Senior Director, Head of PV Quality (US/Europe) in Basking Ridge (Onsite) at Daiichi Sankyo

Job Description

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 120 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. 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

The Senior Director, Head Global PV Quality (DSI/DSE) reports to the Global Head RDPVQA, and oversees multiple levels of direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global PV Quality teams located in Europe and the Americas. This individual is a member of the DSI QA leadership team and extended member of the global RD/PV QA leadership team. This position is accountable to drive a proactive approach to quality and instilling a shared passion for building a stronger Quality organization with One Quality voice as the best trusted quality partner with internal and external stakeholders.

The incumbent must aim to instill a consistent quality mindset and culture through partnering with stakeholders to streamline the product lifecycle process and develop risk mitigation strategies. Provide quality oversight and strategic quality advice to the CSPV and key business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements are in place for quality oversight of marketed products in collaboration with internal QA stakeholders such as GMP QA, specifically for GDP requirements, risk-based assessment for Distributors, co-partners, and affiliates.

Liaise with Audit and Compliance team to ensure that GVP audits are planned, communicated and that audit targets for tactical and strategic GVP audits are in place. Review risk assessment documents stemming from audit outcome to increase compliance within CSPV function. Improve QA engagement with CSPV at the global, regional, and local level pertinent to metrics, lessons learned and improved processes.

Provide end to end safety consultation impacting products from a quality perspective. Provide updates to management on MTP strategy for PV QA area and propose improved objectives as necessary. Deliver methods for risk areas/process improvement to stakeholders via the QMS scheme (i.e., Quality Management Review, Quality Review Board) across the global CSPV organization leaders and relevant external stakeholders.

The role will manage Global PV Quality resources (Americas, Europe: UK, France, Germany and collaborate with members of the team across the globe) 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

• Provide CSPV quality oversight of the Oncology and Specialty Medicine portfolios, in alignment with the business strategy.
• Lead the PV inspection management activities by ensuring readiness, compliance, and inspection preparedness for the respective PV inspections in alignment with regulatory and company strategy.
• Act as the management representative for all key health authority inspections (US FDA, EU EMEA, MHRA etc.,).
• Develop and maintain an effective working relationship with US FDA and other international bodies.
• Support the global quality annual objectives, strategic initiatives to deliver against the business plan.
• In close collaboration with PV QA head for Japan/ APAC, create APAC and China PV QA strategy in close collaboration with the VP, Global head of Quality Assurance (RD/PV QA).

CAPAs

• Ensure adequate CAPAs are defined, implemented, and closed through providing guidance and facilitation of quality event with resolution.
• Proactively ensure that all functions consistently operate in a state of compliance.
• Facilitate the implementation of the quality strategy in close alignment with the CSPV and Medical Affairs business strategy.
• Monitor and track implementation and break-down of the Quality Manual into an annual Quality Plan together with the supported CSPV teams, including the quality risk assessments and inspection readiness components for the designated programs.
• Ensure proactive representation of Quality professionals at strategic non-project team and at CSPV strategic discussions.
• Take the lead as the Head of PV QA with Quality Reviews of respective product profile to ensure appropriate management review of all quality and compliance related topics including the review of Key Quality Indicators (KQIs).
• Collaborate with Global QA teams in Tokyo, Europe and Brazil to ensure relevant quality reports QQRs and or assigned by VP Global Quality Assurance (RD/PVQA) delivered in a timely manner.
• Ensure that safety risks are duly identified, mitigated in collaboration with the business functions. Identify appropriate continuous improvement initiatives for quality and compliance related areas.

Oversight

• Provide strategic direction pertinent to CSPV Medical Affairs activities for internal QA team (global/ local), and not limited to: Global Project Team, Safety Management Team, Clinical Safety and Pharmacovigilance Medical Affairs, Companion Diagnostics/ Device Laboratories Vendors/ CROs

Leadership/ Team Management

• Create a high performing team environment and a cohesive culture driven by values of integrity, respect, and culture of speak up with non compliance
• 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.
• Collaborate with internal and external stakeholders
• Interact with senior CSPV/ Medical Affairs leadership teams to ensure Quality is consistently and proactively represented at program level and along the GvP modules in support of a proactive quality risk management process.
• Interact with the audit and compliance function for the development of the GVP Master Audit Schedule pertinent to PV area. Partners with the respective CSPV groups, CROs, Affiliates in order to ensure high data quality and proactive detection and resolution of issues.
• Provide leaderships with risks tool assessments for PV audits.
• Ensure a fit for purpose PV QA team members whereby new team members are concentrated, as well as establish collaborative relationship with EU QPPV as necessary.

External Engagement

• Continuously review compliance metrics trends from regulators/ industry experts and align develop the CSPV road map to meet changing regulatory and business needs.
• Assure a closed loop of PV risks identified through audits, inspections, internal meetings, remediations and risk management in close collaboration with the organization’s quality management system, to assure robust knowledge transfer and continuous process improvement in both Medical Affairs and CSPV functions.
• Drive effective relationship with alliance partners, collaborators, vendors, and other key company partners to ensure a culture of compliance at all levels.
• Influence change to drive continuous process improvement with stakeholders
   

Strategy

• Support Global PVMQA Head to shape the strategic direction of the global PV QA function based on the organization’s mid-term plan and beyond.
• Ensure adequate PV quality resource are in place and create a strategy for global PV QA within USA/Europe and geographic areas.
• 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 in scientific, health care, or related discipline; and/ or background in Medical Health Profession (RN, Medical technologist, etc.) required
- Master's Degree in scientific, health care, or related discipline; and/ or background in Medical Health Profession (RN, Medical technologist, etc.) preferred

Experience Qualifications

- 10+ years of previous experience at senior management level leading quality organization and demonstrated track record of successful results or equivalent experience required
- 10+ years of significant experience in managing many aspects of quality in an international, global context in a regulated healthcare environment required
- 10+years of experience in Pharmaceuticals, Medical Devices, Vaccines, Diagnostics, Generics/ Consumer products required
- 10+years of experience working directly with global Health Authorities (FDA, EMA, MHRA) and other government and local agencies required
- 10+years of working knowledge of the end-to-end Drug development process in the R&D space required
- 10+ years of Strong therapeutic experience specifically Oncology and all other therapeutic experiences preferred

Travel

Ability to travel up to 20% Local and International Business Travel

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.