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Senior Director Quality Standards & Procedures in Bernards, NJ at DSI

Date Posted: 3/16/2019

Job Snapshot

Job Description

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:

The overall responsibility and core objectives of the Senior /Executive Director quality Standards and Procedures is to provide global leadership, stewardship and set the overall strategy, vision that is forward thinking for the DSG Quality System. The role reports to the VP of Quality DSI / Global Head of RD/PV QA and is critical to business continuity.

Develop, provide effective Governance of the DSG Quality systems which is the foundation of quality and compliance across the DS groups, specifically Global Research and Development as well as Pharmacovigilance. Assure that standards are contemporaneous with external regulatory view and provide the right level of information to assure compliance and reduce the overall risk profile to the company. Assure consistent interpretation and implementation of the standards and associated processes across DS- Groups. Implement a forward thinking strategy to assure new standards are developed to enable new technologies and processes. Proactively engage externally to influence and shape new and existing regulations; management of process owners for all quality systems to ensure end to end implementation. Set strategic direction and ensure that the function (outside of quality) responsible for procedure review has the right level of quality standards to drive procedural changes. Develop a learning platform that enables the cross-functional GRDSOP council and assure governance of all associated quality systems council is managed at the DS group.

Responsibilities:

Quality System Governance and Oversight
Define, set and assure implementation of an overall forward facing strategy and governance process for the DS Quality System.
Lead governance processes, monitor progress, and provide updates on overall status to Sr. Management within Quality.
Define, govern and oversee GxP training programs specific to R&D, CSPV and other areas as applicable to the quality management structure.

Quality Policy and Standards Management
  • Set the overall DSG Quality Standards strategy and implement the quality policy and standard documentation hierarchy. Engage externally to ensure quality policies are appropriately defined and/or updated to include current regulatory thinking and are contemporaneous with industry standards.
  • Assure the quality policies are implemented within the functions through engagement and collaboration.
  • Lead the Development of and reporting on quality standards implementation across all functions.
  • Develop and manage the periodic review and change process for the quality standards.
  • Engage and manage SME engagement associated with the quality policies and standards.
  • Establish and ensure implementation of a process for evaluation and inclusion of internal inspection, audit and compliance findings/ escalation risks into the quality standard process.
  • Deploy an initiative to centralize System for all electronic tools used for procedure development and management across the GxPs, shared drives/ shared point, applications and systems.
  • Lead the case for change initiative by deploying a strategy on how to align, introduce and enhance the standards and procedures in DSG

Process Owner Management
Lead the development and implementation of a process owner program to assure appropriate interpretation and implementation of the DSG quality policies and standards. Assure that the appropriate level of resources; capability and prioritization are given for the processes associated with the quality policies. Engage with key stakeholders to implement the process owner vision and strategy. Assure appropriate process councils are established and appropriately managed, may need to further assess the GRDSOP council and integration of such council into a single line function. Establish and lead DS Quality Standards and Procedure Council which engages and ensure, along with process SMEs, GxP procedures & processes (i.e., SOPs, SOIs) are up to date, robust, aligned, and fit for purpose. Harmonize and standardize processes within Development to avoid conflict of procedures and processes within the functions. Define, govern and oversee procedural document creation/updates, along with the Business Process Owner and SMEs.

Leadership: Quality Engagement
Ensures proactive quality representation at Business development and In- licensing deals, takes a leadership role to ensure quality due diligence of licensing deals and / or acquisitions. Ensures risk assessments and alignment of processes and procedures relevant to deals are met prior to deal closure. Collaborate with other QA functions to ensure vendor oversight and review process of vendor procedures relevant to QA activities are adhered to; ensure quality oversight of vendors during selection process.

Training and Compliance Platform
Establish an appropriate learning platform in collaboration with the relevant functions across the GxP area. Ensure adequate management strategy for Quality. Direct the organization to assure appropriate long term capability associated with technologies necessary for quality management, and that they are are being identified and built into the training programs.

Qualifications

Education and Experience
  • Degree or PhD in Life Sciences, Pharmacy or Medicines
  • Ten (10) plus years of experience in Drug development and the pharmaceutical industry with involvement in regulated GxP activities.
  • Broad understanding of global expectations of Health Authorities
  • Thorough and extensive knowledge of ICH- GCP, GMP, including FDA/EU/PMDA regulations, pharmacovigilance, new drug regulations, other key HA guidance’s, and current industry practice
Competencies
  • Demonstrated leadership and accomplishments in a global/matrix environment
  • Excellent verbal and written communication skills
  • Considerable organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams across different regions of the world

Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All 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.