Associate Director, R&D Quality Systems, Strategy, and Excellence
vor 3 Wochen
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.
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 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 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.
- 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.
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
We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
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Basel, Schweiz BeiGene, Ltd. VollzeitAssociate Director, R&D Quality Systems, Strategy, and Excellence (International & Affiliate) 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...
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Basel, Schweiz BeiGene VollzeitBeiGene 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...
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