Sr. Validation Lead

The Sr. Validation Lead is primarily responsible for oversight of V&V activities for designated computerized system implementation projects. This position requires a senior-level individual with strong experience in supporting computer system validation (CSV) efforts for applications used in GMP, GLP and/or GCP processes ensuring adherence to internal procedures, industry practices such as ISPE GAMP 5, and applicable regulations such as FDA 21 CFR Part 11, EudraLex Annex 11, SOX and cGMPs. 

  • Ability to lead and coordinate multiple CSV projects.
  • Develop/review validation test protocols as required using automated technology tools.
  • Coordinate/communicate with other departments, SMEs.
  • Ensure that all validation deliverables are prepared in accordance with internal guidelines, policies and procedures
  • Create, track and manage all validation project plans.
  • Provide regulatory guidance on principles of CSV to the expanded team.
  • 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 skills at team management, organization, and communication of priorities and listening.
  • Practical experience in conducting and supporting CSV audits and inspections.
  • Advanced proficiency in the use of Microsoft Office desktop applications.

The successful candidate must have a practical working knowledge of the following regulatory 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

Sr. Validation Test Manager

The Validation Test Manager leads a team of Subject Matter Experts (SMEs) in the development, execution, and documentation for cloud and on-premise validated computer systems including but not limited to ERP, CAPA, document management, DHR, plant maintenance, labeling and other quality management systems as required.

  • Management and oversight of end-to-end validation testing program
  • Review test estimates, strategy and approach for IQ/OQ/PQ and Cybersecurity Qualification (CyQ)
  • Development of Validation Test Plans
  • Establish practices that enable culture of continuous improvement and lean validation processes
  • Coordinate volume/stress/load testing activities 
  • Participation in defect (incident)triage meetings
  • Management of automated testing environment
  • Tracking of testing milestones, dependencies, issues, risks and assumptions
  • B.S. or equivelent in computer science, engineering, life sciences or related field.
  • Minimum of 10 years experience in software quality and testing
  • Advanced knowledge of automated testing tools and best practices
  • Experience in testing cloud technologies/platforms 
  • Excellent interpersonal skills
  • Strong oral and written communication skills in English
  • Working knowledge of Microsoft Project and PMBOK project management practices
  • Prior experience/participation in regulatory audits is preferred

The successful candidate must have a practical working knowledge of the following regulatory 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

Sr. Validation Project Manager

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.

  • 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
  • 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.
  • 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