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
Abcuro, Inc. is seeking a Director, QA Compliance to lead the Quality Assurance systems aspect of Quality for the strategic development of the Company’s quality programs and administration of the GxP Quality Systems ensuring GMP, GCP, and GLP compliance in accordance with US, EU, and global regulations. In this role you will manage the work of internal partners as needed to conduct all Quality Management System (QMS) activities. This position requires knowledge in current Good Manufacturing Practices (GMP), Good Distribution Practices, Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Documentation Practices (GDP) as well as relevant international guidance, such as ICH. The successful candidate will help promote a Quality culture of ethics, integrity, and continuous improvement. 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
- Business Owner responsibility for selecting, implementing, and overseeing the Quality Management System and governance practices
- Work with the Head of Quality and functional area management to build quality organization systems and processes to ensure compliance with all relevant oversight and regulations
- Lead development of Abcuro QMS, such as Quality Manual, Policies, standard operating procedures (SOP), Forms, Work Instructions and Templates, and manage compliance of these systems and tools
- Directly responsible for the management of the GXP Quality processes, such as Quality Agreements, GXP Deviation Management, Root Cause Analysis, Change Control, Corrective Action/Preventive Action, Document Control, batch release, complaints, GXP training, Quality Risk Management, and Metrics programs
- Lead Computer Software Assurance/Computer System Validation efforts, implementation, release change management, and periodic review of GxP computerized systems
- Provide QMS compliance expertise, interpretation, and active engagement to support early/late-stage clinical, technology transfer, BLA-enabling, and future commercial operations to ensure Abcuro maintains a state of compliance with all relevant guidelines
- Implement a compliant data management and archival process for all GXP documentation
- Responsible for GXP vendor qualification and audit programs
- Lead risk assessments, issue escalation, and continuous process improvement initiatives in close collaboration with cross-functional groups, as needed
- Define, monitor, and report quality performance metrics utilizing data analyses and trending
- Support review of regulatory submissions, amendments, and associated source data
- Develop, monitor and communicate Quality training requirements and compliance status
- Foster a quality mind-set within Quality and throughout the company by ensuring consistent, risk-based and innovative thought processes are employed to advise and make decisions
- Support inspections by regulatory authorities and maintain a state of inspection readiness
- Facilitate Quality Management Review activities, such as trending, presentations, and meetings.
- Stay current on relevant industry developments, forthcoming regulations, guidance, and best practices
EDUCATION AND WORK EXPERIENCE
- Bachelor’s degree in Chemistry, Biology, Engineering or related field plus six (6) years of manufacturing and/or laboratory experience in the Biopharma/Biotech GXP environment; OR Master’s Degree in the same, plus four (4) years relevant industry experience in Quality Assurance in a relevant Biopharma/Biotech GXP environment
- At least four (4) years of direct QA/GXP compliance experience working in biotechnology, biopharmaceutical, CRO or CDMO environment, ideally in an environment between early clinical through commercial drug product development lifecycle
- Comprehensive working knowledge of FDA and international ICH, GXP regulations, guidelines, and subsequent applications to drug development
- Demonstrated success in design, implementation and management of modern quality systems
- Strong understanding of creation and review of GXP documents, such as specifications, methods, protocols, reports, batch records, deviations, change controls, and CAPAs
- Risk management experience (e.g., Gap assessment, FMEA, PHA, etc.)
- Experience in inspection readiness efforts and/or supporting Health Authority inspections
- Demonstrated experience working successfully autonomously and on cross-functional teams
- Excellent verbal/written communication skills, including knowing when emails or conversations are appropriate
- Excellent attention to detail, project management and organizational skills
- Strong prioritization and problem resolution skills
- Ability to adapt in a fast-paced and dynamic environment with competing priorities
- Root Cause Analysis, Investigator and/or Operational Excellence (e.g., Lean Six Sigma, Kaizen, Black Belt qualification, etc.) skills are highly desirable
- Other responsibilities as assigned/delegated by management
Other Requirements:
- Up to 20% travel may be involved
- Hybrid or remote 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.
**Please direct all inquiries and/or CV submissions to careers@abcuro.com