliance across GCP (Good Clinical Practice), GMP (Good Manufacturing Practice), and GVP (Good Pharmacovigilance Practice). Ultimately, the role is pivotal in fostering a culture of quality excellence, ensuring all R&D activities consistently deliver high-quality outcomes worldwide.

Essential Functions of the Job:

Manage and oversee R&D Quality activities which include, but are not limited to:

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 R&D 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.

Additional Qualifications:

Expert knowledge of GCP, FDA, EMA, MHRA and ICH requirements. Bachelor's degree with 8+ years, Master’s degree with 6+ years, or PhD/MD/PharmD with 4+ years of R&D quality assurance experience. Proven experience in leading teams, with a track record of developing and implementing processes and systems in a global context. Ability to resolve complex problems where analysis of situations or data requires an in-depth evaluation. Superb attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment. Exercise sound and balanced judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, plans and protocols for compliance. Proven ability in setting strategy for and driving quality process improvement initiatives. Strong leadership, project management, and mentoring skills. Other duties as assigned

Supervisory Responsibilities:  

This position may include managing staff: coaching and mentoring of junior staff with training/orientation/qualification and development plan for new Quality staff when required.

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity

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