Quality Assurance Lead, Plant Operations

RoslinCT US; Hopkinton (MA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k)

Job summary

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization with a strong focus on quality and regulatory excellence. The Quality Assurance Lead, Plant Operations, will oversee QA activities at our Hopkinton, MA site and work to ensure compliant manufacturing operations.

This on-site role requires leadership, rigorous attention to detail, and collaboration across teams.

Qualifications

• 7+ years of QA experience in pharma/biotech with internal manufacturing.
• Leadership or supervisory experience.
• Strong knowledge of cGMP and ICH regulations/guidelines.

Responsibilities

• Supervise and lead Quality Assurance team, including coaching and mentoring.
• Coordinate day-to-day operations for the QA team, including batch record review and deviations.
• Provide QA support to manufacturing operations and ensure GMP compliance.
• Monitor implementation of QA procedures and identify improvement opportunities.
• Work cross-functionally to develop and approve manufacturing procedures/workflows.

Skills

Quality Assurance

Leadership

cGMP compliance

Problem solving

Communication skills

Microsoft Office

Tools

Microsoft Office

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 Quality Assurance Lead, Plant Operations, is responsible for leading QA plant operations and expertise in manufacturing plant operations. This includes batch review, product disposition, review and approval of GMP documentation including but not limited to QC test methods and Work Order Records. The candidate will lead product receipt, shipment and disposition, line clearance and quality system review/ approval in the QA role. This is a full-time, on-site role at our Hopkinton, MA location. Weekends and holidays may be required.

How You Will Make an Impact:

• Supervise and lead Quality Assurance team, including coaching and mentoring.
• Coordinate day-to-day operations for the Quality Assurance team. This includes but is not limited to oversight of batch record review, QC data review, deviations, CAPA, Change Control, and training.
• Provide QA support to manufacturing operations and ensure compliance with cGMP requirements.
• Monitor implementation of QA specific procedures for compliance and identify opportunities for improvement
• Work cross functionally and provide QA support for development, review and approval of procedures/workflows for manufacturing operations
• Provide QA review and approval of plant related SOPs and GMP documentation
• Other duties as assigned.

What You Will Bring:

• A highly organized work style that ensures timely execution of tasks.
• A mindset that ensures accurate results.
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
• Effective problem-solving capabilities.
• Strong oral and written communication skills.

Qualifications:

• 7+ years of relevant Quality Assurance experience in a pharma/biotech company with internal manufacturing. Cell therapy experience preferred.
• Previous leadership or supervisory experience
• Prior experience in Quality Assurance Operations focused on support of internal manufacturing operations.
• Prior experience working in contract services and interfacing with clients preferred
• Ability to partner cross functionally and be quality lead within agreed timelines to support plant start up activities
• Ability to resolve issues and make decisions independently and elevate complex decisions as needed.
• Partner cross functionally and provide quality support within agreed timelines to support plant start up activities.
• Well versed in cGMP and ICH regulations / guidelines
• Strong verbal and written communication skills

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.