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, and has offices in New York City and San Francisco in the US.  We focus on developing innovations that can improve the lives of those who are suffering with mental health challenges and who are not helped by current treatments. 

We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin (which has received breakthrough therapy designation from the FDA) is administered with psychological support. We are currently in phase 3 study for treatment-resistant depression (TRD), and phase 2 for both post-traumatic stress disorder and anorexia nervosa. Our vision is a world of mental wellbeing - Compass Pathways.

Job overview:  

Director, IT Validated Systems will play a crucial role in leading the management and validation of GxP-related systems to ensure compliance with regulatory standards. This role requires a strong leader with excellent communication skills, capable of prioritising and managing multiple projects effectively. The successful candidate will be responsible for ensuring the highest standards of quality and compliance across our operations. 

Location: Remote/Hybrid in the United Kingdom (preference for London) or on the East Coast, USA.

Report to: Vice President, IT.

Roles and responsibilities
(include but are not limited to): 

Leadership and Project Management:

  • Act as IT Business Partner to the Quality, Clinical, and Regulatory functions, as needed, to provide support for applications, maintain compliance within Compass policies and procedures, establish necessary service offerings, and roadmap budget for future capabilities
  • Take on the lead role in dealing with functional vendors/service providers, validation resources and associated contracts
  • Take a hands-on, high-communication approach to prioritise enterprise and operational projects
  • Identify resource and budget issues and collaborate with IT project managers to adjust projects based on company goals and IT budget constraints
  • Participate in the development and establishment of IT PMO procedures, dashboards, and reports
  • Provide clear recommendations to key stakeholders based on thorough analysis and best practice

Compliance and Risk Management:

  • Run a portfolio of compliance-related IT projects focused on maturing IT’s Risk-Based System Life Cycle (SDLC), GxP Compliance, Inspection Readiness, and Audit Operational Preparedness
  • Take ownership of, and manage the portfolio of GxP-related systems, ensuring their continued validated states
  • Perform retrospective compliance risk assessments on existing IT application and system portfolio, plan and execute any GxP qualification or validation required
  • Work with Business Partners and service providers to create necessary SOPs, policies and work instructions (WI)
  • Manage Configuration and Change Management, Periodic Review, Audit Trail and Access review, Periodic Restore, and Vendor Management processes for regulated systems
  • Represent the company’s IT department during FDA Pre-Approval Inspections (PAI) and other regulatory audits

 

Candidate Profile:

  • Bachelor’s degree in IT, Engineering, Computer Science, or a related field
  • Extensive experience in validation engineering within the biotechnology or pharmaceutical industry
  • Proven track record of leading and managing IT projects and teams
  • In-depth knowledge of GxP compliance, GAMP 5, FDA regulations, and risk-based system life cycle management
  • Strong problem-solving skills and the ability to adapt to changing priorities and deadlines
  • Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams
  • Aligned with our company mission and values of Compassionate, Bold, Rigorous and Inclusive 

【For NYC】Compensation Description (annually):

Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.

Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity.

【Base salary per annum】:
$180,000—$220,000 USD

Benefits & Compensation:

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

Equal opportunities: 

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, sexual 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, 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.

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.

Data Privacy:

All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

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At Compass Pathways, we embrace our colleagues' different abilities, sexual orientation/identification, ethnicity, faith, and gender. Everyone is welcome and supported in their development at all stages in their journey with us. We care about fostering this diversity and inclusion.

Therefore, we encourage all applicants to fill in the following questionnaire, which will help us with our active endeavours towards championing diversity and inclusion. Completion of the form is entirely voluntary. We do not discriminate based on any of these factors and any information provided on the following form is kept completely confidential; your interviewers will not see this. All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

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