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 Senior Director, Quality Systems opportunity in Northbrook, IL.
Purpose & Scope:
Responsible for development and maintenance of excellence to ensure compliance globally for the Medical & Development (M&D) Quality Management System (QMS).
Reports to the Head, Quality Operations, 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.
The scope of this position is to manage and provide global quality oversight for all aspects of development, communication, implementation, maintenance and execution of the M&D QMS.
The Group Lead, Quality Systems is responsible for strategic partnerships and collaboration with M&D Senior Management to recommend, propose, adopt, and execute Quality Systems strategies and frameworks to assure M&D compliance with worldwide regulations and guidances. Responsible for the leadership, coordination and strategic support for worldwide regulatory agency inspections in support of successful product filings and approvals. Partners with the M&D organization to monitor organization performance from a Quality perspective, and leads the Management Review process, driving proactive identification of risk, compliance issues and opportunities for improvement, along with the successful adoption and execution of improvement initiatives.
Essential Job Responsibilities:
Strategy Development and Execution
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 Head, Quality Operations and 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.
* Develops, implements and maintains Quality Systems for the M&D organization including the Quality Manual
* Leads strategy, process and training to ensure regulatory authority inspection readiness for M&D As part of inspection readiness, promotes a companywide understanding of the QMS and regulatory compliance requirements. Evaluates inspection findings for needed process improvement
* Interacts with regulatory authorities and manages the facilitation of inspections by regulatory agencies and third parties globally to ensure successful inspectional outcomes
* Informs the senior most leaders in M&D of the status of regulatory agency inspections identifying potential risks immediate mitigation
* Captures lessons learned from all regulatory agency inspections globally for continuous quality and process improvement. Coordinates all responses to regulatory agency findings globally and tracks Corrective and Preventive Actions (CAPAs) to completion.
* Responsible for establishing and managing continuous quality improvements, providing the direction and strategic oversight to the development of quality systems metrics (including key quality indicators) for monitoring the state of compliance of M&D processes including management of external quality/regulatory intelligence.
* Provides leadership and guidance to the functional groups for significant issue management (Deviations/CAPAs). Ensures appropriate implementation of corrective actions and quality system improvements. Leads effective escalation process for management of Deviations/CAPAs, analysis of risk and measuring effectiveness.
* Supports the maintenance and administration of the Astellas document management system (e.g. ADMS, Veeva) globally for M&D. Trains M&D staff globally on Policies, SOPs and accompanying supporting documents that describe processes that support global programs and submissions to regulatory agencies. Ensures Quality Documents are current and reflect/support internal and regulatory agency requirements.
* Responsible for the coordination and follow-up of all Quality Council meetings as part of Management Review.
* Establishes key quality indicators and leads the dissemination of quality metrics to global stakeholders and the review of quality metrics through the Management Review process, driving proactive identification of risk, compliance issues and opportunities for improvement.
* Partners with Business Development globally to identify and evaluate potential and planned M&D outsourcing activities. Assesses business risk from a compliance standpoint in order to support the selection of compliant partnerships and third-party operations. Determines the need for due diligence audits
People & Organization Management
Responsible for the development and effective implementation of optimal Quality Systems organizational structure which maximizes the use of resources globally and reflects business needs and conditions.
Supports an environment to enable each member of Quality Systems to optimally operate in the matrix environment of CRQA and Astellas.
Manages the Quality Systems function and its people, through successful recruitment, performance management, development planning and retention of a high performing team. Effectively delegates responsibilities to achieve Quality Systems goals and effectively develops and aligns individuals to the best of their abilities, while ensuring optimal oversight and supervision to ensure goals are achieved and appropriate growth in technical, leadership and team membership skills.
Responsible for the development and maintenance of effective collaborations with internal CRQA key stakeholders and functions, as well as of relevant external stakeholders:
* Internal stakeholders include all Medical & Development functions to influence and ensure alignment with the requirements of the M&D Quality Management System to drive a consistent and global quality culture
* Liaises directly with regulatory agencies regarding inspections across all GxP areas
* Liaises directly with senior Quality Assurance staff and management of third parties.
* Supports the process for development, training, maintenance and administration of approximately 2,000 Quality Documents supporting the Quality Management System
* Manages the facilitation of approximately 20 regulatory agency and third-party inspections per year including follow-up
* Coordinates and manages follow-up of a minimum of 4 Quality Council meetings per year
* Manages documentation development for several hundred Deviations/CAPAs per year
* Reports directly to the Head, Quality Operations of CRQA
* Has approximately 15 direct reports globally
* Works directly with senior management in all M&D and non-M&D functions
* University 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, global setting
* Experience in managing a Quality System within a GCP /GLP/ Pharmacovigilance environment. Comprehensive knowledge of GxP and other pertinent regulations and understanding of global quality standards relating to product development, submission and/or commercialization.
* Demonstrated experience in hosting and facilitating regulatory agency inspections with successful outcomes.
* Demonstrated ability to assess the state of current business and QA operations to identify and recommend future state, improvements, and to implement action plans.
* Experience in ownership and administration of a document management system.
* 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.
* Demonstrated experience leading strategic development and successful execution of plans and initiatives for addressing complex and diverse Quality matters.
* Able to meet the availability requirements of the position and can travel for business needs as required: approximately 20%.
* Advanced degree in related disciplines preferred.
* Preferred location for this position is Northbrook (IL) United States; Leiden Netherlands; or Tokyo Japan.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled