Senior Director, Quality Assurance

1 day ago

Boston MA United States Sumitomo Pharma Full time
Sumitomo Pharma Senior Director, Quality Assurance Boston, Massachusetts Apply Now

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. For more information on SMPA, visit our website here .

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, and direct the functional resources needed to execute this strategy.

Job Duties and Responsibilities

  1. Oversee the development and maintenance of a Quality Management System in full compliance with all regulatory requirements.
  2. Ensure the development of QA systems are effective and in accordance with all government regulations and in compliance with GxPs.
  3. Lead Management Reviews and routine Quality metrics reporting to monitor Quality System performance and identify areas for continuous improvement.
  4. Manage the development and implementation of all necessary GxP related manuals, policies, processes/procedures and work instructions.
  5. Provide guidance and direction on procedures and requirements for meeting applicable regulations and standards.
  6. Provide oversight on eQMS processes associated with deviations, investigations, CAPA, product complaints, risk management, and change control.
  7. Ensure vendor oversight through audits and supplier qualification programs.
  8. Manage an internal audit program for all GxP areas to ensure Inspection Readiness.
  9. Assist in the management of regulatory agency inspections.
  10. Manage personnel in all accountable departments focusing on retention, development, and promoting a Quality culture.
  11. Monitor industry trends and regulatory expectations to ensure evolution of the Quality Management System and compliance strategy.
  12. Develop strategies and operational tactics for quality initiatives.
  13. Other duties as needed.

Key Core Competencies

  1. Bachelor’s degree or related science discipline required; Advanced degree (MS, PhD, MBA) preferred.
  2. 15+ years of experience in the Pharmaceutical/Biopharmaceutical industry with at least 5 years in a leadership role managing quality systems.
  3. Experience in multiple disciplines within Quality (e.g., auditing, investigations, complaints, cGxP oversight).
  4. In-depth knowledge of FDA guidelines and a proven track record in implementing these guidelines.
  5. Significant work experience in a pharmaceutical, cGMP environment is required.
  6. Experience in evolving cGMP related quality systems and improving efficiency of related workflows.
  7. Demonstrated leadership successes in building functions and infrastructure.
  8. Strong ability to analyze complex issues to develop relevant plans and recommendations.
  9. Excellent verbal and written communication skills.
  10. Self-motivated, able to work independently and be reliable and responsive.

The base salary range for this role is $211,900 to $264,900. Total compensation will depend on candidate experience, skills, education, and other factors permitted by law.

Compliance : Achieve and maintain compliance with all applicable regulatory, legal, and operational rules and procedures.

Mental/Physical Requirements : Fast-paced environment handling multiple demands. Requires a high level of initiative and independence.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer.

For more information about EEO and the Law, please visit the following pages:

Equal Employment Opportunity is THE LAW

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