COMPASS Pathways is looking for Quality Officer to work as a subject matter expert in set up and implementation of the MasterControl Quality suite in Compass. They will be responsible for representing the business needs during implementation of the MasterControl. They will also provide ongoing support for the current QMS.
COMPASS Pathways plc is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving 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 therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support.
COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. We are also running a phase II clinical trial of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD). COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing. www.compasspathways.com.
Reports to: The Quality Operations Director.
Location: United Kingdom (with partial office attendance).
Type of contract: Full time, temporary contract for 6 months (with potential to turn into a permanent employment).
Roles and responsibilities
Responsibilities include (but are not limited to):
- Participate in workshops that ensure the system is set up and operates in line with business needs
- Administration of SOPs, QE and CAPA tracking and reporting
- PQ testing and validation
- Update of QMS procedures in line with changes required to implement Master Control
- Proven industry experience in the pharmaceutical and/or medical device industry.
- A working knowledge and practical experience with implementing and managing/maintaining electronic QMS with an understanding of regulatory requirements.
- Experience using and administering Master Control
- Knowledge and application of the requirements for Computer Systems Validation including the regulatory requirements (21.CFR.11) for use of electronic signatures and GAMP regulations
- An inquiring mind and great enthusiasm to work in an exciting and fast-moving environment
- Excellent computer skills and great attention to detail
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.