Principal – QA Validation

RoslinCT; Hopkinton (MA); On-site; USD 140,000 - 200,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Educational assistance

401(k) program

Job summary

RoslinCT is a world-leading cell and gene therapy CDMO seeking a Principal, QA - Validation to oversee validation activities for facilities and equipment in a GMP environment. The role involves review and approval of validation deliverables, governance of procedures, training content, and collaboration with cross-functional teams to ensure compliance and quality culture.

The ideal candidate will have extensive QA experience in pharma/biotech, hands-on validation QA experience, and a track record

Qualifications

• 8+ years of QA experience in pharma/biotech under GMP
• 3+ years of Validation QA experience
• Experience implementing quality systems and continuous improvement

Responsibilities

• Review and approve validation deliverables (plans, URS, risk assessments, testing scripts, traces)
• Approve executed protocols and associated records
• Investigate and remediate protocol discrepancies
• Review/approve deviations, change controls and CAPAs
• Support maintenance and upgrades of systems and utilities
• Assist with Health Authority inspections and client audits

Skills

QA Experience

Validation QA

cGMP knowledge

Job description

Who We Are

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.

Who We Are

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.

THE ROSLINCT WAY

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.

ACCELERATING YOUR FUTURE

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.

How You Will Make An Impact

• 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

WHAT YOU WILL BRING

• 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 elevate complex decisions as needed.
• Understanding of cGMP and ICH regulations/guidelines

Final compensation will be based on a variety of factors, including education, experience, technical expertise, specialized skill sets, market demand, internal equity, and business needs.

At RoslinCT, we offer more than just competitive pay. Our comprehensive Total Rewards package is designed to support your health, financial well-being, and professional development throughout your career. Benefits include medical, dental, and vision insurance, educational assistance, a 401(k) program, and a variety of additional resources to help you thrive both personally and professionally.

OUR COMMITMENT

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.