Who is BlueRock?
BlueRock is a leading engineered cell therapy company using its unique CELL+GENETM platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases.
The convergence of cell biology and genetic engineering is creating fundamental new ways to impact disease. Founded in 2016 to capitalize on these technological breakthroughs, we are advancing our novel CELL+GENE™ platform to develop, manufacture, and deliver an entirely new generation of authentic and engineered cell therapies across three therapeutic areas: neurology, cardiology, and immunology.
What Are We Doing?
Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit.
We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options.
We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients’ lives.
Description of Position:
The Cambridge, Massachusetts site is seeking a Clinical Operations Quality Specialist, reporting to the Senior Quality Assurance Specialist.
This is an outstanding opportunity for a talented individual to contribute to bringing a new class of medicines to patients and gain valuable career experience in translational medicine. Collaboration with a highly motivated, world-class team of scientists and engineers promises an exciting and engaging work environment for motivated, self-starting candidates.
The Clinical Operations Quality Specialist will be responsible for assisting in the maintenance of the Quality Management System (QMS) to support BlueRock’s Clinical Operations. Duties include assisting in the maintenance of GCP documents that are necessary for ensuring compliance with applicable U.S. standards, and to support Clinical Operations as requested to provide training, monitoring and site-supportive activities as required.
- Oversee auditing plans supporting Clinical Studies, including Site, CRO,, eTMF, Vendors, Internal (as needed), gap analyses and manage for cause audits.
- Ensure regulations and evolving guidelines are communicated through development of corporate policies and procedures.
- Review corporate files with respect to clinical quality, compare against current regulations, and report any serious risks or critical findings to senior management
- Prepare and participate in review and approval of Standard Operating Procedures and related documents to support GCP activities.
- Develop and provide training and mentoring about clinical quality, GCPs and SOPs to Clinical Operations staff and other personnel participating in Clinical Operations. Assist managers in identifying and maintaining training requirements for Clinical Operations personnel.
- Assist with identifying non-conformances, provide suitable recommendations and facilitate ongoing quality improvements using risk-based methodology while maintaining compliance with applicable study protocols, Quality System Regulations and regulatory standards where applicable. Manage CAPAs and follow up for the Clinical Development team.
- Manage the Clinical Quality Council and plan meetings, create quarterly agenda, and maintain minutes and action items.
- Work with the Senior Quality Assurance Specialist to maintain the electronic Quality Management System and serve as the GCP quality lead.
- Participate in Regulatory audits, as needed.
- Perform QA and QC review of clinical documentation
- Minimum of a Bachelor’s or Master’s degree, ideally in Life Sciences.
- Minimum of 5 years of relevant work experience is required.
- Direct experience in the following areas is required:
- Clinical Audit processes
- GCP Quality Systems
- Global GCP regulations (US/EU etc.); ICHE6 R2, 21 CFR Part 50, 54, 56, 312, 314, and high-level knowledge of 21 CFR Part 11 and International equivalents as necessary
- Clinical Documentation (e.g., Investigator’s Brochures, Clinical Study Reports, Protocols, etc.)
- Investigation, Root Cause Analysis, CAPA and Effectiveness check processes, tools, and techniques
- Risk management principles and process, change management
- Understanding of drug development life cycle, regulatory requirements, best practices and industry standards is a plus
- Ability to maintain attention to detail while executing multiple tasks.
- Excellent written and oral communication skills and the ability to work in a fast paced, dynamic team environment is required.
- Expertise using MS Word, Excel, and database programs. Experience working with MasterControl and Veeva is highly desirable.
- Ability to travel approximately 20-30% may be necessary for external auditing
Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.