Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job overview:
The Senior Manager, Quality - GMP/GDP is responsible for supporting the business in all GMP/GDP related activities as related to commercial product. This position is responsible for ensuring that products, processes, systems, and supply chains are fully compliant and inspection-ready to support successful commercial launch and ongoing distribution in line with GMP and GDP requirements. This role ensures seamless transition from development to commercial operations, with a strong focus on regulatory compliance, inspection readiness, and cross-functional alignment. Director, Product Quality. United Kingdom (Home-based or office-based/hybrid in our London office). 9-month contract.
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Reports to:
Location:
Duration:
Roles and responsibilities
(Include but are not limited to)
Commercial Readiness Planning
Execute Quality Commercial Readiness strategy for product launches
Define readiness criteria across:
GMP (manufacturing, QC, release)
GDP (distribution, logistics, temperature control)
Lead readiness assessments and track progress against milestones
Ensure alignment with global regulatory requirements and expectations
GDP Readiness & Distribution Oversight
Ensure distribution networks meet GDP standards:
Warehousing
Transportation
Cold chain management
Oversee qualification of:
Logistics providers
Distribution partners
Ensure traceability, serialization, and product integrity requirements are met
Cross-Functional Collaboration
Partner with:
Manufacturing & Supply Chain
Regulatory Affairs
Technical Operations
Commercial teams
Ensure alignment on launch timelines and risk mitigation
Serve as Quality SME for commercial readiness governance forums
Risk Management
Identify and manage risks impacting commercial readiness
Implement mitigation strategies for:
Supply disruptions
Compliance gaps
Process robustness
Candidate Profile:
Education: Bachelor’s or master’s degree in: Pharmacy, Life Sciences, Engineering or related field
Experience: 10+ years in Quality within Pharma / Biotech / Life Sciences
Strong experience in: GMP and GDP regulations, Commercial product launches, Global regulatory interactions
Technical Skills: Deep knowledge of EU GMP / FDA 21 CFR Parts 210/211 and GDP Guidelines (EU GDP 2013/C 343/01)
Understanding of: Serialization and supply chain compliance, Validation lifecycle (IQ/OQ/PQ) and Familiarity with eQMS systems
Leadership & Behavioural Competencies: Strong leadership and stakeholder management skills, Ability to operate in high-pressure, launch-driven environments, Excellent problem-solving and risk management capability, Strong communication and influencing skills, Strategic mindset with attention to operational detail
Preferred Experience: Experience in US product launches, Experience working with CMOs / CDMOs
Benefits & Compensation:
For an overview of our benefits package and compensation information, please visit "Working at Compass".
