Manager, R&D Quality Assurance NJ

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.   

SUMMARY

• Provide support to the Global and Regional Quality Leads, External Partner Quality Leads, and Business Partner Quality Leads based on assigned programs and in close collaboration with R&D Quality team members to ensure that the organization is in a perpetual state of compliance as follows:
• Support the Global Quality Lead(s) (GQLs) and Regional Quality Leads (RQLs), who are responsible for the delivery and execution of the Global R&D QA strategy, activities, and deliverables against the R&D Oncology and Specialty Medicine strategic priorities, by reviewing and monitoring the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from the internal and external study teams. This may include participation in internal and external cross-functional meetings or other relevant activities.
• Support the External Partner Quality Lead(s) (EPQLs), who are responsible for delivering and executing Quality Oversight aspects of our vendors and partners based on the outsourcing models utilized by DSG, by serving as a back-up to the EPQLs and participating in discussions and activities related to systematic quality-related events specific to the external partner (CRO, co-sponsor, specialty vendor).
• Support the Business Partner Quality Lead(s) (BPQLs), who are responsible for delivering and executing Quality Oversight aspects of our internal (DSG) GQA and R&D business functional stakeholders by collaborating with them in day-to-day activities that include, proactively engaging with relevant stakeholders to drive and shape the quality landscape across regions. This may include assessing regulatory intelligence and industry best practices and sharing with the BPQLs and relevant business partners.
• Support the R&D Quality Operational Excellence activities, which prioritize and focus on the delivery and execution of non-project initiatives within R&D Quality and Global RD/PV QA by collaborating with business process owners on applicable Global QA processes and quality standards for continuous improvement and operations excellence. This may include the review of business partner SOPs and participation in QA initiatives.
• Partner and collaborate with key stakeholders (R&D teams) by proactively identifying risks and potential solutions to ensure that key priority programs are adequately supported and that submission-relevant activities are performed.
• Liaise with the Global Audits and Compliance function to ensure compliance with programs assigned and support the creation of lessons learned from audits and inspections.
• Support investigator meetings and CRO-relevant meetings by reviewing and contributing to the materials utilized to provide quality overview/ training to relevant stakeholders.
• Provide guidance, with oversight by the GQLs, EPQLs, and BPQLs, to internal and external stakeholders of R&D Quality.
• Support the oversight and management of CAPAs by tracking and following up on the status of the CAPAs to ensure adequate CAPAs are defined, implemented, and closed in a timely manner.
• Participate in continuous process improvement activities within QA, as necessary.
• Participate as a Quality Reviewer for Health Authority inspections in the U.S., in collaboration with the Global RD/PV QA team.

RESPONSIBLITIES

• Program oversight: Support the Global Quality Lead(s) (GQLs) and Regional Quality Leads (RQLs) by reviewing and monitoring the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from the internal and external study teams. This may include participation in internal and external cross-functional meetings or other relevant activities.
• Quality by Design (QbD) and Continuous Improvement: Provide support to the BPQLs and GQLs by reviewing and providing input during the development and implementation of Protocol (study level) and Global and Local policies and procedures (system level).Provide guidance, with oversight by RD Quality team members, during the development and execution of Corrective and Preventive Actions (CAPAs) related to GCP audits. Participate in formal investigations of quality events (QEs) as they arise, in collaboration with other QA line functions (Audits and Compliance, QMS, PV/MA Quality).Participate and support lessons learned activities from audits, regulatory authority inspections, and internal process deviations delivered to program teams by assessing the learnings and proposing solutions to address any such gaps and learnings identified. May be assigned to support GSOP activities including the review as appropriate. Other duties may be assigned.
• Cross-functional and Global Team Participation: Collaborate with the assigned BPQLs in support of their collaboration with business process owners on applicable RD processes and quality standards for continuous improvement and operations excellence. Closely cooperate with the Global Audits and Compliance, PV/MA Quality, and QMS to ensure consistency of quality and compliance activities and effective communication. Collaborate with Global QA teams in the United States, Japan, and Europe, as applicable, to gather and generate the data required for the development of relevant quality reports and outputs (JOC, QRB, QQRs, EMR).
• CAPA Management Support the oversight and management of QE-related CAPAs by tracking and following up on the status of the internal and external CAPAs to ensure adequate CAPAs are defined, implemented, and closed in a timely manner.
• Regulatory Inspections: Participate as a Quality Reviewer for Health Authority inspections in the U.S., in collaboration with the Global RD/PV QA team. May be assigned other Inspection Management Team (IMT) roles in support of inspection preparation, facilitation, and post-inspection-related activities under the supervision of the IMT Lead.
• Management Review: Collect the data and information needed to ensure oversight of ongoing review of risks by evaluating Quality Events (QEs), audit, and inspection outcomes so these data may be shared with the relevant business functions teams within the DS organization.
• Risk-based Quality Oversight. Contribute to the measurement of DS KPIs / KQIs to allow for adequate interpretation of risks and trends. Provide interpretation, with oversight by RD Quality team members, of GCP regulations and company process standards, guidelines, policies, and procedures, in close collaboration with RD Quality team members.

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)

• Must have a Bachelor's Degree in scientific discipline, healthcare, or related discipline.
• Master's Degree in scientific discipline, healthcare, or related discipline and/or background in Medical Health Profession (RN, Medical technologist) preferred

Experience Qualifications

• Must have a minimum of 4 years of overall, professional industry experience within Quality (GxP/GCP)
• Solid knowledge & expertise within GxP/GCP environment is required
• Must have experience supporting global projects in both the US and Europe

TRAVEL REQUIRED

Must have the ability to travel up to 20% globally.

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.