Senior Manager, Quality - GMP/GDP (Contract)

Senior Manager, Quality - GMP/GDP (Contract)

London, United Kingdom

Company overview

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, US. It focuses on developing treatment options that could improve the lives of those suffering with mental health conditions and who are not helped by current treatments.

Job overview

The Senior Manager, Quality - GMP/GDP supports all GMP/GDP-related activities for commercial products, ensuring that products, processes, systems and supply chains are compliant and inspection-ready for launch and ongoing distribution. The role bridges development and commercial operations, focusing on regulatory compliance, inspection readiness and cross-functional alignment.

Reports to: Director, Product Quality
Location: United Kingdom (home-based or hybrid in our London office)
Duration: 9 month contract

Roles and responsibilities

• Commercial Readiness Planning
  • Execute Quality Commercial Readiness strategy for product launches
  • Define readiness criteria across GMP (manufacturing, QC, release) and 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
  • Warehouse oversight
  • Transportation management
  • Cold chain management
  • Oversee qualification of logistics providers and distribution partners
  • Ensure traceability, serialization and product integrity requirements are met
• Cross Functional Collaboration
  • Partner with manufacturing & supply chain, regulatory affairs, technical operations and commercial teams
  • Align on launch timelines and risk mitigation
  • Serve as Quality SME for commercial readiness governance forums
  • Identify and manage risks impacting commercial readiness (supply disruptions, compliance gaps, process robustness)

Candidate profile

• Education: Bachelor's or master's degree in Pharmacy, Life Sciences, Engineering or a related field
• Experience: 10+ years in Quality within Pharma/Biotech/Life Sciences
• Strong experience in GMP and GDP regulations, Commercial product launches and 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), 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: US product launches, working with CMOs/CDMOs

Benefits & Compensation

For an overview of our benefits package and compensation information, please visit "Working at Compass".

Equal opportunities & diversity

We are committed to building a workplace where everyone's wellbeing matters. UK and US applicants are welcome to request reasonable accommodation. Compass Pathways proudly supports diversity and equality under the Equality Act 2010 (UK) and relevant U.S. laws.

Sponsorship

We cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying.

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Contact & application

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