About OnShore Technology Group

For over 15 years, we have worked as a trusted partner with our clients as well as many global system integrators and technology companies to help deliver turnkey validated systems and ensure sustained compliance.

OnShore’s leading innovation is ValidationMaster™, the first Enterprise Validation Management System (EVMS) of its kind to include a validation Kanban board and seamless integration with our unique ValidationMaster Quality and Risk Management portal.

Sr. Validation Project Manager

LOCATION:

Chicago, Illinois, USA

ABOUT THE POSITION

The Sr. Validation Project Manager shall be responsible for the overall planning and execution of all computer systems validation activities. This responsibility includes, but is not limited to, validation project budgeting, scheduling/resource management and executing activities to meet project deliverables throughout all phases of cloud-based or on-premise computer systems validation programs. The Sr. Validation Project Manager shall work closely with all key stakeholders including program managers, quality assurance and other relevant project teams to facilitate communication, implementation and management of lean validation processes for computer systems.

ROLES & RESPONSIBILITIES

  • Work closely with system integration team members and SMEs to ensure that all validation activities and deliverable are highly coordinated with the broader schedule of all implementation activities.
  • Mitigation of schedule risks by ensuring on-time arrival of inputs and on-time delivery of outputs.
  • Understanding of management/ deployment on cloud platforms and services (AWS/ Azure/ Google etc).
  • Proactively communicate status on progress of scheduled activities to various stakeholders.
  • Manage all validation activities required to comply with current regulations.
  • Facilitates the resolution of software deficiencies that prevent successful completion validation projects.

EDUCATION & CERTIFICATION

  • B.S. or equivalent in computer science, engineering, life sciences, or related field.
  • Minimum 10 years of experience in software quality assurance in the life sciences industry in a leadership role.
  • ASQ CSQE Certification or equivalent preferred.
  • Practical working knowledge of software development and implementation methodologies.
  • Experience with the validation of Enterprise Resource Planning (ERP) systems is preferred.
  • Strong oral and written communication skills in English.
  • Excellent interpersonal skills.
  • Advanced project management, organization, and communication skills.
  • Practical experience in conducting and supporting CSV audits and inspections.
  • Advanced proficiency in the use of Microsoft Office and Microsoft Project desktop applications.

REGULATORY KNOWLEDGE REQUIREMENTS

  • ISPE GAMP 5®
  • U.S. FDA Validation Guidance Document
  • 21 CFR Part 11 Electronic Records; Electronic Signature Final Rule
  • U.S. FDA Data Integrity Guidance
  • NIST Cybersecurity Framework
  • 21 CFR Part 210/211 cGMP
  • EUDRALEX Annex 11 Rules Governing Medicinal Products in the EU, Volume 4
  • 21 CFR 820 Quality System Regulations
  • 21 CFR 820.30 Design Controls
  • Other regulations as applicable

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