Astellas Pharma Associate Director, Global 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 an Associate Director, Global Quality Systems Management opportunity in Northbrook, IL.
Purpose & Scope:
Responsible for the development and maintenance of excellence in the Quality Management System (QMS) supporting Global Regulatory Affairs, Global Pharmacovigilance, Global Development, Global Medical Affairs, and other functions that utilize the Global Medical and Development QMS.
Contributes to the development, implementation, and successful execution of the GCRQA mission, objectives and 3-5 year strategic plan.
This role is responsible for the implementation, execution and administration of the GCRQA Quality System's programs, policies, processes, procedures, and controls in compliance with the evolving global regulatory requirements of the Pharmaceutical industry. Leads a team of Quality professionals that provide expertise and guidance to the business in interpreting and executing against the QMS requirements to ensure compliance.
Essential Job Responsibilities:
- Responsible for implementing new or revised Global Medical and Development QMS requirements. Serves in a leadership role as part of GCRQA. Accountable for integrating process development, improvement and strategy with GCRQA leadership for the QMS.
- Participates in the preparation, management, execution and support of external regulatory agency inspections and customer audits. Maintains a state of inspection readiness through routine monitoring of the global Corrective and Preventive Action (CAPA) system.
- Accountable for efficient performance of the CAPA system, development of CAPA status tracking and trending tools as well as reporting metrics, conducting analyses and using data to identify areas for process improvement as an input to the Management Review process and Quality Council.
- Provides leadership to achieve quality goals, develops and implements an ongoing education program for QMS processes while developing measures to monitor the effectiveness of the QMS itself and drive remediation for improvement.
- Responsible for leadership, development and management of an effective and compliant QMS by working closely with all levels of personnel and management across Astellas functions. Provides quality solutions by participating in business activities and initiatives to promote the awareness of quality.
- Develops internal system audit schedules to ensure QMS requirements are reviewed on a routine basis. Mentors and directs GCRQA auditors, Quality Systems and CAPA staff. Identifies compliance risks and develops sound rationale as basis for the observations.
- Supports effective implementation of the GCRQA organizational structure(s) which maximizes the use of resources globally and that reflects business needs and conditions. Leads and manages global teams. Provides leadership and management to direct reports including day-to-day supervision, performance management, training, and planning while leveraging team member skills and abilities to ensure goals are achieved.
- Responsible for forging strong collaborative relationships with internal GCRQA key stakeholders and functions, as well as external stakeholders.
- Applies knowledge of the Code of Federal Regulations, ICH/GCP (Good Clinical Practice) Guidelines, other applicable regulations, policies, and procedures for oversight and management of QMS requirements.
- Responsible and accountable for the development, implementation and maintenance of GCRQA Quality System's owned procedures and processes.
- Generates Quality Management System metrics and conducts an analysis of these metrics on a monthly basis for all functions and on a quarterly basis for the Quality Council.
- Functions as the GCRQA main point of contact for all functional areas utilizing the GMD Quality Management System locally and globally.
- Supports the GCRQA staff of approximately 70 individuals, by offering consultation, advice, and subject matter expertise regarding QMS requirements and when compliance questions arise.
- Manages the support function/staging room activities during approximately 15 regulatory agency and third party inspections per year including follow-up.
- Manages documentation for several hundred Deviations/CAPAs per year.
- Reports to the Sr. Director, Global Quality Systems Quality Assurance.
- Accountable for the management of approximately 5-10 staff and contract staff.
- Peers include senior management levels in Clinical QA, Electronic Systems QA, and Quality Systems QA and PV QA across the regions comprising GCRQA.
- Collaborates, advises and provides consultation on quality matters to individuals, study/core teams, and Functional Management Teams across the Astellas organization.
- Collaborates directly with GCRQA Leadership Team, GCRQA staff, and various levels within GMD functions including other functions outside of GMD that utilize the GMD Quality Management System.
- Minimum of a Bachelor of Arts/ Bachelor of Science degree.
- Minimum of 7 years quality assurance experience in the pharmaceutical industry
- Minimum of 4 years project management experience, preferably in a multicultural, global setting, requiring facilitation, negotiation, problem-solving, and conflict resolution skills.
- Minimum of 3 years supervisory experience
- Proficiency in Microsoft Office
Skills and competencies:
- Strong interpersonal skills and multi-cultural /intercultural awareness; able to 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 as well as presentation skills.
- Demonstrated 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.
- Strong planning and organizational skills and experience managing multiple priorities simultaneously.
- Strong leadership skills; communicates and demonstrates vision and commitment.
- Domestic and international travel of 10-15% is required.
- Advanced degree preferred.
- Preferred location for this position is Northbrook (IL), United States; Leiden, Netherlands; or Tokyo, Japan.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Clinical and Research Quality Assurance (CRQA)