Quality Assurance ManagerAtaiBeckley • London, England, United Kingdom
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Quality Assurance Manager
AtaiBeckley
- London, England, United Kingdom
- London, England, United Kingdom
À propos
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 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.
Quality Assurance Oversight (40%)
Develop, maintain, and implement Sponsor 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.
Ensure GMP non-conformances are appropriately tracked, implemented, and closed.
Drive quality improvement initiatives related to GMP processes, documentation quality, and GMP supplier performance.
Develop and track quality metrics (KPIs) relevant to GMP 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 the Sponsor’s quality contact for CDMOs; participate in technical and quality meetings.
Support qualification, selection, and ongoing oversight of manufacturing and analytical service providers.
Support GMP-related inspections (by regulatory authorities or Sponsor Audits) at CDMO sites.
Regulatory Compliance & Documentation (15%)
Ensure all GMP processes comply with applicable 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 to impacted parties, and reflected in written procedures.
Cross-Functional Collaboration (15%)
Work closely with Clinical Operations, Regulatory Affairs, CMC, and External Manufacturing to align GMP Quality priorities.
Oversee the provision of GMP 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.
Quality Risk Management (10%)
Conduct or support GMP risk assessments (e.g., QRM) relating to manufacturing, supply chain, and QC issues.
Review risk mitigation strategies and monitor their implementation.
Review deviations, OOS (out-of-specification) results, and non-conformances — ensuring root-cause investigations and CAPAs are robust.
Education, Experience and Skills
Bachelor or Masters Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or a related discipline. Advanced degree preferred.
Proven experience (a minimum of 5 years) in GMP Quality Assurance in a pharmaceutical or biotech environment, with experience overseeing manufacturing of clinical-phase products including Phase 3 Clinical Trials.
Prior experience working with CDMOs, including conducting audits, preparing quality agreements, hosting or participating in regulatory inspections.
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-functional collaboration and communication skills.
Ability to travel, where necessary, to manufacturing or partner sites.
Proficiency in quality management systems (QMS), and familiarity with electronic document management systems (EDMS) and/or electronic batch record systems.
Experience of working with Controlled Drugs preferred but not required.
Seniority level Associate
Employment type Full-time
Job function Quality Assurance
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Compétences linguistiques
- English
Avis aux utilisateurs
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