AtaiBeckley is a clinical-stage biopharmaceutical company created through the strategic combination of atai Life Sciences and Beckley Psytech, forming a global leader in transformative mental health therapies.

We are on a mission to transform patient outcomes by developing effective, rapid-acting mental health treatments, supported by an industry-leading pipeline of psychedelic-based therapies.

Our people are at the heart of our progress: a diverse, highly skilled, and values-driven team located across Europe and the US, united by a shared commitment to reducing the global burden of mental health conditions.

If you are motivated by meaningful science, real-world impact and working with experienced, mission-driven colleagues, we’d love to hear from you.

Role Overview:

The (Senior) GCP QA Manager will develop and provide quality oversight of GCP-related quality processes and activities. The role provides GCP quality oversight, supports regulatory compliance activities, manages quality system performance, and ensures inspection readiness. The Senior Manager partners cross-functionally with Clinical, Regulatory and Operations teams to embed compliance and drive quality excellence. This role reports to the Vice President, Quality and contributes to departmental strategy while managing day-to-day quality execution across GCP and eQMS operation.

Key Accountabilities:

1.     Develops, manages and continuously improves the Quality Management System to ensure inspection-readiness, and compliance with internal and external written standards for GCP, including conducting or overseeing external and internal GCP audits (site, supplier, process/system), and tracking and implementation of non-conformances

2.     Provides Cross-Functional GCP support by working closely with Clinical Operations, Regulatory Affairs, and external suppliers to align GCP Quality priorities, overseeing the provision of GCP and quality training to relevant stakeholders, representing the QA function in cross-functional project teams, contributing to clinical supply strategy, risk planning, and project timelines

3.     Maintains Quality oversight of GCP Suppliers, ensuring qualification and requalification and acting as the Sponsor Quality contact for GCP suppliers

4.     Authors and reviews written procedures related to the implementation of GCP compliance

5.     Manages, continuously improves and administrates the electronic Quality Management System (eQMS) including reporting of key quality metrics (eQMS)

Education, Experience and Skills necessary for the role:

• BSc or MSc in biopharmaceutical or biomedical science, chemistry, pharmacy, or another relevant Life Science degree.
• Proven experience (a minimum of 8 years) in GCP Quality Assurance in a pharmaceutical or biotech environment, with experience developing and implementing GCP audit programmes of suppliers, processes/system and Investigator Sites including for Phase 3 Clinical Trials.
• Prior experience hosting or participating in regulatory inspections.
• Strong knowledge of GCP regulations (EU, US, ICH) and industry standards.
• Experience in risk management, CAPA development and implementation.
• Excellent documentation skills; ability to review and approve GCP records, etc.
• Demonstrated cross-functional collaboration and communication skills.
• Ability to travel, where necessary, to supplier or investigator sites.
• Proficiency in quality management systems (QMS), and familiarity with electronic document management systems (EDMS) and/or electronic batch record systems.
• Experience working in drug development.  Experience of working with Controlled Drugs preferred but not required.