Quality Manager, GMP

1 week ago

London, Greater London, United Kingdom Compass Pathways Full time £60,000 - £100,000 per year

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 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:  

The GMP Quality Manager is responsible to support the business in all GMP related activities as related to commercial product. This role will act as a GMP advisor for the whole of Compass and will incorporate requirements of QMS and vendor oversight. The Quality Manager will deputise for the Senior Quality Director, Manufacturing and Operations.

Location: Hybrid in our London office or remote in the United Kingdom.

Reports to: Senior Director, Quality Operations.

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

Quality SME 

Act as a GMP Quality SME to support the businessProvide GMP QA expertise to support commercial productConduct gap analyses and drive closure of gaps in the QMS and support the business in doing the sameManage the PAI program and GMP inspection readiness at Compass and its vendorsLead investigations into significant quality issues, facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness 

Quality Leadership

Deputise for the Senior Quality Director, Manufacturing and Operations when requiredProvision of support to Quality Leaders as required 

QMS

Ensure that company Quality related processes are harmonised and standardised to drive compliance and improve efficiencyResponsible to keep up to date with current and evolving regulatory requirements, including changes relating to GMP and requirements that impact the QMSMeasure and monitor the performance of the QMS

Quality Risk Management

Make Risk based Quality decisionsIdentify, assess, prioritise and address risks and opportunitiesInvestigate non-conformances effectively and manage risks

Candidate Profile:

Broad based knowledge of the pharmaceutical industry at least 10 years' experience in the industryScientific/engineering degree or equivalent combination of education and experienceA proven understanding of GMP and Quality Management requirements as applied in the industryExcellent understanding of and a passion for continuous improvement in a pharmaceutical environment, with experience applying techniques such as RCA root-cause analysis, CAPA, Lean, Six SigmaDemonstrated cross functional project management skillsExcellent verbal and written communication skills, including the ability to interact effectively with different audiencesAbility to understand quality issues in a complex a highly regulated environment and make data driven recommendation/decisions and take appropriate actionGood knowledge of GxP and pharmaceutical regulationsAbility to influence and challenge others in a constructive wayAbility to prioritise tasks and deliver against milestones in a fast-paced environment 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 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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