Amandala Neuro
Quality Compliance Manager
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Quality Compliance Manager
Amandala Neuro · Remote (UK) · Full or Part time
About Amandala Neuro
Founded in 2025, Amandala Neuro is a rapidly-growing biotech startup spun out ahead of the strategic combination of Beckley Psytech and Atai Life Sciences (now AtaiBeckley) to enable focused development of ELE-101 (an IV dosage form of psilocin, the active metabolite of psilocybin), with a pipeline of follow-up candidates to address poorly-controlled neuropsychiatric conditions.
We are dedicated to helping patients suffering from neurological and psychiatric disorders by developing a pipeline of short-acting psychedelic compounds. Our vision is for clinically validated psychedelic medicines to be integrated into medical practice to help patients in need around the world suffering with these profoundly debilitating conditions.
The Opportunity
We are looking for a Quality Compliance Manager (QCM) to support the Head of Quality and be part of the Quality Department working closely across all functions supporting in all aspects of the Quality Management System.
Key Responsibilities
QMS SOPs and controlled documents
- Responsible key user for the setup oversight, administration, system update activities relating to the management and maintenance of the company’s Quality Management System (electronic validated environment) as the Key User.
- Ensure oversight for the Standard Operating Procedures (SOPs), including tracking, distribution, and maintenance of the SOP tracking systems. Inform the Head of Quality of any non-compliances on a routine basis.
- Maintenance and oversight for SOP matrix
- Managing the oversight for SOP compliance by the timely production of relevant oversight reports and contribution to quality summaries.
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Quality Issue and Vendor Management
- Responsible for the maintenance and continued development of quality issue tracking
Continual Improvement, support of the QMS, CAPA and Training
- Responsible for ensuring that the business is driven by continual improvement in quality by ensuring appropriate CAPAs are raised, supported, completed, and implementation checks are in place working along with other quality department members.
- Continual development and supporting activities across the QMS ensuring awareness across the GXPs. Continually assess and discuss with the Head of Quality and with the other quality team members, department heads/directors.
- Design and preparation of training presentations and materials, delivering training in areas of expertise and external vendors as required, i.e. inspection preparation training.
- Support training initiatives across the GXPs.
- Keep up to date with GXP and regulatory changes. Sharing this knowledge across the business and into its processes.
- Setting up and overseeing the structure for QMS documents in the eQMS. Supporting the quality department in developing and ongoing assessment of the storage environment, both paper and electronic. Ensure it is kept in line with changes in the regulatory environment. Supporting Archive activities across the business.
- Support Quality and other functions with computer system knowledge and data protection topics.
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Auditing and Inspection
- Support auditors conducting audits if required, i.e. CSV
- Manage, facilitate, and fully engage in regulatory agency inspections relating to activities, e.g. Interviewee and key user for eQMS setting up Inspector access to eQMS, preparing documents pre, during, and post inspection, hosting, ready room activities, etc.
- Perform all business-related activities that may be reasonably requested and as instructed by the respective Company Director or Head of Department
Skills and Attributes
The Quality Compliance Manager will require:
- Prior experience working with QMS systems covering GCP, GVP, GMP/GDP
- Knowledge of computer systems, data handling/security, and data validation is an advantage
- Experience including reviewing and writing SOPs, Training/Mentoring, QI tracking.
- Knowledge and experience in quality management familiar with regulatory procedures and GCP, GVP, GMP, GDP, etc.
- Highly organized, able to work on own initiative, with excellent attention to detail, able to produce high-quality work to agreed deadlines.
- Experienced in computer applications and business software.
- Excellent organizational, detailed, written, and verbal communication skills.
- Ability to be self-motivated and innovative.
Why Amandala
- You will be working on one of the most scientifically interesting programs in psychiatry right now.
- High ownership from day one — direct access to senior leadership, not layers of management.
- Remote-first with flexibility on location and working pattern.
- Meaningful equity participation for permanent roles.
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