Principal – QA Validation

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.

The Principal, QA - Validation is responsible for providing QA oversight of validation activities in support of facilities and equipment validation activities. This includes supporting review and approval of new validation deliverables, governing procedures and training content, as well as supporting maintenance and optimization of facilities and equipment. The ideal candidate has extensive Quality Assurance experience in a GMP environment and experience in Validation in accordance with GAMP.

Review and approval of deliverables such as validation plans, user requirements, risk assessments, testing scripts, requirements tracing, and validation summary reports.

Support review and approved 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

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

All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.

RoslinCT is proud to be an equal opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.