Daiichi Sankyo, Inc Hiring for Executive Director, Head of Global RD QA (Global RD/PV QA) job in Basking Ridge Full Time

This position reports to the Vice President, Head RDPV QA Japan/ Head Global RDQA, collaborates effectively with PV Quality pertinent to clinical safety activities needing QA oversight. The incumbent will oversee multiple levels of direct reports (Sr Director, Associate Director, Managers etc.,) across the global RDQA function located in EU, Japan, APAC and Americas. This individual is an extended member of the global RDPV QA leadership team and leadership member of US Corporate Division. The position will be key to represent quality in other cross functional leadership teams such as R&D, CSPV, Medical Affairs, Corporate Compliance and any other LT as assigned. This position will work in close collaboration with Global Head RDPVQA to set the missions and strategy for the R&D organization. The incumbent may also be assigned the other responsibilities for RDPVQA members located in DSI and will collaborate closely with the VP of GMP QA for region Americas shared and aligned QA objectives impacting DSI organization. This position is accountable to drive the standardization and process improvement initiatives across RD Quality and in close collaboration with internal and external stakeholders. This position is accountable to lead, support and set the vision and strategy for the Global RD quality strategy in close collaboration with the business units and in close collaboration with other QA leaders such as VP RDPVQA Japan/APAC, Head, Global PV QA, Head Global QMS, Head of global QA Audit and Compliance and Head Medical Affairs QA. Ensures a fit for purpose global RD QA organization by ensuring that processes and procedures are compliant with applicable GCP/ICH requirements, guidelines, international standards, and company policies. This position will Interface and collaborate with all levels of the organizations, including GMP QA (IMP QA) and QA teams across regions. Maintain knowledge with current industry trends, Health Authority expectations and influence standards accordingly to incorporate into business processes. Define/introduce and implement improvements to existing tools and operationalize new systems in support of overall process excellence in Global QA. This position provides global leadership and strategy across the enterprise in line with the strategic mission and vision of the global quality organization. In collaboration with the Global QMS head, the incumbent will contribute/ lead the refinement of RD QA organization and will partner with business leaders across the organization to define and align on strategic priorities and emerging business changes and trends. The position will lead transformative changes necessary to develop a best in class RD QA global organization of high performance. This position has the accountability to lead strategically, both directly and indirectly where RDQA members reside across the globe (EU, US, Asia, Japan, and other affiliates where QA resides). A strategic thinker, with the capability to interact cross functionally and manage day- to day- operations of the group through leadership and effective interaction / influential skills. Ensures QA staff are engaged, empowered and effective performance management of team. Ability to effectively interact across boundaries (globally and regionally) to engage cross -functional teams within Global Oncology Business unit, Early Development Oncology function, Specialty Medicine, Clinical Operations, Regulatory affairs, CSPV, and other cross functional teams as necessary. Ability to demonstrate effective leadership capabilities in a changing and growing environment. Committed to the values of integrity, accountability, transparency, leadership rigor, and drive necessary for the success of the assigned function. Will be tasked to deputize for VP/Global Head RD QA/ Head RD QA on critical and important business matters. Contribute to the management of global RD QA resource in an efficient and effective manner including but not limited to oversight of defined work products, coaching and mentoring of global team, performance management and contributing to organizational efficiencies.

Responsibilities

Customer Focus:

• Develop a best-in-class Global RD QA organization by refining existing practices, and maintaining the RD quality strategy that supports the interface of RD QA with Audit and Compliance, Medical Affairs, GMP/IMP QA, QMS and Strategy and Operations QA.
• Lead/ Collaborate with cross functional leaders across the company to drive standardization of best practices in the RD area.
• Proactively ensure that all functions consistently operate in a state of compliance. Ensure effective collaboration with RD specifically GDO, Clinical Development, Regulatory Affairs, Precision Medicine/ Companion Dx and Research function.
• Assess / Address redundancies both within QA and in Clinical Operations, specifically where there is overlap in RR between RD QA and GDO quality management team.
• Takes an active leadership role in ensuring that global RD QA expertise is consistently provided to the RD functional area to support the organization in sustaining regulatory compliance.
• Provides guidance to senior leaders in the RD organization on best practices and process related guidance. o Works with teams to investigate and resolve non-compliance, deviations and process related issues.
• Attends relevant senior level meetings where QA input is required e.g. CRO Executive Committee meetings, Ethics and Compliance Meetings at DSI, AOP/APP committee, Development Leadership Meeting (DLT)
• Support all aspects of the Global RD QA quality strategy to ensure successful organization efficiencies, deviation/ Quality Incidence Management/CAPA management and continuous improvement programs.
• Ensures that lessons learned program is in place for critical and inspection trends impacting RD and that the organizational is in perpetual state of compliance.
• Act as management representative for all key health authority inspections (US FDA, EU EMEA, MHRA etc.,), specifically where RD is in question. Develop and maintain an effective working relationship with relevant HAs and other international bodies.
• Ensure end to end compliance cycle SOP-Training- Metrics/Trending- Lessons learned to drive meaningful customer experience across the enterprise for RD QA members globally and for the regional QA team in DSI.
• Oversight: Provide strategic Quality direction pertinent to global RD strategy across the 5ADCs specific to QA processes, procedures and capability of RD QA and it’s interface with global RD business.
• Ability to work with key stakeholders to improve QA effectiveness in areas where interface with QA and RD is determined:•Medical Affairs (Oncology Business unit, Specialty Medicine BU, Japan BU and ASCA BU)•Global Project Teams•Global Clinical Operations team /GDO/BDM/ DDO•Clinical Safety and Pharmacovigilance•Companion Diagnostics/ Device•Vendors/ CROs
• Contribute to Quality Agreement for CRO partners to ensure that the terms of operation with external and RD QA meets company expectations and regulatory requirements.
• Provides support to process development across QA in collaboration with QA Strategy and Operations. Collaborates with Clinical Development functions and other business leaders (i.e.., legal and compliance) to manage process and compliance related issues.
• Ensure adequate inspection management for RD portfolio. Ensure adequate and timely escalation of incidents/issues within business senior management and QA functions.
• Further ensure proper quality oversight and escalation of issues / incidences specifically as it relates to the support functions impacting the QA teams such as 3rd parties/vendors/outsourced activities.
• Serving as a key contributor on several leadership teams and governance committees to provide quality overview, metrics, trends, impacting the Business portfolio: a. DLT b. Quality leadership team c. Develop/chair or co-lead quality council as necessary. d. JOC/ECC committee (external )
• Leadership/ team management:
• Create a high performing team environment and a cohesive culture driven by values of integrity, respect, and culture of speak up
• Lead and hold others accountable to performance, talent, and development objectives
• Create an environment that fosters diversity of thoughts, inclusivity and one that adheres to the principals set forth in the organization (JOIN, GROW, THRIVE)
• Create an environment that thrives on innovation, proactive quality and is disciplined to efficiently execute against pre-defined deliverables
• Drive employee engagement, mentoring, coaching and performance management
• Exhibit servant leadership while driving results.

External Engagement:

• Contribute, help shape the associated external regulatory environment through participation in industry wide activities to assure the needs of the company are proactively established and that innovative approach to solutions are in place.
• Continuously review compliance metrics trends from regulators/ industry experts and align/ develop the RD QA strategic road map to meet changing regulatory and business needs.
• Lead remediations and risk management to assure the organization’s critical systems are periodically reviewed, assessed and continuous process improvement is in place.
• Drive effective relationship with alliance partners, collaborators, vendors, and other key company partners to ensure a culture of compliance at all levels

Strategy:

• Shape the strategic direction of the global RD QA and based on the organization’s mid-term plan and beyond.
• Ensure adequate resource are in place and create a strategy for global RD QA across regions and geographic areas.
• Effectively manage budget on strategic projects as assigned.
• Create and maintain the strategic road map, metrics, dashboard, and project management methodologies to lead an efficient and effective organization.
• Support the global quality annual objectives, strategic initiatives to deliver against the business plan.

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 required
• Master’s Degree or other advanced degree required

Experience Qualifications

• 10 or More Years overall related experience required
• Previous experience at a senior management level leading a QA GCP/ PV / MA QA organization and demonstrated track record of successful results required
• Significant experience in managing many aspects of quality in an international, global context in a regulated health care environment required
• Experience in Pharmaceuticals, Medical Device, Vaccines, Diagnostics, Generics/ Consumer products, required
• Strong expertise in continuous improvement, change management, and evolving the capabilities of an organization preferred
• Experience working directly with global Health Authorities (FDA, EMA, MHRA, CFDA, PMDA, MFDS) and other government and local agencies required
• Working knowledge of the end-to-end Drug development process (manufacturing to commercialization) required