Manager, Quality Assurance Plant Operations

About Us

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.

Responsibilities

• Lead the day-to-day operations for the Quality Assurance team, including oversight of product disposition, deviation, CAPA, Change Control, internal audit, and training.
• 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.
• Support product disposition and shipping.
• Support Health Authority Inspections and Client Audits.
• Mentor personnel within QA and cross-functionally on GMP compliance, promote quality culture.
• Act as QA lead for tech transfer, client projects, and GMP-related activities.
• Partner cross-functionally and provide quality support within agreed timelines to support plant start-up activities.
• Resolve issues and make decisions independently; escalate complex decisions as needed.
• Other duties as assigned.

Requirements

• 8+ years of relevant Quality Assurance experience in a pharma/biotech company with internal manufacturing. Cell therapy experience preferred.
• Minimum 2 years of leadership experience as a supervisor/leader or manager.
• 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 a quality lead within agreed timelines to support plant start-up activities.
• Well-versed in cGMP and ICH regulations/guidelines.
• Strong verbal and written communication skills.
• Highly organized work style that ensures timely execution of tasks.
• Mindset that ensures accurate results.
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
• Effective problem-solving capabilities.

Schedule

This is a full-time, on-site role at our Hopkinton, MA location. Weekends and holidays may be required.