Cambridge, Boston - MA, USA
IT Validation Lead
PQE is a service provider company, leader in Pharmaceutical and Medical Device sectors since 1998. With a network of over 600 dedicated consultants, PQE delivers the highest level of expertise to more than 160 customers worldwide. An international group, PQE operates in over forty countries throughout Europe, Asia and the Americas. PQE offers a worldwide coverage with offices and representatives across Europe, Asia, the Middle East and Latin America, in order to better serve these specific local markets.
Due to a constant growth, PQE is looking for a new IT Validation Lead based in Boston or available to travel/ relocate to Boston for minimum 6 months.
- The role of IT Validation/SDLC Lead provides compliance leadership and direction to business and project teams in Software Development Life Cycle (SDLC)/Computer System Validation (CSV)/Lab Systems/Lab Equipment/ IT Infrastructure Qualification standards and practices. This will be accomplished by:
- Participating in the delivery of system solutions by documenting SDLC/CSV/Qualification activities.
- Developing validation/qualification/migration/verification strategies for complex Information Management Systems, Software (including lab), data, mobility, infrastructure/components and/or business processes prior to release into a live environment per company procedure(s).
- Executing validation/qualification/verification/migration strategies per company procedure(s).
- Conducting High Level Risk Analyses and System Functional Risk Analyses
- Preparing Test Plans and support system verification
- Managing Test Incidents and Deviations
- Supporting System Change Management
- Providing validation/verification/qualification training to stakeholders as necessary.
- Managing relationships with key customers and stakeholders to ensure the total validation/verification/qualification solution delivered to the customer meets/exceeds expectations.
- Working with offshore team/testers.
- Ensuring SDLC/CSV/Qualification activities are conducted in a cost-effective manner.
- Experience with R&D and Quality Management Systems
- Knowledge of GcP and GMP
- Knowledge of Veeva Systems
- Relational & communication skills
- Project management
- Resource management
- Prioritization skills/Time management
- Strong work ethic
- Availability to travel or to accept temporary relocations in US is a must
- US Work permit (green card)
If interested, please send your resume clicking the button on the left of this page.
Our collaborators are engaged, developed, challenged and well-rewarded for performance. We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.