Director, Product Quality

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 notWe 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:

This role focuses on providing strategic direction for Compass product manufacture and distribution through strategic partnership development internally and with external partners.

Ensures that quality strategies for Compass operations and ensures that throughout product lifecycle for all Compass products to align with GMP / GDP requirements. As well as strategic Quality direction for Compass QMS to ensure that processes adapt to changing business needs, company goals and addresses 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
(Include but are not limited to):

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 the Compass business through growth and transformation

Lead, develop, and coach the Product Quality team, building strong Quality 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

Deputize 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 based knowledge of the pharmaceutical industry at least 12 years' experience in the industry of which 7 should be at a managerial level.

Scientific/engineering degree or equivalent combination of education and experience

Postgraduate qualification in Quality Management or equivalent combination of education and experience

A proven understanding of GMP, GCP, Pharmacovigilance and Quality Management requirements as applied in the industry

Excellent understanding of continuous improvement in a pharmaceutical environment

A passion for continuous improvement and experience applying techniques such as RCA root-cause analysis, CAPA, Lean, Six Sigma

Ability to identify appropriate KPI's, implement and use as control mechanisms and drive change and improvement

Extensive experience of establishing and leading the QMS system and process, in a highly regulated environment across multiple sites, GxPs and locations

Proven ability to present effectively to all levels of an organisation to include project rationale and updates, 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 networker with the ability to collaborate and agree outcomes

Ability to understand quality issues in a complex a highly regulated environment and make data driven recommendation/decisions and take appropriate action

Proven record of leading management and staff to deliver business plans

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

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 to be at your best, please let our recruiting team know.

UK applicants

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, ****** orientation, gender reassignment, age or disability.

US applicants

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, *** (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, ****** orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law.

Sponsorship:
Unfortunately, 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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