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Astellas Pharma Director, Clinical Quality Assurance in United States

Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture. There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company. Astellas is announcing a Director, Clinical Quality Assurance opportunity in Northbrook, IL.

Purpose & Scope:

Responsible for the development and maintenance of excellence in Clinical QA (CQA) 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 projects across Therapeutic Areas (TAs) and for all stages of drug development.

Reports to the VP/Executive Director/Senior Director, CQA and participates in the development, implementation, and successful execution of the CRQA mission, objectives and 3-5 years strategic plan.

The role will lead CRQA project and/or non-project activities to ensure that strategic leadership and/or operational management are implemented for M&D processes and clinical trials (Phase I-IV) that 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:

  • Develops strategy and executes the direction for CQA's approach in collaboration with the CRQA leadership team / CQA Management Team and relevant M&D stakeholders locally, regionally and globally. Directs the development of this approach and its implementation to ensure an effective quality oversight 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 and directs CQA staff and/or provides leadership, development, mentoring and support for (in)direct reports and/or appropriate CQA resources. May be responsible and accountable for the CQA staff recruitment, development and performance management and organizing CQA teams for maximum effectiveness
  • Continuously evaluates 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)
  • Assures the creation and implementation of the appropriate strategic risk-based support model for assigned project. Represents CQA as a Global Quality Lead (GQL) for M&D clinical projects across Therapeutic Areas. Develops staff to be able to adequately assume the role of GQL to represent CQA on Core and Project teams
  • Ensures the 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 CRQA and M&D functions to establish the global audit and oversight program
  • Provides strategic direction to ensure that the appropriate processes and procedures are in place for C(R)QA
  • Responsible for forecasting and managing the assigned budget for the CQA group as part of the overall CRQA budget
  • Manages and grows the CQA 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 CRQA 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, guidances and/or regulations related to GCP and lead the impact analysis to determine if changes in process & quality documents across CRQA 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 CRQA key stakeholders and M&D functions, as well as of relevant external stakeholders

Quantitative Dimensions:

  • Supports/manages up to 4 CQA resources and/or directly manages 1-5 process improvement initiatives
  • Responsible for a budget up to $1MM
  • Annual auditing of up to 75 audits globally
  • Functional Service Provider (FSP)/Vendor governance support for up to 5 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 5 inspections/annum

Organizational Context:

This position:

  • Reports to the VP/Executive Director/Senior Director, CQA
  • Peers to this position include CRQA Team Leads, global and regional M&D Team Leads and other functions such as Finance, Legal, Internal Audits, Ethics & Compliance, etc.
  • Supports/Manages up to 4 direct reports and/or outsourced support staff excluding administrative assistants
  • Collaborates directly with M&D personnel
  • Direct reports can be located globally

Qualifications:

Required:

  • Bachelor's degree
  • Minimum of 7 years 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 3 years of significant experience in quality assurance
  • Minimum of 3 years 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

Preferred

  • Advanced degree in related disciplines
  • Preferred location for this position is Northbrook (IL) - United States, Leiden - The Netherlands, Tokyo - Japan

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Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled Category Clinical and Research Quality Assurance (CRQA)

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