Quality Lead
Vor 2 Tagen
Anjarium is a privately held, early-stage biotechnology company focused on creating a new class of non-viral gene therapies to deliver more predictable, enduring, and inclusionary ways to tackle genetic disease throughout a patient’s lifetime. The Company’s versatile platform aims to leverage breakthrough science and expertise at the interface of genetic medicine, synthetic biology and nanoparticle engineering to generate a pipeline of advanced gene therapies with unique competitive advantages over current viral-vector based gene therapies. We are backed by leading international and strategic investors Abingworth, Gimv, Omega Funds, Pfizer Ventures and Surveyor Capital (a Citadel company).
Currently headquartered at Biotechnopark in Zurich, Switzerland, we are rapidly expanding our teamand are looking for talented and creative individuals, driven by patient outcomes, to join us. Our team is passionate about building a new generation of durable genetic medicines for life-threatening diseases while pushing forward the frontiers of gene therapy.
**About the Role**:
The successful
**Quality Lead **will have at least 3 years of experience within Quality Assurance in (Bio)pharmaceutical industry and is familiar with QMS and project management.
**Key Responsibilities**:
- Implement the quality processes (QMS) and controls for the assigned projects and effectively align with the partners and the program priorities
- Support the R&D and CMC teams in defining and executing the quality strategy, in line with the global vision, specifically to: manage the non-viral delivery systems, plasmids and critical raw materials’ manufacturing technologies as well as support in selecting CROs and CDMOs
- Ensure timely operational excellence, delivery of high-quality products and documentation
- Provide quality support and expertise during manufacturing campaigns as Quality Assurance representative, including leading investigations, implementing appropriate CAPAs and Efficacy reviews
- Communicate effectively and proactively to department and site leadership and within external forums
- Actively oversight best practices, trainings, and cross-functional support within the teams
- Ensure that all solutions and products are delivered in compliance with all pertaining corporate and legal HSE and quality guidelines and requirements
- Ensure alignment with all required regulation and guidelines in Operations and Projects in order to guarantee permanent regulatory readiness
- Influence/persuade others and work according to appropriate SOP’s, GDevP, GLP, GMP, OQM, HSE, and Anjarium values
**Qualifications and Experience**:
- Bachelor in a Life Sciences or Chemistry/Biotech-related field
- Minimum of 3 years of experience within Quality Assurance in Biopharmaceutical industry
- Familiar with main regulator's quality standards and processes
- Mastering of Root cause analysis and risk management tools
- Strong written and verbal communicator in English
**Key Interpersonal Skills**:
- Excellent problem-solving skills, and comfortable to work within a fast-paced environment
- Analytical, critical-thinking, and problem-solving skills to review systems, identify quality issues and lead effective root cause investigations
- Pays attention to detail
- Open minded and easily approachable person, strong collaboration and team working skills
- Critical thinker that is not afraid to question current methods and likes to ask questions
- Motivated and able to perform multiple tasks simultaneously
- Enjoys working in both ways: on independent work and team projects
- High personal standards with requirements in return for their working environment such as transparency, respect and caring communication
- Submission of unsolicited resumes in advance of an agreement between Anjarium and any external staffing agency or recruiter does not create any implied obligation on the part of Anjarium Biosciences AG. _
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