PQE is a service provider company, leader in Pharmaceutical and Medical Device sectors since 1998. With a network of over 350 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.
Further information can be found at www.pqegroup.com.
Due to a constant growth, PQE is looking for a new IT Validation Lead in Boston, MA.
- The role of the 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/Infrastructure Qualification standards and practices.
- This is accomplished by:
- Participating in the delivery of system solutions by documenting SDLC/CSV/Qualification activities.
- Developing validation/qualification/migration/verification strategies for software (including lab), data, mobility, hardware, 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).
- 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.
The candidate will work and/or lead in multidisciplinary teams.
- Technical/scientific Bachelor’s degree (preferred Biotechnology, Microbiology, Biology, Pharmaceutical Technologies);
- 5-6 years of IT experience
- Minimum 4 years’ experience in SDLC/CSV/Qualification Lead roles (and/or leading testing teams) on software. development or IT-related projects.
- Participation and/or completion in Testing certification programs (Six Sigma, CQSA (Certified Software Quality Analyst), CSTE (Certified Software Tester) or CSTP (Certified Software Test Professional)).
- Technology and Microsoft knowledge and expertise.
- Customer and service orientation to support interaction with team resources and clients.
- Performance and productivity oriented to drive quality testing outcomes and results within DB Testing practice.
- Previous program and project management experience.
- Proven experience with IT Risk Management and Control policies and procedures.
- Previous experience working effectively in globally diverse teams and matrix organizations
- Demonstrated ability to cooperate with a variety of people and achieve results
Nice to have:
- American Society for Quality (ASQ)
- Certified Software Quality Engineer (CSQE)
- Quality Assurance Institute (QAI)
- Certified Software Test Engineer (CSTE)
- Relational & communication skills
- Project management
- Resource management
- Proven analytical and problem-solving skills
- Prioritization skills
- Strong work ethic
- Fluent English (written and oral)
- Availability to travel domestically and abroad (at least 75%)
Location: Boston, MA