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) (TA) for all stages of drug development.
Reports to the Sr. Director/Director, Clinical QA and contributes to the development, implementation, and successful execution of the CRQA mission, objectives and 3-5year strategic plan.
Under the guidance of the Sr. Director/Director the role will lead Clinical QA project and/or non-project activities to ensure that that M&D clinical trials (Phase I-IV) are executed in compliance with the international regulatory requirements for Good Clinical Practice (GCP) and other relevant (inter)national regulations. Mentor within CRQA leading the way for others to follow and demonstrate CRQA's ability to foster a collaborative environment to accomplish common goals within CRQA and across other functional areas.
Essential Job Responsibilities:
1. Develops strategy and executes the direction for Clinical QA's approach under the guidance of the Sr. Director/Director. In collaboration with the CRQA Management Team and stakeholders regionally and globally, implements the development of this approach to ensure an effective audit program which complies with regulatory requirements and stakeholder expectations. Provides the leadership to drive the development, communication, implementation, maintenance and execution of standards and processes within the function and communicates to relevant stakeholders.
2. Manages and directs the Clinical QA staff and/or provides leadership, development, mentoring and support for direct reports and/or appropriate Clinical QA resources. Could be responsible and accountable for the Clinical QA staff recruitment, development and performance management and organizing CRQA teams for maximum effectiveness.
3. Continuously evaluates the strategic approach, drives changes in the audit program to meet changing needs of the organization, regulatory environment and industry best practices. Manages development and maintenance of the schedules for internal and external audits (e.g. investigator sites and vendors)
4. Creates and implements the appropriate strategic risk-based support model for each project. May represent Clinical QA as a Global Quality Lead (GQL) for critical, later stage development projects and Therapeutic Areas. Develops staff to be able to adequately assume the role of GQL to represent Clinical QA on project teams.
5. Development of short and long-term risk-based quality strategies in support of M&D development programs based on current regulatory interpretations, and drives their implementation locally and globally as appropriate.
6. Collaborates within CRQA and M&D functions to establish the global audit program.
7. Responsible for managing the assigned budget for the Clinical QA group as part of the overall CRQA budget.
8. Manages and grows the Clinical QA resources as appropriate through effective recruitment, performance management, development planning and retention. Delegates responsibilities and empowers team members to achieve goals. Provides optimal oversight and supervision while developing individuals and leveraging their skills and abilities to ensure goals are achieved.
9. Responsible for quality oversight to support development programs and submissions by establishing strong collaborative relationships with internal CRQA key stakeholders and M&D functions, as well as of relevant external stakeholders.
Supports/manages up to 3 Clinical QA resources and/or directly manages 1-5 process improvement initiatives
Responsible for a budget up to $500K
Annual auditing of up to 50 audits globally
Functional Service Provider (FSP) governance support for up to 5 FSP relationships
Responsible for the development and execution of inspection readiness plans of approximately 1-2/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 4inspections/annum.
- Bachelor's degree
- Minimum of 6years working within a regulated environment such as Regulatory, Quality, Pharmacovigilance or Clinical Development or Operations
- Expert knowledge of the pharmaceutical and/or CRO industry, pharmaceutical R&D processes and global regulatory agencies, regulations and procedures
- Proven experience with GCP Quality Management Systems and quality support and oversight of global clinical trials and drug development operations
- Minimum of 2years of significant experience in clinical quality assurance
- Minimum of 2years people/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
- Extensive practical experience and understanding of clinical quality assurance as applied throughout the entire pharmaceutical compound/product life cycle
- Proficiency in Microsoft Office.
- Skills and competencies:
- Effective interpersonal skills and multi-cultural /intercultural awareness; able to negotiate and build consensus for plans and priorities and able to develop effective relationships through collaboration. Demonstrated competence to build strong working relationships with colleagues and stakeholders
- Effective oral and written communication and presentation skills in English and/or Japanese
- Demonstrated ability to proactively predict and resolve complex problems, think strategically and tactically, generate solutions to complex problems and build consensus across the global organization. Able to generate insights and leverage learnings at the individual, team and functional level
- Domestic and international travel at 10-25% as required.
- Advanced degree in related disciplines