Associate Director, R&d Quality Systems, Strategy
vor 3 Wochen
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 qu
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