Associate Director, QA Vendor Quality

Join a Legacy of Innovation 110 Years and Counting!

With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 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 hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary:

• Manage and execute GxP Vendor Quality Program, projects/teams with high degree of independence. Deep understanding of GxP vendor programs that support clinical trial delivery for both internal and external impact to support organizational needs and activities
• Create fit for purpose processes that align divisional and global needs of the Vendor Quality programs to ensure functional support within each of the DSG functions for compliance and alignment with regulatory requirements support Phase 1 to Phase IV activities for agility and efficiency
• Lead efforts for global understanding of local/global vendor requirements and work with DSG teams across Europe and Asia including Japan to harmonize and align processes and practices across DSG. Work to simplify processes as applicable and implement fit for purpose work processes that enhance regulatory compliance
• In collaboration with internal vendor functional teams and DSI leadership work closely to address compliance issues related to vendor selection, onboarding, performance to achieve desired organizational and regulatory outcomes
• Act as a change agent to manage and enhance Vendor related activities to support organizational processes at the local and global level. Develop and drive consistent vendor management principles across the different functional groups
• As part of continuous improvement, lead and identify enhancement efforts to support refinement in the operating model including implementation of new regulatory requirements
• Support inspections and inspection readiness to ensure that any compliance issues identified are appropriately addressed – including implementation of long-term solutions to maintain a state of compliance
• Maintain industry collaborations and apply industry best practices to support ongoing vendor and outsourcing activities

Responsibilities:

Program oversight, Quality focus (local/global) and Continuous Improvement

• Champions and adheres to industry and Global Quality Vendor Quality Principles. Identifies, triages, escalates and monitors vendor related quality issues and investigations across the organization. Elevates issues and/or systemic problems with appropriate recommendations/solutions to Senior Management for immediate and long-term resolution in accordance with Global procedures/practices.
• Generate and monitor Key Quality Indicators (KQIs) in accordance with the QMS and Vendor Oversight best practices. Develop, implement, and update Quality Management Documents for Quality Assurance activities that support the GxP Vendor Quality Program.
• Leads process development/global harmonization of vendor related activities to drive efficiencies and compliance to local and global regulations. This included application of new regulations and industry best practices to meet functional needs
• Provide leadership for vendor program management and implementation

Cross-functional/Stakeholder Support

• Provides QA consultancy and appropriate risk analysis to key stakeholders (ie. Clinical trial support) to make critical decisions regarding Vendor selection. Liaise and acts as point of escalation for communications with Vendor QA counterparts, including support of development of Vendor Quality Agreements, as applicable.
• Ensures that clinical development activities conducted by Vendors supporting research activities are conducted in compliance with Good Clinical Practice (GCP), protocol, EU Directives, MHRA Statutory Instruments, International Conference on Harmonization (ICH) and Global Policies and Procedures, as applicable
• Serve as the QA Subject Matter Expert (SME) for Vendor Management Activities. As applicable, develop training materials and/or delivers training related to QA Vendor Management Program. Serves as a Subject Matter Expert on QA SOPs/Procedures for Vendor Qualification Audits, Vendor Quality Issue Investigations, CAPA Management and Risk Management.

Audits, Inspections and Compliance

• Liaise with Vendors and functional departments when appropriate to ensure global coverage to inspection readiness needs for outsourced activities and collaborations. Serve as the backroom support for Regulatory Inspections, as necessary including document management in accordance with the QMS
• Demonstrates advanced knowledge in the support audit/inspection programs, reporting of vendor audits and the translation of findings into corrective actions plans that mitigate risks to the organization and to patient safety and data integrity. Actively participates in quality related Vendor meetings as necessary.
• Demonstrated ability to conduct/support various types of GxP audits including 21 Part 11 Assessments, CSV etc. Experience with supporting Clinical Investigator Audits, Trial Master File Audits, Clinical Study Report Audits, Marketing Application and Database Audits is a plus

Qualifications:

Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:

• Bachelor’s Degree or Masters in Life Sciences, Engineering or Sciences
• At least 5-7 years of experience in Vendor / Supplier Quality and/or Quality Compliance in the pharmaceutical/medical device industry with involvement in vendor assessment, audit and monitoring as it related to regulated clinical trials and / or technical QA activities (i.e., Clinical Trials/Operations).

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.