Director, Product Quality
Compass Pathways, Palm Coast, FL, United States
Company Introduction
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 U.S. Food and Drug Administration and has received Innovative Licensing and Access Pathway designation in the U.K. for treatment‑resistant depression.
We are currently in phase 3 for TRD, have completed phase 2 studies for 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.
Job Overview This role focuses on providing strategic direction for Compass product manufacture and distribution through strategic partnership development internally and with external partners.
It ensures quality strategies for Compass operations and product lifecycle alignment with GMP/GDP requirements, and guides the QMS to adapt to changing business needs, company goals and GxP regulatory requirements.
Location Hybrid in our New York City office or remote on the East Coast, USA.
Reports to Vice President, Quality.
Roles and Responsibilities QA Expertise
Maintain oversight of current and evolving global regulatory requirements, proactively assessing impact to Compass products and developing remediation plans where required.
Provide subject‑matter expertise in GMP and GDP, ensuring consistent application across internal and external operations.
Leadership
Drive enterprise quality strategy across Supply Chain, Manufacturing, and QMS to reduce operational risk, optimise performance, and support growth and transformation.
Lead, develop, and coach the Product Quality team, building strong capability and enabling effective quality partnerships across the organisation.
Act as the primary quality point of contact for Compass Supply and Contract Manufacturing Organisations (CMOs).
Provide quality support and oversight for Manufacturing and Supply, spanning both IMP and commercial supply chains.
Deputise for VP, Quality when required.
Product Quality Management
Define and implement phase‑appropriate ways of working with external partners, ensuring alignment with Compass strategies and regulatory expectations.
Manage all quality aspects of commercial readiness activities, within Compass and across the extended supply chain.
Drive strong, collaborative quality relationships with CMOs, ensuring alignment with Compass QMS requirements and commercialisation objectives.
Build a robust and resilient supply chain while ensuring compliant, cost‑effective processes that support profitable growth.
Provide strategic quality direction to support dual supply for clinical (IMP) supply and a fully commercial supply chain.
Candidate Profile
Broad knowledge of the pharmaceutical industry and at least 12 years’ experience, with 7 at a managerial level.
Scientific/engineering degree or equivalent combination of education and experience.
Postgraduate qualification in Quality Management or equivalent.
Proven understanding of GMP, GCP, pharmacovigilance and quality management requirements.
Excellent understanding of continuous improvement in a pharmaceutical environment.
Passion for continuous improvement and experience applying techniques such as RCA, CAPA, Lean, Six Sigma.
Ability to identify appropriate KPIs, implement them as control mechanisms, and drive change and improvement.
Extensive experience establishing and leading QMS systems and processes in a highly regulated environment across multiple sites, GxPs and locations.
Proven ability to present effectively to all levels of an organisation, including project rationale and updates, and strategic plans.
Ability to build effective relationships (internal and external).
Excellent verbal and written communication skills, including the ability to interact effectively with different audiences.
Excellent networking skills with the ability to collaborate and agree outcomes.
Ability to understand quality issues in a complex, highly regulated environment and make data‑driven recommendations/decisions and take appropriate action.
Proven record of leading management and staff to deliver business plans.
Compensation Base pay: $180,000—$240,000 USD per annum.
Base pay is part of the total package that may include discretionary bonuses and equity.
Benefits & Compensation Further details on benefits and compensation are available internally.
Equal Opportunities & Reasonable Accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process, please let our recruiting team know.
UK Applicants We maintain a commitment to diversity and equality under the Equality Act 2010. No discrimination on race, religion or belief, colour, nationality, ethnicity or national origin, gender, pregnancy or maternity, marital or civil partnership status, sexual orientation, gender reassignment, age or disability.
US Applicants Compass Pathways is an equal‑opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to protected characteristics defined by applicable law.
Sponsorship We cannot sponsor employment visas and only accept applications from candidates with employment rights in the country to which they are applying.
Data Privacy All data is confidential and protected by legal and data privacy requirements. Please see the recruitment privacy notice for details on how we process personal data.
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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 U.S. Food and Drug Administration and has received Innovative Licensing and Access Pathway designation in the U.K. for treatment‑resistant depression.
We are currently in phase 3 for TRD, have completed phase 2 studies for 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.
Job Overview This role focuses on providing strategic direction for Compass product manufacture and distribution through strategic partnership development internally and with external partners.
It ensures quality strategies for Compass operations and product lifecycle alignment with GMP/GDP requirements, and guides the QMS to adapt to changing business needs, company goals and GxP regulatory requirements.
Location Hybrid in our New York City office or remote on the East Coast, USA.
Reports to Vice President, Quality.
Roles and Responsibilities QA Expertise
Maintain oversight of current and evolving global regulatory requirements, proactively assessing impact to Compass products and developing remediation plans where required.
Provide subject‑matter expertise in GMP and GDP, ensuring consistent application across internal and external operations.
Leadership
Drive enterprise quality strategy across Supply Chain, Manufacturing, and QMS to reduce operational risk, optimise performance, and support growth and transformation.
Lead, develop, and coach the Product Quality team, building strong capability and enabling effective quality partnerships across the organisation.
Act as the primary quality point of contact for Compass Supply and Contract Manufacturing Organisations (CMOs).
Provide quality support and oversight for Manufacturing and Supply, spanning both IMP and commercial supply chains.
Deputise for VP, Quality when required.
Product Quality Management
Define and implement phase‑appropriate ways of working with external partners, ensuring alignment with Compass strategies and regulatory expectations.
Manage all quality aspects of commercial readiness activities, within Compass and across the extended supply chain.
Drive strong, collaborative quality relationships with CMOs, ensuring alignment with Compass QMS requirements and commercialisation objectives.
Build a robust and resilient supply chain while ensuring compliant, cost‑effective processes that support profitable growth.
Provide strategic quality direction to support dual supply for clinical (IMP) supply and a fully commercial supply chain.
Candidate Profile
Broad knowledge of the pharmaceutical industry and at least 12 years’ experience, with 7 at a managerial level.
Scientific/engineering degree or equivalent combination of education and experience.
Postgraduate qualification in Quality Management or equivalent.
Proven understanding of GMP, GCP, pharmacovigilance and quality management requirements.
Excellent understanding of continuous improvement in a pharmaceutical environment.
Passion for continuous improvement and experience applying techniques such as RCA, CAPA, Lean, Six Sigma.
Ability to identify appropriate KPIs, implement them as control mechanisms, and drive change and improvement.
Extensive experience establishing and leading QMS systems and processes in a highly regulated environment across multiple sites, GxPs and locations.
Proven ability to present effectively to all levels of an organisation, including project rationale and updates, and strategic plans.
Ability to build effective relationships (internal and external).
Excellent verbal and written communication skills, including the ability to interact effectively with different audiences.
Excellent networking skills with the ability to collaborate and agree outcomes.
Ability to understand quality issues in a complex, highly regulated environment and make data‑driven recommendations/decisions and take appropriate action.
Proven record of leading management and staff to deliver business plans.
Compensation Base pay: $180,000—$240,000 USD per annum.
Base pay is part of the total package that may include discretionary bonuses and equity.
Benefits & Compensation Further details on benefits and compensation are available internally.
Equal Opportunities & Reasonable Accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process, please let our recruiting team know.
UK Applicants We maintain a commitment to diversity and equality under the Equality Act 2010. No discrimination on race, religion or belief, colour, nationality, ethnicity or national origin, gender, pregnancy or maternity, marital or civil partnership status, sexual orientation, gender reassignment, age or disability.
US Applicants Compass Pathways is an equal‑opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to protected characteristics defined by applicable law.
Sponsorship We cannot sponsor employment visas and only accept applications from candidates with employment rights in the country to which they are applying.
Data Privacy All data is confidential and protected by legal and data privacy requirements. Please see the recruitment privacy notice for details on how we process personal data.
#J-18808-Ljbffr