Quality Assurance Specialist III

Title: Quality Assurance Specialist III

Location: Cambridge, MA but okay to start remote

Duration: 06 Months+

Local candidates needed
On-Site - 1 day per week
6 months contract to start, possibility of extension

Notes from Spotlight Call
- Quality, R&D role, GxP systems
- Quality oversight 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
- Not a validation lead role, but validation experience very helpful
- Will be onsite 1 hr/week during COVID

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 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
• 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 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
• 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 Product is met per specified agreement and/or Product 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, Behavioural Competencies And Skills:
• Bachelor’s degree in a life science or computer science required; Master’s 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.

Licenses/Certifications: Desired:
• American Society for Quality (ASQ)
o Certified Software Quality Engineer (CSQE)
• Quality Assurance Institute (QAI)
o Certified Software Test Engineer (CSTE)

Physical Demands:
Travel Requirements :
• Access to transportation to attend meetings.
• Ability to fly to meetings regionally and globally, if needed.

Salary Range
$55,000.00 - 88,000.00
per Year
Salary range estimated by
Cambridge, MA 02139, US
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