Abcuro, Inc. is a clinical-stage biotechnology company developing protein-based treatments for serious autoimmune and cancer indications modulated by cytotoxic T and NK cells that express the inhibitory immune checkpoint receptor KLRG1 (killer cell lectin-like receptor G1). The company is advancing ABC008, a first-in-class anti-KLRG1 antibody designed to deplete cytotoxic T cells that attack healthy muscle tissue in patients with inclusion body myositis (IBM), into clinical studies.
POSITION SUMMARY
This role will be responsible for ensuring the Abcuro Quality Management System (QMS) is in compliance with applicable GxP regulations, guidance, industry standards and best practices. This entails GxP Quality activities that are performed either internally or outsourced externally to contract manufacturing and testing facilities. These activities include but are not limited to managing the GxP QMS, Quality processes, document control, audit management, batch record review, lot release, deviations, CAPAs, change controls, training, and metrics. This role will be reporting to the Director of QMS in the Quality Assurance function.
Abcuro offers a dynamic and highly collaborative work environment with a generous compensation and benefits package. We welcome inquiries from qualified, enthusiastic candidates with a passion for excellence.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
- Actively support the development and management of the QMS system, such as developing standard operating procedures (SOP), policies, forms, templates, and work instructions.
- Assist with the production of SOPs, quality agreements, specifications, certificate of analysis (CoA), protocols, reports, memos, and technical documents according to specific format standards and guidelines to ensure compliant documents in the electronic document management system.
- Document Control – Proofread/spell check documents for accuracy, consistency of formatting, and use of terminology to endorse quality.
- Provide support on Computer System Validation of GxP computerized systems, as needed
- Ensure GxP processes and project execution are conducted in accordance with SOPs, guidelines, and regulations
- Track and perform review of all actions as defined in GxP deviations, change controls, CAPAs, complaints and non-compliance events to ensure timely closure
- Support the review, batch release and archival of contract manufacturing batch production records, supplemental records, in-process, stability and CoA release analytical data
- Provide source data verification of Certificate of Analysis (CoA), stability summaries, qualification/validation, specifications, master label proofs, technical protocols/reports, including regulatory submissions, as applicable.
- Define, collect, monitor, and report quality performance metrics utilizing data analysis and trending tools, as applicable.
- Provide support on risk assessments and continuous improvement utilizing tools such as FMEA, process excellence, root cause analysis (RCA) and quality risk management
- Support on-site regulatory inspections and Abcuro audit program
- Other responsibilities as assigned/delegated by management, as appropriate
EDUCATION AND WORK EXPERIENCE
- Bachelor’s Degree in Biology, Chemistry, Engineering or related field with a minimum of 5 years of experience in the biopharmaceutical/biotechnology industry; or Master’s Degree in Biology, Chemistry, Engineering or related field plus minimum of 3 years relevant industry experience in Quality Assurance in the Pharma/Biotech GMP environment
- Familiarity or experience with multiple of the following: cGMP / GLP / GDP / GCP, (e.g. FDA, EU, MHRA, ICH, WHO, ISO)
- Experience with Quality Management System
- Experience with creation and review of GxP documents such as specifications, CoAs, technical protocols/reports, batch records, deviations, change controls, and CAPAs
- Experience with Vendor Management is desirable
- Investigator, Auditing, RCA, and/or Operational Excellence (e.g., ASQ Certified Quality Auditor, RCA facilitator, Lean Six Sigma or process mapping) skills are desirable
- Excellent verbal and technical writing skills, including knowing when email or conversations are appropriate
- Excellent attention to detail, prioritization, and organizational skills
- Ability to adapt in a fast-paced environment with evolving priorities is desirable
- Demonstrated experience working autonomously and on cross functional teams
- Candidates must be authorized to work in the U.S.
OTHER REQUIREMENTS
- Up to 10% travel may be necessary
- Hybrid working environment offered
Abcuro believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of any legally protected status. Abcuro will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.