Director, Global eQMS Management GMP QA job in Basking Ridge
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New Jersey (NJ),
Basking Ridge
| Job Code: | J3S6586KTVYS5WY1FV1 |
| Employer: | Daiichi Sankyo, Inc. |
| Category: | QA |
| Job Type: | Full Time |
| Location | |
| Country: | United States |
| State: | New Jersey (NJ) |
| City: | Basking Ridge |
| Post Date: | 04/19/2024 |
| Description | |
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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 100 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. 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 Director, Global eQMS Management QA GMP, reports to the Senior Director, Strategic GMP QA Operations. This individual is a member of the governance team for our electronic Quality Management System (eQMS) that is used globally for GxP quality management including GMP and GDP activities performed by DS manufacturing sites, Quality offices and external organizations such as CDMOs and CTOs. This position is responsible to manage, enhance, and expand the eQMS with focus on GMP/GDP activities, supporting the eQMS Business Owner (GMP) into the deployment and maintenance of globalized processes. This individual is part of DSI GMP QA organization playing an important function into Global GMP QA activities and will also serve as a delegate to represent GMP QA in other cross-functional leadership teams such as global RD/PV-QA, Global QA, Global IT, manufacturing sites and marketing authorizations holders across the organization supporting funding and enhancement for strategic expansion initiatives, training and user communication to ensure harmonization and data collection/metrics. Responsibilities - eQMS Oversight: Oversee the management and ongoing enhancement of the eQMS, ensuring its effectiveness and compliance across GxP areas with focus into GMP/GDP - commercial and investigational medicine products, including support for GLP, GCP, PV Cross-functional activities. Manage the eQMS resources including monitoring system performance metrics organization-wide and driving improvements in organizational efficiency. - Global Process Development and Harmonization: Collaborate with the Business Process Owners for the design, development and maintenance of global processes to harmonize, standardize and improve quality processes across DSG affiliates and GMP activities. This includes, but not limited to: - CAPA - Quality Event including Deviation - Change Control - Product Quality Complaint - Product Recall - Audit/Inspection - Vendor/Supplier Quality Management - Analytics and Quality Scorecards - Cross-Functional Collaboration: Act as a representative for GMP users, effectively collaborating with stakeholders managing eQMS from different quality domains. Engage in cross-functional collaborations to ensure the eQMS aligns with the evolving needs of the organization and regulatory requirements. Drive collaboration, alignment and awareness across Global Quality and GMP related functions (Supply Chain, Regulatory Affairs, CMC, Pharmaceutical Technology) who are either direct or downstream users/consumers of the related QMS Systems. Master Data Management: Oversight the establishment and maintenance of core master data sets to be established to support pharmaceutical lifecycle from development to commercialization partnering with related functions to ensure a building in model to support all eQMS systems and evolving Global GMP capabilities and awareness for data management and records retention. - Strategic Planning and Expansion: Support the eQMS Business Owner in strategic planning to ensure system expansion and budgetary decisions, system upgrades, and implementation of best practices in deep collaboration with main stakeholders. - Training and User Communication: Facilitate training and knowledge-sharing sessions to enhance user understanding and engagement with the eQMS. Lead proactive user communication and change management approaches supporting the implementation of system changes and deployment. - Fostering Quality Culture: Foster a quality culture and mindset where a robust and reliable Quality Management System is jointly maintained with all Business Process Owners, driven by continual improvement and consistently applied across business functions in alignment with Health Authorities expectation. 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 Life Sciences, Computer Science, Engineering, Pharmacy or other related area required - Master's Degree Life Sciences, Computer Science, Engineering, Pharmacy or other related area preferred Experience Qualifications - 10+ years of related, professional experience or experience relative to education - 7+ years of experience in quality management within the pharmaceutical industry, with a strong focus on GMP/GDP practices and GxP validated systems required and - Must have proven experience in managing and optimizing an electronic Quality Management System application such as TrackWise Digital, that serves users in multiple geographic locations and functions required and - Must have excellent understanding of global quality standards and regulatory requirements in the pharmaceutical industry. Experience in liaising between business and IT function to translate business needs into IT solutions and technical jargons into business language. - Must have demonstrated experience in global quality process harmonization and standardization initiatives. Travel Ability to travel up to 10% Might be required for on site visits, training or periodical discussions. 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. | |
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