Principal, QA- Quality Systems

RoslinCT US; Hopkinton (MA); On-site; USD 130,000 - 185,000; Full time

Job summary

RoslinCT US in Hopkinton, MA, seeks a Principal, QA - Quality Systems to provide QA oversight of Quality Systems and Computer System Validation. The role focuses on review/approval of CSV deliverables, governing procedures, and training content for computerized systems within a GMP environment.

The ideal candidate has extensive QA experience in pharma/biotech, with 3+ years in Software Validation QA and a strong background in 21 CFR Part 11/Annex 11.

Qualifications

• 8+ years of QA experience in pharma/biotech with GMP environment.
• 3+ years Software Validation QA experience.
• Experience implementing quality systems and continuous improvement initiatives.
• Cross-functional collaboration during development and implementation of quality systems.
• Independent and timely objective-driven work.
• Understanding of cGMP and ICH guidelines.

Responsibilities

• Provide QA oversight of Quality Systems and Computer System Validation.
• Review/approve deviations, change controls, and CAPAs as needed in CSV, Data Integrity, and QMS.
• Lead site Data Integrity initiatives and 21 CFR Part 11/Annex 11 alignment.
• Support GMP readiness and inspections including responses and CAPAs.
• Mentor QA personnel and promote a quality culture across functions.

Skills

QA experience

Software Validation QA

Cross-functional partner

Independent work

Decision making

cGMP/ICH 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.

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 - Quality Systems is responsible for providing QA oversight of Quality Systems and Computer System Validation. This includes supporting review and approval of new Computer System Validation deliverables, governing procedures and training content for computerized systems, as well as supporting maintenance and optimization of software systems and computerized equipment. The ideal candidate has extensive Quality Systems experience in a GMP environment and experience in Computer System Validation in accordance with GAMP.

HOW YOU WILL MAKE AN IMPACT

• Support optimization Quality Management Systems electronic workflows such as Deviations, Change Controls, CAPAs, Internal Audits, Client Audits and Inspections
• Support implementation of GMP software systems through review and approval of Computer System Validation deliverables.
• Support ongoing maintenance and upgrade to existing systems.
• Lead site Data Integrity initiatives
• Support the evaluation of systems for compliance with 21 CFR Part 11 and Annex 11.
• Optimize workflows and support updates to standard operating procedures and learning content for the Quality Systems Programs.
• Support monitoring of implementation of Quality System Programs, ensuring compliance to SOPs and identifying areas for improvement
• Support implementation and QA training to new systems
• Review/Approve Deviations, Change Controls and CAPAs as necessary (as is pertains to CSV, Data Integrity, Quality Management Systems, etc)
• Mentor personnel within QA and cross functionally on Quality Systems to promote a quality culture
• Support internal audits and GMP readiness (as assigned)
• 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 Software 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 eclipse complex decisions as needed.
• Understanding of cGMP and ICH regulations/guidelines

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.