Quality Assurance Manager – GMP

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.

The GMP Manager will develop and provide quality oversight of GMP-related manufacturing processes and activities associated with Investigational Medicinal Products (IMPs) for clinical trials. This role ensures that all drug

substances,

drug

products and finished investigational products are manufactured, released, stored, distributed, and disposed in compliance with applicable GMP regulations, ICH guidelines, and

Sponsor:Supplier

Quality Technical Agreements. The GMP QA Manager is the primary internal quality interface with Contract Development and Manufacturing Organizations (CDMOs), Qualified Persons (QPs), regulatory authorities, and cross-functional Chemistry and Manufacturing Control / Clinical Supply Management teams.

• Develop,maintain, and implementSponsor GMP quality systems and standard operating procedures (SOPs) relevant to clinical manufacturing.

• Review and approve GMP documentation from CDMOs (e.g., batch records, deviations, change controls, validations, investigations).

• Perform or oversee audits (site, vendor, supplier) of manufacturing and packaging vendors to ensure GMP compliance.

• EnsureGMP non-conformancesare appropriately tracked, implemented, and closed.

• Drive quality improvement initiatives related to GMP processes, documentation quality, andGMP supplierperformance.

• Develop and track quality metrics (KPIs) relevant toGMP Quality Management

• Prepare and respond to internal or external GMP inspections.

• Support CAPA planning and management following audit or inspection findings.

• Set up and manage Quality Technical Agreements (QTAs) with GMP third party suppliers

• Act as theSponsor’s quality contact for CDMOs;participatein technical and quality meetings.

• Support qualification,selection, and ongoing oversight of manufacturing and analytical service providers.

• Support GMP-related inspections (by regulatory authorities orSponsorAudits) at CDMO sites.

• Ensure all GMP processescomply withapplicable regulations (e.g., EU GMP, US cGMP), ICH guidelines, and local regulatory requirements.

• Ensure updates to applicable regulations and guidance related to GMP are communicated as relevant toimpactedparties, andreflected in written procedures.

• Work closely with Clinical Operations, Regulatory Affairs, CMC, and External Manufacturing to alignGMP Qualitypriorities.

• Oversee the provision ofGMP quality training to relevant stakeholders (e.g., clinical teams, regulatory teams).

• Represent the QA function in cross-functional project teams, contributing to clinical supply strategy, risk planning, and project timelines.

• Conductor support GMPrisk assessments (e.g., QRM) relating to manufacturing, supply chain, and QC issues.

• Reviewrisk mitigation strategies andmonitortheir implementation.

• Review deviations, OOS (out-of-specification) results, and non-conformances — ensuring root-cause investigations and CAPAs are robust.

• Bachelor orMastersDegree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or a related discipline. Advanced degree preferred.

• Proven experience (a minimum of5years) in GMPQualityAssurance in a pharmaceutical or biotech environment, with experience overseeing manufacturing of clinical-phase productsincluding Phase 3 Clinical Trials.

• Prior experience working with CDMOs, includingconductingaudits,preparingquality agreements,hostingorparticipatingin regulatoryinspections.

• Strong knowledge of GMP regulations (EU, US, ICH) and industry standards.

• Experience in risk management (QRM), CAPA management, deviation investigations.

• Excellent documentation skills; ability to review and approve GMP records, batch records, etc.

• Demonstrated cross-functionalcollaborationand communication skills.

• Ability to travel, where necessary, to manufacturing or partner sites.

• Proficiencyin quality management systems (QMS), and familiarity with electronic document management systems (EDMS) and/or electronic batch record systems.

• Experience of working with Controlled Drugspreferred but notrequired