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
Provide leadership and direction based on assigned programs and in close collaboration with the Head of QA R&D, Americas/Europe to ensure that the organization is in a perpetual state of compliance. This will be accomplished through: •Ensuring strategic support is provided to Global Project Team (GPT) assignments and wherever necessary, takes the lead in ensuring procedural documents relevant to GPT as applicable, to relevant GxPs and capture the right level of regulatory importance.
•Partnering and collaborating with key stakeholders (R&D teams) to ensure that key priority programs are adequately supported and that submission-relevant activities are performed.
•Ensuring end-to-end quality management through proactive compliance based on Clinical Development Plan (CDP).
•Liaising with the Global Audits and Compliance function to ensure compliance with programs assigned and providing lessons learned from audits and inspections to program teams.
•Supporting investigator meetings and CRO-relevant meetings, when necessary, to provide quality overview/ training to relevant stakeholders.
•Providing guidance to development teams in quality and compliance decision-making to drive sustainable and proactive quality.
•Providing leadership and guidance during the development and execution of Corrective and Preventive Actions (CAPAs). Coordinating and reviewing CAPAs to ensure adequate CAPAs are defined, implemented, and closed.
•Led formal investigations of issues as they arise, ensuring timely escalation to line management if critical incidents are not resolved in due course.
•Identifying areas of continuous process improvement and engaging QA teams as necessary as well as key stakeholders. Identifying ways to continuously improve quality and compliance with regulations and company standards, policies, and procedures through a partnership with stakeholders and QA line functions.
•Representing QA in interactions with internal and external contacts and Health Authorities (HA), as appropriate. In collaboration with the Global RD/PV QA team, ensure inspection management by preparing program teams for FDA, EU, and key HA pre-approval and sponsor-monitor inspections; provide inspection management support and follow-up post inspections.
•Providing interpretation of regulations and company process standards, guidelines, policies, and procedures to personnel specifically for assigned programs or for continuous improvement projects.
•Championing, developing, and driving the implementation of study/program-specific quality plans to ensure proactive management of quality.
Responsibilities
– Program oversight:
– Providing strategic leadership closely aligned with business strategy.
– Promoting proactive quality and implementation of quality at the onset of program design into execution. Supporting any necessary vendor-relevant issues identified for the assigned program.
– Ensuring that protocols for assigned programs can be operationalized and address potential risks with key stakeholders.
– Ensuring that quality is represented at key governance teams and taking the lead in instilling the right level of quality across programs assigned within the RD organization. Supporting applicable GCP and Clinical Safety quality and compliance standards/requirements and their implementation.
– Quality by Design (QbD) and Continuous Improvement:
– Providing leadership and guidance during the development and implementation of Protocol (study level) and Global and Local policies and procedures (system level).
– Providing leadership and guidance during the development and execution of Corrective and Preventive Actions (CAPAs) for GCP audits.
– Led formal investigations of quality events (QEs) as they arise, ensuring timely escalation to line management of critical incidences and in collaboration with other QA line functions (Audits and Compliance, QMS, PV/MA Quality).
– Ensuring adequate and effective lessons learned from audits, regulatory authority inspections, and internal process deviations are delivered to program teams.
– Identifying ways to continuously improve quality and compliance with regulations and company standards; policies and procedures through a partnership with internal and external stakeholders; Development Line Functions and Global RD/PV QA.
– Supporting GSOP activities, including the review and signing of deviations as appropriate. Other duties may be assigned.
– Cross-functional and Global Team Participation:
– Collaborating with business process owners on applicable RD processes and quality standards for continuous improvement and operations excellence.
– Closely cooperating with the Global Audits and Compliance, PV/MA Quality, and QMS to ensure consistency of quality and compliance activities and effective communication.
– Collaborating with Global QA teams in the United States, Europe, and Japan, as applicable, to ensure relevant quality reports and outputs (JOC, QRB, QQRs, EMR, etc.) can be delivered and information presented is appropriately represented.
– CAPA Management
– Providing guidance and facilitation during the development and execution of Corrective and Preventive Actions (CAPAs). Ensuring adequate CAPAs are defined, implemented, and closed.
– Regulatory Inspections:
– Facilitating regulatory inspection preparation, management, and follow-up in collaboration with other QA functions and business functions.
– Management Review:
– Ensuring oversight of ongoing review of risks by evaluating Quality Events (QEs), audit, and inspection outcomes and sharing with the relevant business functions teams within the DS organization.
– Risk-based Quality Oversight
– Promoting consistent, transparent, and open communication across both internal and external stakeholders for effective risk-based quality oversight.
– Identifying quality risk and maintaining the DS quality platform by measuring KPI / KQI
– Providing interpretation of GCP regulations and company process standards, guidelines, policies and procedures to relevant personnel.
– Championing the implementation of the study/program-specific quality plan per assigned program. Ensuring full understanding of business priorities and their applicability for adequate quality oversight. Ensuring business objectives are closely aligned with quality deliverables.
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 Life Sciences, Pharmacy or Nursing required and
– Master’s Degree or other advanced degree preferred
Experience Qualifications
– 7 or More Years Quality Assurance experience and involvement in regulated activities or equivalent experience required
– 7 or More Years broad understanding of global expectations of Health Authorities in the management of clinical trials. preferred
– 7 or More Years Thorough and extensive knowledge of international GCP regulations including FDA/EU GCP, ICH, pharmacovigilance, new drug regulations, other key HA guidance’s, and current industry practice preferred
Travel
Ability to travel up to 20%
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.
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