Job Summary

Responsibilities

Strategic Leadership & Oversight and Cross-Functional Team Participation:

• Cross-Functional Team Participation: Develop, lead, participate or manage resources that support various working groups Responsible to contribute to the achievement of global QA vision and enhance globalization at DS QA-GMP affiliates, proactively support and contribute to the development and execution of regional and global QA GMP strategies, internal and external collaboration, activities and initiatives that support and drive compliance and improvement opportunities for IMP, new and established products; Ensure a strong interface with Pharmaceutical Technical Development, CSO, RACMC to ensure full QA visibility and proactive engagement of QA across stakeholder
• Responsible for providing strategic QA GMP leadership and oversight for clinical trial material (CTM) lifecycle management (e.g. supplier and material management, labeling, shelf-life management, packaging, distribution, and destruction) to ensure investigational products are safe, consistent, and traceable.
• Development of Standards and Procedures (SOPs): Liaise with GMP Quality Systems function to ensure adequate procedural documents directly impacting area of responsible and/ or other GMP areas as assigned. May lead and/ or direct key global/regional QA GMP Standards, Procedures and Instructions. Develop, implement, and maintain a global CTM quality assurance program aligned with organizational and regulatory expectations.
• Partner closely with relevant stakeholders across various departments (includes but not limited to clinical supply chain, clinical operations, regulatory, R&D QA, and GMP QA) responsible for various activities in the management of clinical trial materials.
• Establish strong working relationships with Clinical Supplies Organization (CSO) to ensure clinical forecasts reflect shared, achievable targets for QA GMP and align with the broader clinical development plans.
• Serve as the subject matter expert (SME) for CTM quality across regions.
• May represent QA GMP Head in leadership meetings to communicate, deliver and / or execute the vision and strategy of GMP-QA organization. Communicate clearly and in a timely manner with Regional and Global QA organization and local leaders of DS QA-GMP affiliates to address and identify proactive solution for business contribution, ability to effectively manage conflict with diplomacy. Ensure effective influential skills to support the vision and strategy of Global QA mission across boundaries and with different stakeholders.
• Directs and oversees the local process for investigation of commercial and investigational drug product complaints. Assures that all product quality complaints are properly documented and investigated in accordance with GMP and Daiichi Sankyo global and internal SOP requirements. Accountable to ensure adequate resources is in place to manage recall decisions for commercial and investigational drug products. Directs and administers recall operation throughout QA and related functions.

Regulatory Compliance and Inspection Readiness:

• Maintain inspection readiness and lead responses to regulatory inspections and audits for CTM related activities.
• Ensure compliance of clinical labeling with protocol and country-specific requirements.
• Ensure appropriate controls are in place to ensure randomization and blinding integrity.
• Provide QA guidance for clinical protocols, regulatory dossiers and applications (e.g. IND, investigational medicinal product dossiers (IMPDs, Clinical Trial Applications), and clinical inquiries (e.g. Contract Research Organizations, clinical institutions, pharmacies, Medical Affairs, IRB, EC, etc)
• Oversee quality systems related to CTM (deviations, CAPA, change control, risk management).

Responsibilities Continued

Drug Product Release and Oversight of Clinical Trial Materials Lifecycle:

• Drug Product Release: Exercise leadership in order to execute a comprehensive drug product release program for commercial and investigational drug products and assures that all external contractors involved in manufacturing and testing provide GMP compliant release documentation ensuring satisfactory QA review and approval of drug product master production records.
• Ensure proactive planning and forecasting for IMP relevant activities and QA review process as necessary. Support the implementation of related change controls and provide the necessary assessment to ensure that all changes are properly implemented in accordance with regulatory requirements.
• Ensure QA teams are fit for purpose to deliver against projected milestones and on time batch review and release process are in place and as per pre-defined procedure.
• Ensure Stakeholder management and engagement in order to facilitate effective QA engagement across commercial, CMOs and IMP deliverables.
• Responsible for developing a CSO/GMP CTM lifecycle strategy for existing and future global clinical studies to ensure appropriate resourcing and execution.
• Responsible for ensuring CTM activities adhere to GMP and Good Distribution Practice (GDP) from manufacturer to clinical subject per defined clinical timelines and expectations.
• Support Product Release Management activities to ensure CTM disposition (including QP declaration and release) complies with company and regulatory requirements
• Ensure clinical supply planning is shared with QA GMP to ensure disposition activities support clinical development timelines.

Contract Manufacturing Management:

• Contract Manufacturer Organization (CMO) Management: Ensure oversight of outsourced GMP activities provided by contract manufacturing / lab / warehousing organizations and manages the ervices provided by these entities in order to ensure the GMP compliance level expected as per applicable regulation and DS QA Global Standards/ guidelines. Ensures the compliance level for these organizations in order to maintain readiness for regulatory inspections and the compliance with local and global markets.
• Liaises with regulatory agencies and internally on GMP QA issues.
• Work as a cross functional partner to the internal business stakeholders overseeing QA activities for the development of new products or services provided by these organizations.Provide support in the qualification, auditing, and performance management of CMOs, depots, and suppliers associated with CTM activities.
• Ensure third-party compliance with quality agreements and regulatory requirements.
• Responsible for providing quality leadership for E2E clinical inspection readiness activities for CTM
• Oversee and ensure CTM compliance with global regulations (e.g., FDA, EMA, ICH guidelines) as appropriate.

Qualifications

Education Qualifications
Bachelor's Degree in Life Sciences, Pharmacy, Chemistry, or related field is required, An advanced degree (MS, PhD, PharmD) preferred

Experience Qualifications
10 or more years of professional experience in Quality Assurance within biotech or pharmaceutical environments. required 
Strong experience supporting clinical trial materials and clinical supply chains. Demonstrated ability to operate independently and build systems from the ground up. Prior experience working in a matrixed environment is a must. required

Travel Requirements
Ability to travel up to 20% of the time.