Senior Manager, Clinical QA (Pharmaceuticals)
Purpose & Scope:
- Responsible for the development and maintenance of excellence in Clinical QA activities for Astellas sponsored programs. This position works in partnership with Medical and Development (M&D) and other business units in support of global and local drug development, registration and marketing for assigned Therapeutic Area(s) (TAs) for all stages of drug development.
- Reports to the Senior Director/Director/Associate Director, Clinical QA and contributes to the development, implementation and successful execution of the CRQA mission, objectives and 3-5year strategic plan.
- Collaborates with relevant CRQA members and M&D for alignment with company-wide standards. Supports Clinical QA project and/or non-project activities to ensure that M&D clinical trials (Phase I-IV) are executed in compliance with the international requirements for Good Clinical Practice (GCP) and other relevant (inter)national regulations.
- Responsible for managing, conducting and/or participating in regional/global audits. Manages external QA resources and provides technical expertise to identify and resolve quality issues.
Essential Job Responsibilities:
1. Responsible for the management of regional, cross regional and/or global multiple audit programs. This includes the independently scheduling, strategy definition, planning, conducting and reporting of audits, liaising with customers on audit findings and the follow up thereof. It also incorporates interpretation of findings, providing trending information, root cause analyses and identifying lessons learned for Astellas organization continuous improvement. Lead the proper management and follow up of the findings and improvement areas.
2. May represent Clinical QA as a Global Quality Lead (GQL) for critical, later stage development projects and Therapeutic Areas. Provides support and consultation to other QA functional areas as needed.
3. Responsible for providing unsupervised GCP expert advice to key personnel. This includes and is not limited to:
- Developing training materials and providing GCP training internally and externally to both small and large professional organizations. It also encompasses coaching of CQA colleagues and other functions on QA related processes
- In case of regulatory agency inspections; review of responses from operations before sending to CQA management for their final review and approval
- Interpreting regulatory authorities requirements and advising in the implementation across the Astellas organization
4. Responsible for regulatory inspection preparation at Astellas entities and/or partners across the region and globally. Analyzes the risks, defines the strategy for inspection readiness and manages the roll out of the inspection readiness program across departments and territories ensuring a harmonized approach.
5. Responsible for identifying outsourcing needs, selecting, managing and evaluating 3rd party QA service providers of which audit and/or consultancy activities have been outsourced. This includes providing training, managing financial information and maintaining effective interfaces to ensure that outputs meet the defined expectations in terms of quality, content and timelines.
6. Supports the development, improvement and maintenance of the Astellas Quality System (both M&D) by identifying root causes to non-conformances related to the processes and/or systems, and by addressing observed gaps in these processes and systems. This includes research of the Pharma Market Place / QA organizations, Regulatory developments and Inspectionreports to ensure Astellas meets its strategic objectives in terms of Quality, Business Model and Effectiveness.
7. Manages quality issues related to critical nonconformance?s, suspicion of scientific misconduct and/or potential fraud. Leads proper corrective and preventive actions identification and rolls out and ensures follow up with effectiveness measures.
8. Manages GCP inspections. This includes communication with Regulatory Authorities, Inspection preparation, inspection hosting, support of CAPA generation and monitoring of follow up to ensure that any risk / nonconformance as identified by inspectors/investigators is adequately addressed and mitigated.
9. Develops and manages interfaces with QA departments of service providers, to ensure QA oversight of the service provider and that any risk to Astellas business is being mitigated.
? Annual auditing of approximately 15-30 regional/global audits, depending on complexity
? Functional Service Provider governance support for up to 3 FSP relationships
? Responsible for the development and execution of inspection readiness plans of approximately 1-3/annum for regulatory agency inspections related to MAA / NDA submissions
? Responsible for supporting regulatory agency inspections of GCP activities and ensuring inspection readiness with an average of 3inspections/annum.
? Bachelor?s degree
? Minimum of 5years in pharmaceutical, biotechnology, or related industry
? Minimum of 2years significant experience in Clinical Quality Assurance (except for Japan internal candidates)
? Minimum of 2years project management experience, preferably in a highly matrixed, multicultural global setting, requiring facilitation, negotiation, problem-solving, and conflict resolution skills
? In-depth understanding of GCP requirements for both marketed and investigational products
? Practical experience and understanding of clinical quality assurance as applied throughout the entire pharmaceutical compound/product life cycle
? Effective oral and written communication and presentation skills in English and/or Japanese
? Solid understanding of CRQA processes
? Proficiency in Microsoft Office
? Domestic and international travel at 10-25% as required
? Advanced degree in related disciplines
The preferredlocation for this position is Northbrook (IL), United Stated; Leiden, The Netheralnds; Tokyo, Japan