Senior Director, Data Quality and Integrity, Global R&D & PV QA

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 100 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.

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

The Sr. Director, Data Quality and Integrity (Global R&D & PV QA) ensures high standards of data quality and compliance within Global R&D & PV QA. This role leads cross-functional teams to deliver innovative data solutions, integrates AI technologies, and drives process improvements. Collaborating with the Global QMS eCompliance team, the director oversees QA plans, promotes data governance, and engages stakeholders to foster a culture of compliance and accountability in data management practices. The position also involves risk-based validation of IT services and determining audit targets for GxP systems.

Responsibilities
Leadership and Strategic Direction

• The Sr. Director, Data Quality and Integrity is essential in maintaining Daiichi Sankyo's high standards for data quality and integrity.
• This position reports to the Head, Global QMS (RD PV QA) and is a member of the leadership team.
• Lead an enterprise cross-functional QA team to deliver state-of-the-art data-driven solutions.
• Design a fit-for-purpose organization for operational and technical QA oversight.
• Drive innovative process improvements across RD, PV, and Medical Affairs by leveraging emerging technologies and industry best practices.
• Ability to facilitate through proactive and strong leadership; business process excellence to facilitate process simplification and improvement initiatives.
• Ability to implement vision and strategy within the responsible line functions. Set the strategic direction to define best approach for clinical development systems, PV systems and MA systems including data management, statistical programming, digital technologies, and clinical operations.
• Design and implement a fit-for-purpose organization responsible for operational and technical oversight of QA across GxP (GCP/GVL/GCLP/GLP) systems.
• Lead the development of the global Data Integrity strategy and promote a quality culture throughout the Global RD PV QA organization.
• Champion and disseminate educational materials and initiatives related to quality concepts across global teams.Lead and inspire cross-functional QA teams to implement effective data quality and integrity initiatives.
• Develop and implement proactive strategies to address data integrity issues identified during regulatory inspections, such as those from Quality Events, Audits Findings and Regulatory Inspection (FDA/EMS/ PMDA etc.)Guide/advice RD, PV, MA business functions on the creation of Corrective and Preventive Actions (CAPA) to ensure compliance and improve data quality.

Compliance and Quality Oversight

• Play a key role in ensuring compliance with regulatory requirements while driving innovative quality solutions.
• Collaborate with Global QMS eCompliance team to drive harmonization of systems specific to RD, PV, and Medical Affairs.
• Oversee and ensure the deliverables of key stakeholders, including RD, PV, and MA, focusing on establishing and executing QA plans and strategies that promote data integrity and effective data governance.
• Actively engage with stakeholders to cultivate a culture of compliance and accountability in data management practices.
• Ensure that the organization complies fully with all regulations relevant to computerized systems design, build, and implementation.
• Ensure that the organization complies with all applicable regulations related to computerized systems, including GxP (GCP/GVL/GCLP/GLP).Collaborate with the Audits Compliance (RDPVMA) team to determine relevant audit targets for GxP computerized systems and ensure consistent compliance practices.
• Collaborate effectively with IT to align system development with business and regulatory expectations. Review systems for affiliate companies to assess data integrity and implement corrective actions. Manage relationships with stakeholders (RD, PV and MA) to drive timelines and report on key deliverables related to quality and compliance.

Proactive Quality and Risk Management

• Lead initiatives that integrate AI technologies to enhance data quality and integrity, including developing predictive algorithms for fraud detection.
• Utilize advanced data analytics techniques to monitor data integrity and identify anomalies indicating potential compliance issues.
• Determine effective and efficient risk-based approaches for validation and qualification of IT services.
• In collaboration with Audits Compliance team, determine relevant audit targets for GxP computerized systems for consistency.
• A seasoned quality leader with the ability to assess technology and computerized systems fit for business purposes and compliant with regulatory requirements.
• Deploy data analytics and ensure that data investigations stemming from systems used for data collection are properly investigated and that technology-related audits are conducted.
• Oversee and guide quality assurance processes related to project specifications, ensuring standard procedures are followed.
• Deploy a risk-based approach for the validation and qualification of IT services, ensuring that all relevant quality standards are met.
• Proactively assess and address operational gaps related to quality systems and compliance, fostering a culture of sustainable compliance.
• Ensure proper documentation and adherence to quality standards in ongoing projects and processes.
• Coordinate with the Quality Management System (RDPVMA) teams to support the audit functions, including technology-related audits, risk assessments, and inspections, ensuring alignment with overall quality standards and compliance requirements.

Data Analytics and Continuous Improvement:

• Utilize data analytics to monitor and investigate data integrity across systems used for data collection.
• Champion a culture of continuous improvement in data integrity practices, leveraging feedback from audits, industry trends, and technological advancements to enhance data management strategies.

Stakeholder Engagement and Collaboration:

• Facilitate effective communication and collaboration with internal stakeholders, including IT and Compliance Risk Management as well as Global QMS, QMS (GMP-QA).Ensure leadership oversight of GxP (GCP/GVP/GLP/GCLP) projects and CSV requirements, driving timelines and accountability for key quality deliverables.
• Collaborate with internal stakeholders to identify training needs and support initiatives that enhance the skills and capabilities of team members in quality management.
• Foster a culture of continuous learning and professional development within the RD PV QA by sharing best practices and encouraging participation in relevant training programs.
• Provide mentorship and guidance to RD PV QA on quality assurance practices and regulatory compliance.
• Keep abreast of evolving regulations and industry standards concerning data integrity, representing the company in industry forums or regulatory discussions when relevant.
• 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)

Qualifications Education

• Must have a Bachelor's Degree Bachelor's degree in Life Sciences, Pharmacy or Medicines required. An advanced degree such as a Master's degree preferred, PhD or other advanced degree in Life Sciences, Pharmacy or or Medicines preferred.

Basic Qualifications

• Must have 10 or more years of professional experience in Quality, IT compliance and clinical development in the pharmaceutical industry with involvement in regulated clinical trial and / or technical QA activities (i.e., eClincial, Data management).
• Must have at least 7 or more years of professional experience in advance technologies such as AI, data analytics and strong data analysis.
• Must have proven knowledge of global expectations of Health Authorities
• Demonstrated extensive knowledge of ICH- GCP including FDA/EU / PMDA regulations, pharmacovigilance, new drug regulations, other key HA guidance’s, and current industry practice.
• Demonstrated experience of successfully leading an organization or projects of high impact
• Demonstrated leadership and accomplishments in a global/matrix environment
• Must have excellent verbal and written communication skills
• Strong interpersonal and prioritization skills with demonstrated ability to build collaborative relationships
• Excellent problem solving and decision-making skills. Skilled at conflict resolution / negotiation.
• Strong project management skills
• Considerable organization awareness (e.g., interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams across different regions of the world Considerable organization awareness (e.g., interrelationship of departments, business priorities), including significant experience working cross- functionally and in global teams.
• Strong Industry Network in clinical development. Knowledge and understanding of cultural differences and diversity issues.
• Fluency in English (oral and written), other languages a plus but not necessary.

Travel Ability

Must have ability to travel up to 20% both international and domestic.

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.