*** MUST BE ABLE TO WORK ON A W/2 HOURLY BASIS (without Sponsorship) *** NO C2C *** REMOTE / onsite BLEND ***
Our Client is expanding and currently seeks a
VALIDATION COMPLIANCE SPECIALIST
For a 6+month assignment with possible extensions!!
LOCATION: Cambridge, Massachusetts
Position is currently remote, but must report to an office once safe to do so.
(Will report 1 day per week to the office during COVID restrictions)
Leverage your VALIDATION & GxP skills
to help take your career with our Client to
the "Next Level" for 2021 and beyond!
Our Client is seeking a Computer Validation Compliance Specialist to become part their Compliance department. Under the direction of the Head, Data Systems, R&D Quality Assurance and Compliance, you will be responsible for providing support in the QA oversight of Computerized Systems Validation activities related to systems utilized by R&D. The role of DSQA 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:
• Providing 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.
• Be the Subject Matter Expert (SME) on 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 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.
• 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.
• 4 year degree mandatory.
• American Society for Quality (ASQ)
o Certified Software Quality Engineer (CSQE)
• Quality Assurance Institute (QAI)
o Certified Software Test Engineer (CSTE)
• Access to transportation to attend meetings.
• Ability to fly to meetings regionally and globally, if needed.
- There is no per diem with this position
- There is no relocation budgeted for this position. If this position requires you to relocate you will be responsible for those costs.
- MUST be able to work without sponsorship or VISA transfer for this position.
By partnering with Kelly® Technology, you’ll have direct connections to top companies around the globe—giving you the chance to put your tech skills to work on some of today’s most intriguing, innovative, and high-visibility projects. In a world where change is the only constant, our unparalleled connections and IT market expertise help you take your skills exactly where you want to go. We’re here to help you gain experience, keep learning, and move your career forward.
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.