Quality (Senior) Manager, Good Clinical Practice (GCP)

Responsibilities

• Develop, manage, and continuously improve the Quality Management System to ensure inspection readiness and compliance with GCP standards.
• Conduct or oversee external and internal GCP audits, including site, supplier, and process/system audits.
• Provide cross-functional GCP support by partnering with Clinical Operations, Regulatory Affairs, and external suppliers.
• Oversee the provision of GCP and quality training to relevant stakeholders.
• Maintain quality oversight of GCP suppliers, including qualification and requalification processes.
• Author and review written procedures related to GCP compliance implementation.
• Manage and administer the electronic Quality Management System (eQMS) and report on key quality metrics.

Requirements

• BSc or MSc in Life Science (biopharmaceutical, biomedical science, chemistry, pharmacy, or similar).
• Minimum of 8 years of GCP Quality Assurance experience in a pharmaceutical or biotech environment.
• Proven experience developing and implementing GCP audit programs for suppliers, processes, and Investigator Sites, specifically for Phase 3 Clinical Trials.
• Direct experience hosting or participating in regulatory inspections.
• Deep knowledge of EU, US, and ICH GCP regulations and industry standards.
• Expertise in risk management and CAPA development and implementation.
• Proficiency in eQMS and familiarity with EDMS or electronic batch record systems.
• Strong documentation skills and the ability to review and approve GCP records.
• Ability to travel to supplier or investigator sites as necessary.

Preferred Qualifications

• Experience working in drug development.
• Experience working with Controlled Drugs.

About the Company

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.