At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access.
We are headquartered in Cambridge, Massachusetts with a clinical manufacturing facility in Rockville, MD. This role will be based in Cambridge, MA.
We are looking for a Sr. Quality Associate to lead compliance of quality system events at TCR2 Therapeutics. As a member of the TCR2 Quality Systems and Engineering team, you will report to our Quality Systems Manager and work cross-functionally with members in GxP departments to ensure quality events are documented, monitored, and resolved in a timely and effective manner. In this role, you will have a direct impact on product quality, safety, and the overall quality culture of the organization, though the ownership and accountability of key elements of the quality management system.
Responsibilities
- Ensure a robust deviation management program is achieved with effective root cause analysis and corrective and preventative action(s) identified and completed.
- Lead investigations to facilitate proper root cause identification associated with nonconformances.
- Work with subject matter experts, area managers/directors and QA personnel to provide effective documentation, management, and execution of quality events (i.e. CAPAs, deviations)
- Ensure adequate risk assessments and event classifications are performed, using tools like Failure Mode Effect Analysis (FMEA)
- Define and perform effectiveness checks of Corrective and Preventive actions, when required
- Review and approve quality events and ensure timely closures of records
- Document and investigate Quality Assurance related deviations and escalate issues as appropriate to the Quality Assurance Lead in a timely manner
- Serve as process expert for quality events within the QMS
- Train individuals on quality processes and procedures
- Implement, enhance, and maintain quality system procedures and work instructions based on best practices or compliance requirements
- Represent the Quality System group in cross-functional projects where applicable
- Consult with management to develop and implement solutions for achieving quality related objectives
- Create, maintain, and distribute Compliance Quality Metrics to upper management on a routine basis, includes identifying, reporting, and escalating relevant Quality issues
- Create, maintain, and distribute quality metrics to upper management on a routine basis, includes identifying, reporting, and escalating relevant quality issues
- Support the internal and external audit program, as required
- Manage moderate complexity projects with minimal direction
- Author / write and review SOPs / documentation
- Mentor and train junior or new team members
- Other duties, as assigned
Requirements
- Bachelor’s degree in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering
- 4 years of related experience in GMP or Medical Device regulated industries
- Previous experience with the following quality processes is required: Change management, CAPAs, Deviations, Root Cause Analysis, Risk Management
- Experience identifying negative trends, gaps in compliance, and potential root causes, then defining and implementing actions to support continuous improvement of the quality management system
- Working knowledge and implementation of regulations and standards (i.e, 21 CFR part 11, 210/211, 606, 820, ISO 9001, ICH Q9/Q10 and EU industry standards)
- Proficient with Microsoft Suite (Word, Excel. PowerPoint), experience with Visio is a plus.
- Experience working with Veeva is preferred
- Ability to communicate clearly and effectively with all levels of the organization.
- Excellent verbal and written communication skills
- High level analytical and critical thinking skills
- Must be authorized to work in the U.S.