Compass Pathways
biotechnology
SeniorManager,QualityGMP/GDP(Contract)
“Senior Manager, Quality - GMP/GDP (Contract) at Compass Pathways. Skills: Quality, GMP, GDP, Commercial Readiness, Regulatory Compliance, Distribution Oversight. supporting the business in all GMP/GDP related activities as related to commercial product. 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”
Industry & Context.
Excellent problem-solving and risk management capability
What They're Looking For.
Must Have
10+ years in Quality within Pharma / Biotech / Life Sciences experience in: GMP and GDP regulations, Commercial product launches, Global regulatory interactions, 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), leadership and stakeholder management skills, Ability to operate in high-pressure, launch-driven environments, Excellent problem-solving and risk management capability, communication and influencing skills, Strategic mindset with attention to operational detail
Nice to Have
Experience in US product launches, Experience working with CMOs / CDMOs
What You'll Do.
supporting the business in all GMP/GDP related activities as related to commercial product
ensuring that products
and supply chains are fully compliant and inspection-ready to support successful commercial launch and ongoing distribution in line with GMP and GDP requirements
ensures seamless transition from development to commercial operations
with a focus on regulatory compliance
and cross-functional alignment
Execute Quality Commercial Readiness strategy for product launches
Define readiness criteria across: GMP (manufacturing
release) GDP (distribution
Lead readiness assessments and track progress against milestones
Ensure alignment with global regulatory requirements and expectations
Ensure distribution networks meet GDP standards: Warehousing Transportation Cold chain management
Oversee qualification of: Logistics providers Distribution partners
and product integrity requirements are met
Identify and manage risks impacting commercial readiness
Implement mitigation strategies for: Supply disruptions Compliance gaps Process robustness
How You'll Work.
Team & 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
Communication Scope
communication and influencing skills
Process & Methodology
Commercial Readiness Planning, Lead readiness assessments and track progress against milestones
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