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Replimune, Inc. Senior Director, Quality Systems in Framingham, Massachusetts

The Senior Director, Quality Systems, is responsible for management of and strategic direction for Replimune’s Quality Systems. This includes the Quality System elements that supports the development, production, testing, and distribution of products covering the spectrum of GLP, GCP, GVP, GMP and GDP. The Senior Director, Quality Systems will lead the organization in establishing, implementing and continuously improving the Quality Systems with agility, effectiveness and efficiency to meet business and quality/compliance objectives.

The Senior Director, Quality Systems, collaborates across Replimune to share, develop, deploy and integrate strategic plans, policies, procedures, Quality Systems performances monitoring to ensure effective implementation and achievement of the Quality Systems

  • This position can be based either in our Framingham or Woburn office

  • Ensure the proper execution for Replimune’s Quality Systems. Ensure that the Quality Systems, including relevant processes and technologies, is established, implemented, and continuously improved while keeping current with emerging and changing regulations, guidance documents and industry best practices and expectations.

  • Develop Roadmap and execute implementation for a consistently compliant, flexible to fit for purpose, effective Quality Systems and associated technologies.

  • Serve as the business owner for Quality Systems technologies and advisor for GxP controlled systems, partnering with business owners, vendors, and IT to support the management the lifecycle of the electronic Quality Systems, including validation, maintenance, and functionality improvements/enhancements.

  • Ensure the proper management of the Quality Systems effectively and efficiently.

  • Own Quality Manual

  • Own Core GxP Training planning. Collaborate cross functionally to ensure execution per plan.

  • Ensure Inspection Readiness for Quality Systems. Support Regulatory inspections as they relate to Quality Systems. Effectively communicate and negotiate with Regulatory Agencies as needed.

  • Mentor, manage and develop Quality Systems personnel. Trains key personnel on quality policies, processes, and SOPs.

  • Establish and drive metrics for Quality Systems including, Documentation, Training, Issue/Deviation, CAPA, Change Control programs, to measure the effectiveness of these programs. Provide data and KPIs to internal organizations to meet Quality Management System requirements for Management Reviews or other ad hoc requests.

  • Provides leadership and partners with QA management team in proactive and strategic planning for QA and translation of the strategy to operating plans for execution

  • Other duties as assigned.

Other responsibilities:

  • Recruit, hire, develop, and retain qualified staff who embrace culture and core values, and increase organizational performance.

  • Manages staff of Quality Systems and ensures the roles are performed effectively.

  • Ensures that all staff are appropriately trained on an ongoing basis and have complete training records.

Educational requirements:

  • A or B.S. degree in an appropriate scientific field.

  • S., Ph.D. or another post-graduate degree is encouraged.

Experience and skill requirement:

  • 12-15 years’ experience in a quality role in a regulated biotechnology or pharmaceutical industry environment, preferably implementing and overseeing QMS for a life sciences organization supporting development programs

  • Previous experience with analytics for use in managing quality systems topics enabling a risk-based approach, is desired

  • Experience with implementation of electronic quality management systems is desired

  • Proven leadership in developing individuals and teams and managing staff to achieve goals through empowering teams.

  • Demonstrated strategic planning and execution skills with a willingness to do hands on work to design/evolve and /or implement quality strategies and operational planning and oversight in a risk based and fit-for-purpose manner enabling effectiveness, flexibility and adaptability in a dynamic and evolving business

  • Knowledge and demonstrated experience in application of risk-based quality principles in a biotechnology and pharmaceutical environment

  • Broad and deep global health regulatory agency knowledge and experience across with current knowledge of industry trends and best practices for efficiency, compliance, and effectiveness.

  • Excellent verbal and written communication skills with demonstrated ability to influence cross-functionally complemented with strong change management experience, adaptability, resourcefulness

  • Operational Excellence experience with proven ability to lead improvement projects is desired

  • This position can be based either in our Framingham or Woburn office

Requisition ID: 2022-1233

External Company Name: Replimune, Inc.

External Company URL: replimune.com

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