What are the responsibilities and job description for the Associate Director, GMP QA Process Excellence position at Daiichi Sankyo, Inc.?
Join a Legacy of Innovation 125 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
JOB SUMMARY
- The Associate Director, GMP QA Process Excellence is accountable to collect information, analyze quality related process, define strategies to lead to the development and implementation of quality improvement initiatives across the organization.
- This role will focus on driving operational efficiency, ensuring compliance with industry standards, and fostering a culture of continuous improvement.
- This position has a strategic responsibility to drive the maturity of GMP organization working closely with local, regional and global stakeholders across the Quality Assurance organization and with members from different business functions and affiliates to ensure the deployment of operational strategies, global projects and initiatives, focusing on enhancing processes efficiency, culture permeation and team capabilities.
- The incumbent will bring a combination of technical expertise, influential skills, and a passion for process optimization to deliver measurable results through the engagement in design and develop methodologies, pursuing the implementation of projects and monitoring the implemented measures deploying appropriate metrics and assessing initiatives periodically to ensure the reduction of risks associated and accelerating the penetration of an excellence and quality culture across the organization.
RESPONSIBILITIES
Process Excellence:
- Accountable to develop and execute strategies to enhance quality processes and systems organization-wide. Identify and implement best practices for process improvement and standardization. Lead cross-functional teams in the analysis and redesign of business processes. Ensure compliance with regulatory standards (e.g., ICH, FDA, or other industry-specific requirements). Conduct regular assessments to evaluate process performance and adherence.
Change Management
- Act as change agent to promote a culture of continuous improvement and quality awareness. Design, deliver and implement training programs worldwide to enhance employee engagement in quality initiatives. Collaborate with a diverse group of stakeholders to ensure alignment of process improvements with organizational goals.
Data Analysis and Reporting
- Utilize data-driven approaches to identify process inefficiencies and areas for improvement. Develop and perform assessments when necessary to evaluate the data collected and provide meaningful insights to the deployment of future strategies. Establish key performance indicators (KPIs) and track progress toward quality objectives. Prepare and present reports to senior leadership on quality performance and improvement outcomes. Develop tools, deliverable formats and methodologies for process improvement, management of compliance requirements and effectiveness check review to ensure the local and global adherence to the processes defined.
Team Development
- Mentor and guide team members in quality methodologies, such as Six Sigma, Lean, and Kaizen. Foster a collaborative environment to encourage innovation and problem-solving. Support the development of global initiative trainings to ensure the increase of skills rolling out the model to support the growth of the organization and the accommodation to the business strategies aligned with mid- and long-term plans.
QUALIFICATIONS
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
Education Qualifications (from an accredited college or university)
- A Bachelor's degree in a scientific discipline is required
- A Master's Degree preferred
Experience Qualifications
- Must have 7 years of professional industry experience in pharmaceutical operation including first-hand knowledge of drug manufacturing, packaging, QA, compliance, and audit
- Must have a proven track record of implementing large-scale process improvement initiatives, including cultural initiatives
- Direct experience dealing with multinational drug regulators, previous management experience and experience with various pharmaceutical dosage forms highly preferred
Travel Ability
- Up to 10% both domestic and international
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
