Senior Director, Quality Assurance

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

Job Overview

The Senior Director of Quality Management Systems will oversee the development, implementation and maintenance of the Company’s global GxP quality management system designed to comply with applicable laws and regulations, ensure compliance to the strategy through training and regular management reviews including quality metrics, and direct the functional resources needed to execute this strategy. Directs the development, implementation, and maintenance of quality systems (e.g., vendor management, internal and external audits and inspections, investigations, CAPA, metrics, etc.) and activities. Establishes objectives for the QMS function in line with and in support of company products. Leads the deployment of an electronic QMS to support all Quality related activities including, but not limited to deviations, investigations, metrics and product quality complaints. Partners with internal stakeholders to ensure the eQMS functionally supports cross functional teams and the Company’s processes.

Job Duties and Responsibilities

• Oversee the development and maintenance of a Quality Management System in full compliance with all regulatory requirements.

• Ensure the development of QA systems are effective and in accordance with all government regulations and in compliance with GxPs.

• Lead Management Reviews and routine Quality metrics reporting to monitor Quality System performance and identify areas for continuous improvement.

• Manage the development and implementation of all necessary GxP related manuals, policies, processes/procedures and work instructions.

• Provide guidance and direction on procedures and requirements for meeting applicable regulations and standards.

• Provide oversight, as needed, on eQMS processes associated with deviations, investigations, CAPA, product complaints, risk management and change control as related to manufacturing and other GxP operations.

• Ensure vendor oversight through audits, supplier qualification program and on-going performance management.

• Ensure the organization remains in an Inspection Readiness state by managing an internal audit program for all GxP areas.

• Manages Inspection Readiness activities and play a leadership role in partner audits and regulatory inspections.

• Assist in the management of regulatory agency inspections.

• Manage personnel in all accountable departments with a focus on retention, development and promoting a Quality culture.

• Monitor industry trends and regulatory expectations to ensure evolution of the Quality Management System and compliance strategy.

• Establish and maintain a positive working relationship within the Company and with their external business partners as it relates to area of responsibility.

• Develop strategies and operational tactics for quality initiatives.

• Other duties as needed.

Key Core Competencies

• Bachelor’s degree or related science discipline required; Advanced degree (MS, PhD, MBA) preferred.

• 15+ years of experience working in the Pharmaceutical/Biopharmaceutical industry with at least 5 years in a leadership role managing quality systems.

• Experience in multiple disciplines wi