Responsible for the leadership and oversight of the following functions within Global Quality Operations; GxP training, GxP risk management and GxP document management services and GxP Systems. Provides strategic leadership and guidance expertise for global and regional quality activities and staff to ensure compliance with global regulations. This role will provide strategic, tactical, and technical/operational guidance regarding GxP (GMP, GLP, GCP) compliance with current pharmaceutical laws and regulations. The incumbent will work closely with the key stakeholders of Global Regulatory Affairs and Quality Assurance to enable and coordinate across global quality activities.
- Develop and implement innovative solutions that will simplify the development and manufacturing of key products and deliverables within the Global Quality teams, identifying inefficiencies, and ensuring those solutions are viable and incorporated as per plan.
- Establish relationships within the broader organization and support projects that will have material impact on our business performance.
- Lead project management activities for special business initiatives across the Global Quality portfolio.
- Oversee change management efforts to support process improvements, updated workflows, and organizational changes.
- Ensure communications between the team, line management and/or senior management are handled in an efficient, effective, and timely manner, to ensure a "no surprises" management environment. Included in this would be oversight of Global Quality Leadership teams.
- Be the point person on the Global Quality budgeting process and actual spend vs. budget.
- Included in the above point person role related to budget is the oversight across all Global Quality pillars at the portfolio level as Finance point of contact for project spend and oversight of pillar management as it relates to purchase order management etc.
- Provides strategic oversight and guidance over Global Quality operations, stakeholder engagement model - technology and information portfolios. Provide feedback, direction, and insight to senior management as needed.
- Establishes regional and global strategic programs for quality as it relates to the health of the quality management system.
- Provides guidance and leadership on planning, execution, and measurement of key quality activities globally with particular focus on Risk Management, GxP Training Document Managed Services and GQ Operations.
- Lead continuous improvement activities e.g., special pilots, prototypes, collaborations, and projects to digitalize the quality management system.
- Maintain a long-term vision of Global Quality to ensure the team is evolving with the changing needs of the business and healthcare landscape.
- Responsible to develop and implement corporate and/or organizational policies and procedures.
- Provide appropriate mentoring and coaching to quality operations with respect to technical skills, business practices, communication and team building to foster a collaborative work environment.
- Develop enterprise-wide solutions across Otsuka that are aligned with the strategic goals of the GQ organization and that lead to measurable business outcomes/results.
- Partner with internal and external stakeholders to understand and drive efficiency across Global Quality's processes and operations via automation and digitization, serving as an enabler of transformation across existing GQ systems, future processes, and teams.
- Provide strategic oversight to bring industry best practices from a variety of disciplines and solutions (i.e., quality, automation, machine learning, and artificial intelligence, etc.) to expand the QMS roadmap that will continue to expand and enhance quality practices and business enablement to a best in class, agile and digital landscape.
- Lead assigned functional groups, departments, and regions to identify opportunities with efficiencies and effectiveness across key areas within QMS, e.g., Observations, Findings, Defects, CAPA's to achieve the goals and objectives of the Global Quality organization and Otsuka to deliver quality products to our patients.
- Interact with the various business groups within the Global Quality team and support each in how to effectively manage items assigned within the QMS to ensure expediency and quality delivery.
- May act as Quality Representative for project information dissemination to internal stakeholders, alliance partners and other company vendors, as applicable.
- Advanced degree required (e.g., MS, MPH, NP, PhD, MD etc.) with a minimum of 10 years of applicable health care, technology or industry is experience strongly preferred.
- credibly, knowledgeably, and effectively. Advanced analytic skills, and general understanding of the drug development and regulatory process,
- Successful track record of leadership and timely delivery of innovative business deliverables.
- Strong communication, interpersonal and alliance management skills; possessing the ability to represent and communicate initiatives to internal and external KOLs/stakeholders, various stakeholders in the medical/healthcare community, Otsuka's partners, and clinical trial personnel credibly, knowledgeably, and effectively.
- Understanding of technological trends and passion to develop innovative solutions that support and enhance medicine, science, and research to increase Otsuka's competitive edge.
- Ability to work effectively in a matrixed, multi-cultural, collaborative, and self-directed environment.
- Strong project management experience, with the ability to successfully engage in multiple initiatives simultaneously.
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.Disclaimer:
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.Valid Proof of COVID-19 Vaccination or Accommodation
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