Director, GCP Quality Operations Inspection Program
Astellas

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and 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 and preparation 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 QA 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 Operations, is a member of the Quality Assurance (QA) Extended Management team and contributes to the development, implementation and successful execution of the QA mission, objectives and 3--5-year strategic plan.

Essential Job Responsibilities:

Strategy Development and Execution

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

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

• As part of inspection readiness, promotes a companywide 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, 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 activities, 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.
• Conducts surveys and captures lessons learned from regulatory agency inspections globally for continuous quality and process improvement.
• Coordinates responses to regulatory agency findings globally and tracks Corrective and Preventive Actions (CAPAs) to completion.
• Coordinates and facilitates the Inspection Administration & Management Network
• Leads cross-functional process improvement activities to improve regulatory compliance and/or improve processes 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, inspection preparation and best practices.
• Support Astellas 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 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 QA personnel for inspection readiness and support activities.

Organizational Context:

• Reports to the Senior Director, Quality Operations.
• Works directly with senior management in M&D as well as non-M&D functions.
• The Director, Quality Operations 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.