Senior Manager, Quality - GMP/GDP (Contract) at Compass Pathways

<div class="content-intro"><p><span style="font-size: 14pt;"><strong>Company introduction:</strong></span></p> <p><span style="font-size: 12pt;">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.   </span></p> <p><span style="font-size: 12pt;">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. </span></p> <p><span style="font-size: 12pt;">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. - </span><a style="font-size: 12pt;" href="https://compasspathways.com/">Compass Pathways</a><span style="font-size: 12pt;">.</span></p></div><p><span style="font-size: 14pt;"><strong>Job overview:</strong></span><br><span style="font-size: 12pt;">The Senior Manager, Quality - GMP/GDP is responsible for supporting the business in all GMP/GDP related activities as related to commercial product.&nbsp;</span></p> <p><span style="font-size: 12pt;">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. </span></p> <p><span style="font-size: 12pt;">This role ensures seamless transition from development to commercial operations, with a strong focus on regulatory compliance, inspection readiness, and cross-functional alignment.</span></p> <p><span style="font-size: 14pt;"><strong>Reports to:</strong></span> <span style="font-size: 12pt;">Director, Product Quality.</span></p> <p><span style="font-size: 14pt;"><strong>Location:</strong></span> <span style="font-size: 12pt;">United Kingdom (Home-based or office-based/hybrid in our London office).</span></p> <p><strong><span style="font-size: 12pt;"><span style="font-size: 14pt;">Duration: </span></span></strong><span style="font-size: 12pt;">9-month contract.</span></p> <p><span style="font-size: 14pt;"><strong>Roles and responsibilities</strong>&nbsp;</span><br><span style="font-size: 14pt;"><em>(Include but are not limited to)</em>:&nbsp;</span></p> <p><span style="font-size: 12pt;"><strong>Commercial Readiness Planning</strong></span></p> <ul> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Execute Quality Commercial Readiness strategy for product launches</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Define readiness criteria across: </span> <ul> <li style="font-size: 12pt;"><span style="font-size: 12pt;">GMP (manufacturing, QC, release)</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">GDP (distribution, logistics, temperature control)</span></li> </ul> </li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Lead readiness assessments and track progress against milestones</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Ensure alignment with global regulatory requirements and expectations</span></li> </ul> <p><span style="font-size: 12pt;"><strong>GDP Readiness &amp; Distribution Oversight</strong></span></p> <ul> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Ensure distribution networks meet GDP standards:</span> <ul> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Warehousing</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Transportation</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Cold chain management</span></li> </ul> </li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Oversee qualification of: </span> <ul> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Logistics providers</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Distribution partners</span></li> </ul> </li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Ensure traceability, serialization, and product integrity requirements are met</span></li> </ul> <p><span style="font-size: 12pt;"><strong>Cross-Functional Collaboration</strong></span></p> <ul> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Partner with: </span> <ul> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Manufacturing &amp; Supply Chain</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Regulatory Affairs</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Technical Operations</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Commercial teams</span></li> </ul> </li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Ensure alignment on launch timelines and risk mitigation</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Serve as Quality SME for commercial readiness governance forums</span></li> </ul> <p><span style="font-size: 12pt;"><strong>Risk Management</strong></span></p> <ul> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Identify and manage risks impacting commercial readiness</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Implement mitigation strategies for:&nbsp;</span> <ul> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Supply disruptions</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Compliance gaps</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Process robustness</span></li> </ul> </li> </ul> <p><span style="font-size: 14pt;"><strong>Candidate Profile:</strong></span></p> <ul> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Education: Bachelor’s or master’s degree in: Pharmacy, Life Sciences, Engineering or related field</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Experience: 10+ years in Quality within Pharma / Biotech / Life Sciences</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Strong experience in: GMP and GDP regulations, Commercial product launches, Global regulatory interactions</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Technical Skills: Deep knowledge of EU GMP / FDA 21 CFR Parts 210/211 and GDP Guidelines (EU GDP 2013/C 343/01)</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Understanding of: Serialization and supply chain compliance, Validation lifecycle (IQ/OQ/PQ) and Familiarity with eQMS systems</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Leadership &amp; 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</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Preferred Experience: Experience in US product launches, Experience working with CMOs / CDMOs</span></li> </ul><div class="content-conclusion"><h2 style="line-height: 1;"><span style="font-size: 14pt;"><strong>Benefits &amp; Compensation:</strong></span></h2> <p style="line-height: 1;"><span style="font-size: 12pt;">For an overview of our benefits package and compensation information, please visit &nbsp;"<a href="https://compasspathways.com/join-us/">Working at Compass</a>". <strong>&nbsp;</strong></span></p> <h2 style="line-height: 1;"><span style="font-size: 14pt;"><strong>Equal opportunities:&nbsp;<br></strong></span></h2> <p style="line-height: 1.2;"><span style="font-size: 12pt;"><strong>Reasonable accommodation<br><br></strong>We are committed to building a workplace where everyone’s wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know.&nbsp;</span></p> <p style="line-height: 1;"><span style="font-size: 12pt;"><strong>UK applicants</strong></span></p> <p style="line-height: 1.2;"><span style="font-size: 12pt;">We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability.</span></p> <p style="line-height: 1;"><span style="font-size: 12pt;"><strong>US applicants</strong></span></p> <p style="line-height: 1.2;"><span style="font-size: 12pt;">Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law.</span></p> <h2 style="line-height: 1;"><strong><span style="font-size: 12pt;"><span style="font-size: 14pt;">Sponsorship</span>:</span></strong></h2> <p style="line-height: 1;"><span style="font-size: 12pt;">Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying.</span></p> <h2 style="line-height: 1;"><span style="font-size: 14pt;"><strong>Data Privacy:</strong></span></h2> <p style="line-height: 1;"><span style="font-size: 12pt;">All data is confidential and protected by all legal and data privacy requirements, please see our recruitment <a href="https://compasspathways.com/recruitment-candidates-privacy-notice/" target="_blank">Privacy Notice</a> to learn more about how we process personal data.</span></p></div>