Our Purpose: EMPOWER CELLS TO CHANGE LIVES
At SQZ Biotechnologies we believe that our cell therapies will revolutionize the way we treat diseases. Our unique capabilities enable us to engineer almost any function into any cell type, breaking down the barriers in the field, and creating the possibility for cell therapies that could not have been previously envisioned.
- Patients are the Purpose: We strive to transform patient quality of life so they can focus on living.
- Squeeze Together: We are one team with one goal. Only through the sum of our strengths can we achieve our shared purpose.
- Own the Outcome: We are what we do. Integrity and accountability are fundamental.
- Challenge the Now: We fearlessly drive innovation by questioning what is possible, fostering creativity, and executing on our ideas.
We are seeking an experienced industry expert as a Manager/Senior Manager to join the Quality Assurance (QA) team at SQZ Biotechnology. The successful candidate will report into the head of quality at SQZ and support good manufacturing practices (GMP) quality processes. The candidate will oversee QA activities performed externally at SQZ Biotechnology suppliers, contract manufacturing organizations (CMO) and contract laboratories. The candidate will work cross-functionally across the SQZ CMC, Clinical and Regulatory teams. The candidate will maintain strong business relationships with counterparts within external suppliers and contract organizations. The candidate will start out as an individual contributor with the potential to lead a team.
- Develop and implement standards, policies and procedures for quality compliance
- Support SQZ document management, training, change control and CAPA programs
- Facilitate and participate in audits of contract organizations and lead the supplier management program
- Review and approve documentation, change requests, master and executed batch records, packaging, labeling, analytical records, change orders and lot release for GMP materials.
- Provide QA support for regulatory filings and clinical activities as needed
- Provide status reports and relevant metrics to department and management
- Independently and collaboratively multitask in a dynamic multifunctional environment
- Be capable of analyzing a wide variety of data and managing potential compliance risks
- Have a fundamental grasp of the biopharmaceutical drug development processes and scientific methods
- Demonstrate strong leadership skills and experience working with all levels of management
- Fulfill primarily office-based position requiring 0-20% domestic and international travel
- BS in scientific field (Chemistry, Biology, Biochemistry, Chemical Engineering) with 7+ years of increasing QA responsibilities in GMP regulated biotech, pharmaceutical, or CMO organization
- Outstanding communication skills (interpersonal, verbal and written)
- Keen understanding and application of regional regulatory requirements specific to GMPs
- Proficiency in MS Office applications (Word, Excel, Power point, Project) and Quality System Databases
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.
Location/Region: Watertown, MA (02472)