QA Senior Manager, GCP Compliance & Auditing
Our Purpose: Empower Cells to Change Lives®
At SQZ Biotechnologies (NYSE: SQZ), we aim to improve patient care around the world by unlocking the full potential of cell therapies. We are inspired by the belief that we can make safer and more effective cell therapies for more diseases, and in doing so, transform patient outcomes. And by developing solutions that would allow for streamlined manufacturing, we see a future where cell therapies are accessible to more patients.
We are seeking an experienced and collaborative Good Clinical Practices (GCP) industry expert to join our growing Quality Assurance (QA) team and to provide hands-on support for QA activities related to the clinical supply of cell therapy product(s) at SQZ. As a Senior Manager, you will focus on the qualification and auditing of clinical vendors, investigator sites, and service providers, and ensure our internal systems comply with GCP regulations. Working cross-functionally and with our external counterparts at contract organizations and clinical sites, this will be a dynamic and vital role with high growth potential.
- Contribute to the development, implementation, and maintenance of Good Clinical Practices (GCP) Quality Management program and procedures.
- Manage the development and execution of risk-based audit schedule by planning and conducting (re)qualification audits of non-clinical/clinical CROs, clinical sites, and service providers to ensure compliance with our program, as well as industry regulations and guidelines.
- Track corrective actions, oversee consultant mediated audits and auditing of TMFs, and ensure Clinical activities are compliant with GCP, GCLP, FDA, ICH, EMA regulations and guidelines and industry standards.
- Lead the Quality Agreement (QAG) life-cycle process for clinical vendors, investigator sites, and service providers.
- Identify GCP study supplier and service provider metrics; communicate findings and compliance of clinical trials to senior management and team.
- You possess six+ years of industry experience in Sponsor companies, CROs, or GCP consulting – a BS in Nursing or Clinical/Medical Science is a plus.
- Knowledgeable about global GCP regulations and have experience leading and conducting biopharmaceutical GCP audits.
- Adept at analyzing a wide variety of data and managing potential compliance risks, while remaining flexible to meet the QA needs for on-demand clinical trial material manufacture.
- Proficiency in study monitoring activities, and sound judgement and commitment to ethical product.
- Able to assess complex issues, propose viable solutions, and communicate in an effective and professional manner.
- Self-motivated, strong time-management and interpersonal skills, and a team-oriented mindset.
- Proficient in MS Office applications (Word, Excel, PowerPoint, Project) and Quality System Databases.
- Experience working in the cell therapy industry, with the FDA and external authorities, with RBQM, and/or possession of licenses or certifications such as the ASQ, SQA, etc., would be a bonus but should not keep you from applying to this position.
Please Note: This is an on-site position based out of Watertown, MA, requiring up to 20% domestic and international travel. Although flexible work arrangements can be made, on-site support is expected.
SQZ Biotechnologies is proud to be an equal opportunity employer and to provide equal opportunities to all employees and applicants for employment without regard to race, color, religion, sex or gender identity, national origin, age, disability, sexual orientation, or genetics. In addition to federal law requirements, SQZ complies with applicable state and local laws governing nondiscrimination in employment.