Principal Quality Systems Specialist

RoslinCT

Hopkinton (MA)

On-site

USD 83,000 - 129,700

Full time

14 days+

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Job summary

RoslinCT, a leader in cell and gene therapy, seeks a Principal, QA - Quality Systems to oversee quality assurance tasks related to GMP-compliant systems and processes. This role involves enhancing quality workflows, compliance, and mentoring staff, contributing significantly to the company’s mission to develop impactful therapies.

Qualifications

8+ years in Quality Assurance within a regulated GMP environment.
3+ years Software Validation QA experience.
Experience with implementing quality systems is a plus.

Responsibilities

Support optimization of Quality Management Systems electronic workflows.
Lead site Data Integrity initiatives.
Mentor QA personnel and support internal audits.

Skills

Quality Assurance

Computer System Validation

Data Integrity

Continuous Improvement

GMP Regulations

Job description

Direct message the job poster from RoslinCT

Senior Talent Acquisition Manager at Taylor Strategy Partners a Syneos Health Company

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 escalate 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.

Seniority level