Quality Assurance Specialist, CSV (t337)

  • Contract Duration: 6++ months, REMOTE HYBRID
  • Manufacturing
  • Cambridge, MA

Website Lenox Executive Search


Lenox Executive Search is looking to hire a Quality Assurance Specialist for a contract role with one of our global pharmaceutical clients. Quality oversight is the pharmaceutical realm is a MUST!

Quality Specialist

Objectives of a Quality Assurance Specialist:
• Provides professional expertise, guidance and strong leadership in Computer System Validation and applicable regulatory requirements (21 CFR Part 11/Annex 11/GAMP 5) as applicable to the Global R&D GxP requirements (GLP, GCP, GPvP, GDP) to proactively identify compliance issues/risks in all functions within the organization and its external partners.
• Participating in the delivery of system solutions by overseeing/reviewing SDLC/CSV/Qualification activities.
• Guiding development of 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).
• Overseeing execution of validation/qualification/verification/migration strategies per company procedure(s).
• Providing validation/verification/qualification guidance to stake holders as necessary.
• Managing relationships with key customers and stake holders to ensure oversight that the total validated/verified/qualified solution delivered meets/exceeds expectations.
• Ensuring SDLC/CSV/Qualification activities are conducted in a compliant and timely manner.

Accountabilities of a Quality Assurance Specialist:
• Subject Matter Expert on Company’s SDLC/Qualification procedures and regulations and able to provide guidance to IT and/or Business.
• Participate on cross functional teams to oversee validation/verification, implementation, and maintain regulated (Example: GxP, JSOX etc.) systems across Company.
• Oversee the validation/verification/qualification strategy development by working with the validation team.
• Work with project team’s offshore testers and ensures they develop appropriate test scripts based on the projects User and/or Functional requirements.
• Ensure the project testing scope is met per specified agreement and/or scope change.
• Understands the various testing activities: Unit, System, Component, User Acceptance, Performance, Integration and Regression.
• Thoroughly understands the difference between Positive versus Negative Testing.
• Insure all SDLC deliverables are completed and stored appropriately.
• Leads resolution efforts when issues are identified and escalate appropriately.
• Actively share emerging industry standards/trends with customers and peers within area of responsibility.
• Guide the response and remediation of corrective actions and internal audits.
• Cultivate and maintain contact with key customers, including IT and/or Business; working closely with vendors to complete required tasks.
• Proactively identify and assist in prioritizing opportunities to streamline validation and or qualification efforts but still stay compliant.

Education and Skills of a Quality Assurance Specialist:
-Bachelor’s degree in a life science or computer science; Master’s degree in management or scientific discipline a plus.

– Quality, R&D role, GxP systems
– Quality oversight in the pharmaceutical realm is needed!!!
– Global systems support
– Software development lifecycle knowledge helpful
– Working in Agile environment
– Infrastructure qualifications, systems validation and implementation knowledge
– Lab equipment oversight, computerized systems overview

Licenses/ Certifications of a Quality Assurance Specialist:

• American Society for Quality (ASQ)
o Certified Software Quality Engineer (CSQE)
• Quality Assurance Institute (QAI)
o Certified Software Test Engineer (CSTE)

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– The Lenox Executive Search Team