• Director, Quality Systems Inspection Program

    Astellas PharmaNorthbrook, IL 60065

    Job #1201905188

  • 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, Quality Systems Inspection Program opportunity in Northbrook, IL.

    Purpose & Scope:

    For business continuity and success with the Astellas portfolio, Astellas must maintain compliance with the most current legislation and best practice standards across the lifecycle of their product(s). Permanent GxP/GPvP "Inspection Readiness" is essential for proactive measures to support Astellas products and operations. This role is responsible for the development, implementation, and maintenance of excellence in Inspection Administration. Responsible for developing Inspection readiness strategies, procedures and program management for all global activities related to M&D as well as supporting non-M&D organizations. Ensures global implementation and consistency of processes and procedures with the respective CRQA functional areas. This includes the establishment of regulatory agency inspection and customer audit metrics.

    This leader role ensures the Inspection Administration Program is maintained globally, which includes central oversight over compliance, quality and efficiency from ongoing inspection readiness including but not limited to Clinical site inspections, Sponsor inspections including affiliates, pharmacovigilance inspections, Customer audits of Astellas, metrics reporting for Management Review/Quality Council, and inspection readiness training.

    Reports to the Senior Director, Quality Systems, is a member of the Clinical and Research Quality Assurance (CRQA) Extended Management team and contributes to the development, implementation and successful execution of the CRQA mission, objectives and 3-5 year strategic plan.

    Essential Job Responsibilities:

    Contribute to development and implementation of 1-3 year Quality Systems specific objectives and plans as part of the overall CRQA strategy and plans. Participates with the Senior Director, Quality Systems as a member of the CRQA Extended Management Team in the successful execution of CRQA vision, mission, objectives and plans.

    Leads the successful implementation of annual Quality Systems strategic goals and objectives.

    · As part of inspection readiness, promotes a company wide understanding of the QMS and regulatory compliance requirements. Evaluates inspection findings for needed process improvement.

    · Conducts/Coordinates routine and ad-hoc mock inspections / rehearsals

    · Researches and maintains current knowledge of applicable legal and regulatory developments, industry standards, Astellas business strategies to determine emerging compliance trends and incorporates such developments, standards and trends into education for M&D, as well as inspection readiness and direction to Astellas.

    · Drives regulatory compliance and inspection readiness requirements that build fundamental and sustainable process improvements across Astellas

    · Implements and maintains a consistent process for inspection readiness and management through maintenance of global procedures and core training

    · Leads/Co-Leads Sponsor inspection readiness meetings, works with all impacted Astellas functions to ensure that inspection preparation deliverables are met per required timelines

    · Prepares/provides guidance for Inspection Management Plans that include activities to build inspection readiness into processes

    · Lead/Co-Lead all communications for inspection preparation activites, announcements, ongoing updates

    · Identifies gaps and issues and works with team(s) to develop strategies to mitigate risks during inspections

    · Conducts/Coordinates inspection preparation sessions (mock SME interviews/inspections, training, preparation visits)

    · Track and trend all regulatory inspection and customer audit issues/observations to provide meaningful metrics at Quality Council and for use in ongoing inspection readiness.

    · Leads cross-functional process improvement activities to improve regulatory compliance and/or improve processes in order to promote Astellas in representing best-in-class practices.

    · Participates in industry forums for inspection readiness information exchange and benchmarking

    · Manages multiple projects/processes efficiently at the same time

    · Demonstrates sound and independent judgment, prudence and maturity in dealing with complex and highly confidential business and compliance information

    · Develops and implements strategies for and leads collaboration within Astellas to embed a culture of compliance, accountability and ownership of inspection readiness activities

    Quantitative Dimensions:

    • Support M&D and non-M&D employees by offering consultation, advice, and subject matter expertise on inspection readiness and best practices.
    • Support M&D during at least 20 Regulatory and customer inspections/audits per year.
    • Responsible for ensuring global oversight for all inspections and audits worldwide which includes Sponsor inspections, pharmacovigilance inspections, Clinical site inspections involving Astellas trials and Customer audits. This information is used for maintenance of global inspection and audit metrics.
    • These activities have major significance to the M&D organization, and require in-depth subject matter expertise, strategic thinking and leadership skills to effectively manage complex operations resulting in regulatory controlled deliverables and successful regulatory agency outcomes. Additionally, non-M&D functions, in Scope of an inspection/audit, are also impacted.
    • Responsible for the management of employees and non-employees involved in performing the activities to support the Inspection Readiness Program. This includes mentoring and coordination of CRQA personnel for inspection readiness and support activities.

    Organizational Context:

    • Reports to the Senior Director, Quality Systems.
    • Works directly with senior management in M&D as well as non-M&D functions.
    • The Director, Quality Systems Inspection Administration is responsible for providing support and guidance to all Astellas personnel impacted by an inspection/audit.
    • Has direct and indirect managerial and leadership accountability for M&D compliance activities with support of non-M&D organizations.
    • Mentors and coordinates the day to day operational activities of inspection/audit preparation and support staff.
    • Effectively delegates responsibilities to achieve inspection readiness and effectively develops and aligns individuals to the best of their abilities, while ensuring optimal oversight and supervision.

    Qualifications:

    Required:

    • Bachelor's degree required
    • Minimum of 7 years quality assurance experience in the pharmaceutical industry
    • Demonstrated leadership skills, including the ability to lead and manage projects and staff in a matrixed and global setting
    • Experience in Inspection/Audit preparation of Sponsor and related sites (e.g., clinical sites) within a GCP /GLP/ GPvP environment. Comprehensive knowledge of GxP and other pertinent regulations and understanding of global quality standards relating to product development, submission and/or commercialization.
    • Demonstrated ability to assess the state of current business and QA operations to identify and recommend future state, improvements, and to implement action plans.
    • Demonstrated experience facilitating and leading global process improvement and harmonization activities.
    • Demonstrated competence to resolve complex and diverse problems with decision making responsibility that has a major impact within Quality and/or with functional groups globally.
    • Effective written and oral communication and interpersonal skills, facilitation and influencing skills with an ability to interface globally across multiple departments and across various levels of management with Astellas and with external stakeholders.
    • Able to meet the availability requirements of the position and can travel for domestic and international business needs as required: approximately 20 - 25%.

    Preferred

    • Advanced degree in related disciplines preferred.
    • Preferred location for this position is Northbrook (IL), United States; Leiden, Netherlands; or Tokyo, Japan.

    LI-VB

    Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

    Category Clinical and Research Quality Assurance (CRQA)