About March Biosciences
March Biosciences, Inc is a clinical-stage cell therapy company with a mission to transform patient care in the most challenging hematological malignancies. March Bio’s lead asset is at the end of Phase I trials for T-cell malignancies, diseases with a dismal prognosis that is currently unaddressed by CAR-T and targeted therapy technologies. The company’s pipeline is designed to expand on these early successes to more broadly impact other high-challenge cancers.
About the job
We are seeking a detail-oriented and highly experienced Quality Assurance Specialist II or III to join our team in ensuring compliance with regulatory standards and internal quality systems. This role plays a key part in maintaining product quality and integrity, driving continuous improvement, and supporting quality-related activities.
Responsibilities
- Lead executed manufacturing and testing document review and Final Product release.
- Lead and support investigations of deviations, non-conformances, and CAPAs.
- Author Quality related documents (including but not limited to SOPs, forms, plans, protocols and work instructions).
- Provide quality review of documents (including but not limited to SOPs, forms, plans, master batch records, protocols, reports and work instructions).
- Participate in audits and support regulatory inspections.
- Collaborate with cross-functional teams to resolve quality issues.
- Evaluate and approve change controls, risk assessments, and supplier qualifications.
- Provide QA support during product development, tech transfers, and validation activities.
Qualifications
- Bachelor’s degree in a scientific discipline.
- 3-5 or 5–7 years of experience in pharmaceutical QA or a related GMP-regulated environment.
- Strong knowledge of cGMP, ICH guidelines, and applicable FDA regulations.
- Experience with document management systems and quality management software.
- Excellent attention to detail, problem-solving skills, and ability to manage multiple priorities.
Preferred Skills
- Experience in sterile/aseptic manufacturing, biologics, or Cell and Gene Therapies.
- Effective communication and interpersonal skills; team-oriented mindset.
Interested parties should apply to Olga Meystelman at olga@march.bio. Please be sure to include that this is an application for the Position.