Astellas Pharma Director, Quality Systems Management in Northbrook, Illinois
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 Management opportunity in Northbrook, IL.
Position & Scope:
Responsible for the development, implementation, and maintenance of excellence in Quality Management Systems (QMS). Responsible for developing QMS strategies, procedures and program management for all global activities related to the M&D Quality Systems as well as supporting non M&D organizations. Ensures global consistency of processes and procedures and establishment of KPI/metrics. This leader role ensures the Quality Management Systems are maintained globally, which includes central oversight over compliance, quality and efficiency of quality systems including but not limited to internal audits, CAPA program management, metrics reporting for Management Review/Quality Council, and QMS 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:
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 Senior Director, Quality Systems 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 as well as supporting non-M&D organizations with Quality System requirements. This includes close collaboration with GMP QA organizations to coordinate QA activities as well as supporting/aligning with organizations such as Ethics and Compliance, Internal Audit, etc.
- As part of inspection readiness, promotes a company wide understanding of the QMS and regulatory compliance requirements. Evaluates inspection findings for needed process improvement.
- Drives regulatory compliance and inspection readiness requirements across Astellas.
- Responsible for 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 non-M&D organizations utilizing M&D Quality Systems.
- 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.
- 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.
- Responsible for establishing and implementing global procedures supporting the QMS and ensures alignment with the M&D Quality Manual and Corporate Policies.
- Responsible to develop procedures for cross-functional activities in collaboration with global and regional/local stakeholders such as Development Operations, Pharmacovigilance, Regulatory Affairs, and Medical Affairs.
- Leads cross-functional process improvement activities to improve regulatory compliance and/or improve processes in order to ensure that the QMS represents best-in-class practices.
- Establishes tools and ensures appropriate oversight of QMS activities (e.g. dashboards, data analysis tools, business Intelligence tools).
- Support M&D and non-M&D employees by offering consultation, advice, and subject matter expertise on the Quality Management System and best practices.
- Support M&D during at least 10 Regulatory inspections and (Business Partner) Audits, serves as Inspection SME in explaining the QMS including inspection and audit preparation of SMEs.
- Responsible for ensuring global oversight over approximately 20 QMS KPIs, corrective and preventative actions and deviations, a minimum of 5 internal system audits per year, representing CRQA Quality Systems at departmental meetings such as Medical Affairs (monthly meetings), Development (across the functions on a minimum monthly basis), GMP QA (minimum quarterly basis), and the M&D Quality Council (a minimum of 4 times per year), etc.
- 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. Additionally, non-M&D functions, utilizing CRQA Quality Systems services, are also significantly impacted.
- Responsible for the management of approximately 6 employees and non-employees involved in performing the activities to support the QMS (e.g., internal audits, metrics, CAPA Program, Training, etc.).
- Provides oversight of approximately 200+ CAPA documents and investigations per year as well as assisting departments within CRQA (e.g., PVQA, CQA, ESQA) to drive completion of required CAPA documents with their stakeholders
- Reports to the Senior Director, Quality Systems.
- Works directly with senior management in all M&D as well as non-M&D functions.
- The Director, Quality Systems Management is responsible for managing the Quality Systems Management group with staff in all regions. This position has responsibility for approximately 4-8 direct and indirect reports globally.
- 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 QMS compliance staff.
- Manages the Quality Systems Management 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.
- 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 and 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 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.
- 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