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location: Cambridge, Massachusetts
job type: Contract
salary: $55 - 64 per hour
work hours: 9 to 5
Under the direction of the Head, Data Systems, R&D Quality Assurance and Compliance, this role is responsible for providing support in the QA oversight of Computerized Systems Validation activities related to systems utilized by R&D. The role of CSQA 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
- 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.
- 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 the company.
- Oversee the validation/verification/qualification strategy development by working with the validation team.
- Work with project teams 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.
- Bachelors degree in a life science or computer science required; Masters degree in management or scientific discipline a plus.
- At least 10 years of pharmaceutical experience.
- Broad experience in computer system life cycle development/computer system validation in R&D.
- Demonstrated experience leading cross functional teams advising on compliance related matters and influencing Senior Leaders.
- Access to transportation to attend meetings.
- Ability to fly to meetings regionally and globally, if needed.
- American Society for Quality (ASQ)
- Certified Software Quality Engineer (CSQE)
- Quality Assurance Institute (QAI)
- Certified Software Test Engineer (CSTE)
skills: Quality Assurance, GLP (Good Laboratory Practice), GCP (Good Clinical Practice), SDLC
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.