Director, GMP QA Technical Operations

Join a Legacy of Innovation 110 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 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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.

Summary

Accountable for setting the overall vision and direction and ensuring all operational goals and objectives are met for the DSI GMP QA Technical Operations Division. The Director is responsible for developing governance and procedures, creating, and implementing plans, working across disciplines to deliver a clear strategy to maintain and improve product quality, and overseeing the divisions performance. The incumbent will provide product, project and GMP SME leadership to direct reports, internal and external stakeholders, across DS entities and product portfolio to attain high quality deliverables. Responsible for GMP activities throughout the product quality lifecycle from clinical trials to commercial launch and post marketing activities.

Responsibilities

- Leadership:

- Establish, lead, and manage robust GMP Technical Operation governance and processes that ensure end-to-end product quality, identify quality improvement opportunities, and optimize productivity for DS IMP and commercial products (e.g., Operational excellence initiatives, GMP SME and technical project, deviation, validation, and analytical service management).

- Develop and manage GMP Technical Operations roles, responsibilities, standards and best practices across multiple IMP and Commercial products and projects.

- Facilitate proactive planning, collaboration and partnership with Pharmaceutical Technology and Supply Chain teams to ensure a continuous supply of high-quality product is available for clinical studies and commercial distribution.

- Champion GMP Technical Operation governance, standards, regulatory requirements, and DS best practices with internal and external stakeholders.

- Support:

- Responsible for establishing scalable business processes and refining existing standards to maximize effectiveness, efficiency and to guarantee best practices in GMP technical Operation activities that support release and distribution of IMP and commercial products.

- Responsible for supporting the development of streamlined processes for QA IMP and Commercial Operations (e.g., Complaint management, product release management, temperature excursion management, stability study management, analytical development, etc) with DSG and external partners.

- Consistently demonstrate sound quality judgement and focus on patient safety and regulatory compliance.

- Identify key product quality issues and risks and present issues and proposed solutions, and make complex quality decisions without compromising safety or compliance

- Drive phase appropriate inspection readiness and compliance activities for QA GMP.

- Represent the company as the GMP Technical Operations SME before US and other regulatory authorities.

- Cross Functional Team Participation:

- Ability to influence decision makers and utilize sound problem solving skills to recommend options and implement effective solutions.

- Provide leadership and subject matter expertise in cross functional teams including interpretation and application of cGMP, Stability and Analytical standards, and applicable Health Authority regulations and guidance for product development, product launches and commercial portfolio.

- People Management:

- Recruit, hire and manage top caliber QA professionals.

- Responsible for creating and sustaining a highly engaged workforce that are efficient at GMP technical operation activities.

- Responsible for timely performance feedback, professional development, and growth opportunities.

- Lead and promote a strong Quality culture aligned with DS values and processes.

- Responsible for ensuring direct reports have completed training on-time and in a manner which meets DS expectations.

- Budget Management: Prepare and adhere to annual budget to manage expense expectations and provide fiduciary oversight to the QA function.

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)

- Bachelor's Degree in scientific discipline required and

- Master's Degree or other advanced degree preferred

Experience Qualifications

- 10 or More Years overall related experience required

- 10 or More Years 10 or more years' experience in an FDA regulated Pharmaceutical Industry with GMP experience preferred

- 10 or More Years • Strong working knowledge of global GxP requirements, Validation principles, Quality Control and Stability methodology, regulations, and guidance; sound judgment and commitment to ethical conduct. • Direct experience with developing strategies and executing tactical plans with cross functional teams in matrixed organizations at all levels. • Direct experience in successfully supporting health authority inspections • Demonstrates proven track record of leadership, communication, and motivation skills with internal and external stakeholders and direct reports. • Clear concise writing skills and good verbal presentation skills. • Solves conflict and addresses workplace issues in professional and collaborative manner. • Proficient in use of e-systems (e.g., QMS platforms, Trackwise, Veeva QualityDocs, Word, Excel, PowerPoint, SharePoint, etc) preferred

- 10 or More Years Previous management experience preferred

Travel

Ability to travel up to 10%

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.