Quality Manager

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:

The Quality Manager will support the Quality team through having oversight of the QMS and support on Quality Operations by measuring performance across the business and KPI's. They oversee the audit program, ensuring delivery is in line with the audit strategy. The Quality Manager will support Quality Culture initiatives by engaging cross-functionally.

Location: Home-based in the United Kingdom or hybrid/office-based in our London office.

Reports to: The QA Manager will report into the Quality Director, Manufacturing and Operations.

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

• Quality Management System
• Measure and monitor the performance of the audit program and other QMS KPIs
• Generate and report KPI Weekly / monthly to internal business partners and Quality Council
• Track critical CAPA in the QMS to ensure delivery and reporting
• Act as a MasterControl superuser and owner of the QMS
• Present Quality metrics and escalate systemic and/or critical problems to management
• Quality SME
• Act as a Quality SME to support the business where required
• Training package creation and reviews
• Process flow design and reviews
• Lead investigations into significant quality issues, facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness
• Provision of support to Quality Leaders as required
• Audit Management
• Review of audit reports for consistency prior to upload to MasterControl
• Co-ordination of auditor's contracts, agreements, and POs with legal and R&D operations
• Co-ordination and tracking of auditor qualification records

Candidate Profile:

• QA professional with broad drug experience
• Demonstrated auditing experience across all GxP (especially GCP)
• Understanding of international regulations with a focus on FDA & EMA regulations
• Excellent interpersonal, verbal, and written communication skills with the ability to diplomatically address quality issues
• Experience with GXP QA systems, processes, and procedures such as documentation and record management, change control, deviations, investigations, training, audit and CAPA.
• Bachelor's degree in a scientific discipline is required or equivalent combination of education and experience
• Considerable level of relevant experience in a GMP and/or GCP biotech/pharmaceutical setting
• Results oriented, establishing clear expectations and priorities. Consistently delivers
• Flexible and creative problem-solving skills; ability to challenge current processes, practices and strategy and uncover alternative approaches, solutions, or methods
• Collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders and who is enthusiastic and willing collaborate with other QA Leaders
• Excellent verbal and written communication skills, including the ability to interact effectively with different audiences
• Experience in process improvement and knowledge of lean principles

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

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.

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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