Principal – QA Validation

About Us

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.

Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people’s development, growth, and the ability to impact patients.

Responsibilities

• Review and approval of deliverables such as validation plans, user requirements, risk assessments, testing scripts, requirements tracing, and validation summary reports.
• Support review and approval of executed protocols.
• Support investigation and remediation of protocol discrepancies.
• Review/Approve Deviations, Change Controls and CAPA(s), and related records.
• Support ongoing maintenance and upgrades to existing systems and utilities.
• Support periodic review of equipment and utilities.
• Support the evaluation of systems for compliance with 21 CFR Part 11 and Annex 11.
• Support site Data Integrity initiatives.
• Support implementation and QA training for new systems (as applicable).
• Mentor personnel within QA and cross functionally to promote compliance and quality culture.
• Support Health Authority Inspections and Client Audits including audit responses and CAPAs.

Requirements

• 8+ years relevant Quality Assurance experience in a pharma/biotech company, working within a Quality System and regulated GMP environment.
• Cell therapy experience a plus.
• 3+ years Validation QA experience.
• Prior experience with implementing quality systems and/or continuous improvement initiatives focused on quality systems.
• Ability to partner cross functionally and integrate feedback during development and implementation of quality systems.
• Ability to work independently to meet objectives and timelines.
• Ability to make decisions of moderate complexity independently and escalate complex decisions as needed.
• Understanding of cGMP and ICH regulations/guidelines.

Benefits

RoslinCT provides a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance.