Associate Director Quality Assurance Audit

About Astellas

At Astellas we are a progressive health partner, delivering value and outcomes where needed.

We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.

We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.

Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.

We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.

Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.

Key Activities are noted below:

• Develops strategy and executes the direction for Clinical Quality Assurance’s approach under the guidance of the Executive Director/Senior Director/Director, Clinical Quality Assurance. In collaboration with the Clinical Quality Assurance Management Team and stakeholders regionally and globally, implements the development of this approach to ensure an effective quality 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.
• Manages, directs and/or provides leadership to Clinical Quality Assurance staff. Responsible for the development, mentoring and support of direct reports and/or appropriate Clinical Quality Assurance resources. Could be responsible and accountable for the Clinical Quality Assurance staff recruitment, development and performance management and organising Clinical Quality Assurance teams for maximum effectiveness
• Continuously evaluates the strategic approach, drives changes in the quality and 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)
• Creates and implements the appropriate strategic risk-based support model
• 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
• Collaborates within Quality Assurance and M&D functions to establish the global audit and oversight program
• Responsible for managing the assigned budget for the Clinical Quality Assurance group as part of the overall Quality Assurance budget.
• Manages and grows the direct reports and Clinical Quality Assurance 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.
• Drives consistency across projects, processes and organization by (not limited to):
• leading process improvement and operational excellence activities across QA and M&D functions.
• supporting and executing Due Diligence and/or post acquisition activities.
• supporting inspection readiness activities
• Enhancing stakeholder relationship to ensure compliance and consistency of regulate activities and associated processes
• Triage of new regulatory requirements, guidance and/or regulations related to GCP and lead the impact analysis to determine if changes in process & quality documents across Quality Assurance and M&D functions are required.
• driving trending and metrics across studies and M&D business processes.
• Responsible for quality oversight to support development programs and submissions by establishing strong collaborative relationships with internal Quality Assurance key stakeholders and M&D functions, as well as of relevant external stakeholders.

Experience and Knowledge:

• Responsible for the development and maintenance of excellence in Clinical Quality Assurance activities for Astellas sponsored programs. This position works in partnership with Medical and Development and other business units in support of global and local drug development, registration and marketing for assigned projects across Therapeutic Area and for all stages of drug development.
• Reports to the Executive Director/Senior Director/Director, Clinical Quality Assurance and contributes to the development, implementation, and successful execution of the Clinical Research Quality Assurance mission, objectives and good years of experience in  strategic plan.
• Under the guidance of the Executive Director/Senior Director/Director, Clinical Quality Assurance, the role will lead Clinical Quality Assurance projects and/or non- project activities to ensure that M&D processes and clinical trials (Phase I-IV) are executed in compliance with the international regulatory requirements for Good Clinical Practice and other relevant (inter)national regulations.
• Mentor within Quality Assurance leading the way for others to follow and demonstrate Quality Assurance’s ability to foster a collaborative
• environment to accomplish common goals within Quality Assurance and across other functional areas.

Qualifications:

• Bachelor’s degree in science.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.