Manager, Quality Management Systems in Basking Ridge, New Jersey at DSI

Date Posted: 11/27/2019

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 Quality Management Systems Manager is responsible for the managing and maintenance of the Quality Management System. This includes day-to-day support, continuous improvement, and ensuring the consistent implementation of global quality system policies.
  • Manages and adheres to Global Quality Management System (QMS) Identifies, triages, escalates and monitors quality issues and investigations across the organization. Elevates serious and/or systemic problems with appropriate recommendations/solutions to Senior Management for immediate and long-term resolution in accordance with Global procedures.
  • Proactive ownership of global Quality System procedures (Standard Operating Procedures and Policies such as Change Control, Deviation, Corrective and Preventive Action, Document Management etc. Responsible for the timely completion global compliance, deviation, and CAPA commitments.
  • Collaborate with local and global Quality teams to ensure adherence and alignment to global policies, processes and practices. Support the implementation of a single harmonized Quality approach across divisions.
  • Responsible for ensuring that the quality management system drives global regulatory compliance, is scalable and appropriate for the organization and product portfolio. Ensures consistency in implementation of global processes, CAPAs, and inspection responses. Manage key quality system projects driving alignment at all levels of the organization
  • Experience with drug development and/or commercial Quality systems focused on the development, manufacture and delivery of small molecule, biologic and advanced (gene) therapy IMP. Leads risk assessment and mitigation activities to establish and improve the Quality Management System. The candidate works cross functionally to align the approach to quality and compliance across the global organization.
  • Expertise in the areas of responsibility with technical and personnel leadership qualities, including GxP acumen aligned with industry best practices. Partners with clinical and/or commercial operations and across organization to streamline and continuously improve Quality systems, ensuring compliance with regulatory requirements.
  • As needed, partner to support audits and inspections with the goal of compliance to regulations and global harmonization. Support identification and implementation of new regulations and Quality trends within the Pharmaceutical industry through literature review, professional conferences, and benchmarking organizations.


Responsibilities:

Program Oversight
  • Responsible for supporting all aspects of the Quality Management System to support standards, procedures and compliance. Local and global responsibility for the day to day management of process effectiveness and where gaps are identified; proactively escalate to Senior Leadership, propose and implement solutions to ensure compliance.
  • Proactive oversight of the Quality System (process, systems and procedures) to facilitate ongoing pharmaceutical development activities for adherence to the current regulations and industry best practices. Champion an environment of transparency and continuous improvement in managing and implementation of Quality Process and Procedures
  • Drive and foster a Quality Mindset across the organization and work with relevant stakeholders to implement a Quality Culture focused on delivery of results as it pertains to focused deliverables within the functions and to the stakeholders

Stakeholder and Cross-functional Support
  • Collaborate with the functional representatives within DSI and globally within the DSG network to align processes and procedures as they pertain to how the organization executes work and ensure alignment with industry regulations and best practices
  • Partner with local and global functions to provide guidance and oversight of specific processes. As part of global support, ensure cross-functional alignment and overall applicability across regions to support process excellence and compliance
  • Ensure GxP principles are applied cross-functionally to support regulatory compliance of on-going activities as they pertain to delivery of organizational objectives and effectiveness
  • Support the management of Deviations, CAPAs, Investigations and non-conformances as required – including development of metrics and reporting tools to support compliance

Audits, Inspections and Compliance
  • Liaise with functional and other Quality teams as appropriate to ensure global and local coverage of inspection readiness activities as they pertain to the Quality Systems. As appropriate act as backroom support for Regulatory Inspections, including document management in accordance with the QMS
  • Demonstrated advanced knowledge in the support audit/inspection programs, and the translation of findings into corrective actions plans that mitigate risks to the organization, patient safety and data integrity. Actively participates in quality related audit/inspection initiatives as necessary
  • Lead and drive Compliance initiatives across the organization to support process excellence

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 Quality Compliance and/or Vendor Management in the pharmaceutical/medical device industry with involvement in regulated clinical trials and / or technical/commercial QA activities (i.e., Clinical Trials/Operations etc).

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.