Senior Quality Assurance Specialist

Position Title: Senior Quality Assurance Specialist

Reports to: Director, Quality Assurance

Status: Regular, Full-Time, Exempt

Location: Watertown, MA (Onsite)

Company Summary: Stratus Therapeutics is a stem cell therapeutic company developing an innovative platform technology for generating self-renewing blood stem cells. We have breakthrough potential to provide patients with rapid and broad access to HLA-compatible transgene-free blood stem cell therapies.

Stratus Therapeutics is committed to advancing science and enhancing the health and well-being of patients. This commitment, along with an exciting team culture, drives our efforts to develop an off-the-shelf-stem-cell therapeutic platform.

Position Summary: We are seeking a highly motivated and detail-oriented Senior Quality Assurance Specialist to join our growing team. This role is critical to ensuring the integrity, compliance, and excellence of our cell therapy products through all stages of development and manufacturing. The Senior QA Specialist will play a key role in maintaining our Quality Management System (QMS), supporting GMP activities, and contributing to the advancement of our regenerative medicine pipeline.

Specific responsibilities include, but are not limited to:

• Ensure that manufacturing, testing, and release activities comply with cGMP, ICH, FDA, EMA, and other applicable regulations
• Perform review and approval of GMP documentation including, batch records, quality control test data, technical reports to ensure compliance with GMP and regulatory standards
• Manage the issuance and/or revision of controlled GMP documentation including production batch records, logbooks, labels and forms ensuring compliance with document control procedures
• Lead and support internal and external audits
• Maintain a document control system, ensuring that all documents are properly tracked, version-controlled, and readily available to authorized personnel
• Conduct quality investigations of non-conformances, deviations, and CAPAs; support root cause analysis and follow-up
• Collaborate with manufacturing, QC, and process development teams to ensure quality is built into all processes
• Review and approve SOPs, protocols, validation documents, and change controls
• Conduct internal audits and routine QA walkthroughs in GMP manufacturing areas
• Support supplier qualification program including material release
• Support training and onboarding of personnel on QA and GMP topics
• Ensure documentation is maintained accurately and timely in compliance with GDP (Good Documentation Practices). Support the document archival process.
• Maintain an understanding of regulatory trends and guidelines relevant to advanced therapy medicinal products (ATMPs)
• Perform risk assessments and contribute to continuous quality improvement initiatives
  
  

Qualifications include:

• Bachelor’s degree in scientific discipline (e.g., Biology, Biochemistry, Biotechnology, Engineering or related field).
• 5 years of experience in Quality Assurance within a GMP-regulated environment, preferably in cell/gene therapy or biologics industry
• Strong knowledge of FDA, EMA, and ICH regulations
• Excellent attention to detail and organizational skills
• Strong verbal and written communication skills
• Ability to work in a fast-paced, dynamic environment and collaborate effectively across teams
• Must be able to laugh and contribute to a positive work culture
  
  

AAP/EEO Statement

Stratus Therapeutics is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

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