Astellas Pharma Quality Management Manager 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 Quality Management Manager opportunity in Northbrook, IL.
Purpose & Scope:
Responsible for the development and maintenance of excellence in activities supporting CRQA effectiveness and efficiency, by assisting in developing and maintaining tools and templates, scheduling and reporting CRQA activities, measuring CRQA progress and output, supporting CRQA staff in Inspection readiness activities and management of Regulatory Agency Inspections.
Reports to the Director Quality Management, is a member of the Quality Management team and contributes to the development, implementation, and successful execution of the CRQA mission, objectives and 3-5 year strategic plan.
The role supports and occasionally leads selected projects or activities (as listed below) to ensure that CRQA processes are effective and efficient, state-of-the-art, standardized and transparent to functional customers.
Essential Job Responsibilities:
- Assists in managing the global electronic audit tracking system (e.g., TAMA), including user access, trouble shooting, Change Management, validation testing and creation of reports for the generation of metrics.
- Ensures CRQA training compliance by creating and aligning SOP-role matrices, coordination of new training assignments, collecting and monitoring training compliance metrics, and reporting training compliance metrics to CRQA management (Key contact role)
- Organizes and maintains CRQA collective knowledge by design and maintenance of a common knowledge sharing location (such as SPS) and manages content and user access.
- Provides logistic support for Regulatory Agency inspections and assists in managing these inspections. Maintains the Regulatory Agency inspection overview for Medical and Development. Acts as a back-up for distribution of Inspection announcements.
- Acts as a backup for other roles in the CRQA Quality Management and Quality Operations team.
- Assists in development and implementation of tools, processes and methodologies to monitor progress against CRQA objectives and strategies and develops methods to gather and collate information for status reports to CRQA Senior Management.
- Supports and occasionally leads the implementation of assigned CRQA and QA Operations strategies and process improvement projects which contribute to CRQA compliance, efficiency and effectiveness.
- Supports creation of the CRQA Global Annual Audit Schedule (GAAS) and regular status update reporting; interacts with the CRQA functional units to obtain the necessary inputs in a timely manner.
- Manages CRQA-tools (such as audit report distribution list, audit reference list) to ensure consistency in CRQA activities.
- Provides operational support for CRQA process and compliance improvement initiatives *
- Supports approximately 90 people in CRQA
- Supports monthly and quarterly reporting of CRQA activities globally
- Supports 3-5 and leads 1-2 Quality Management activities
- Responsible for logistic support of 1-2 GxP Regulatory Agency Inspections per annum
- Reports to the Director Quality Management.
- Peers include (Sr) QA managers and Associate Directors in Quality Systems, Technology and Data QA, Research QA, Pharmacovigilance QA and Clinical QA functions of CRQA. Collaborates directly with CRQA management.
- Bachelor Degree required (Life Science preferred)
- Minimum 3 years of experience in pharmaceutical, biotechnology, or related industry.
- Minimum of 2 years significant experience in a Quality organization and/or minimum of 2 years project management experience, preferably in a highly matrixed, multicultural global setting, requiring facilitation, negotiation, problem-solving, and conflict resolution skills.
- Strong understanding of GxP regulations for both marketed and investigational products, and excellent knowledge of global health authorities
- Proficiency in Microsoft Office, Access and Project.
- Affinity with IT systems
Skills and competencies:
- Strong interpersonal skills and multi-cultural /intercultural awareness; able to solicit for input, negotiate and build consensus for plans and priorities and able to develop effective relationships through collaboration. Forges strong working relationships with all colleagues and stakeholders.
- Excellent oral and written communication and presentation skills in English.
- Strong planning and organizational skills and experience in managing multiple priorities simultaneously.
- 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 5-10% is required.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled Category Clinical and Research Quality Assurance (CRQA)
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