COMPASS Pathways plc is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health (https://compasspathways.com/).
Our first major initiative is developing psilocybin therapy for patients with treatment-resistant depression, using our COMP360 psilocybin in conjunction with psychological support; we are in the final stages of a large-scale, international phase IIb clinical trial. At the same time, our Preclinical team is busy building a comprehensive R&D portfolio with new compounds and indications, focused on our Discovery Center in the US, and in collaboration with partners all over the world.
Directs design and implementation an agile efficient Quality Management System (QMS) across the Compass Pathways organisation aligned to company goals and regulatory requirements. Provides strategic direction to ensure that the QMS adapts to changing business needs and addresses all GxP regulatory requirements from R&D through to commercialisation in line with Quality strategy.
Location: United Kingdom (Home-based considered).
Reports to: The Director of Quality Operations will report to the Head of Quality GxP.
Roles and responsibilities:
- Lead the design, development and maintenance of a fully compliant agile QMS that meets business and regulatory expectations
- Develop strategies to ensure the QMS continues to align with current and future business systems
- Ensure that company Quality related processes are harmonised and standardised to drive compliance and improve efficiency
- Business ownership of the QMS systems, processes and results
- Accountable to implement, maintain a ‘fit for purpose’ electronic QMS that is sustainable and adapts to changing business needs across the organisation
- Responsible to keep up to date with current and evolving regulatory requirements, including changes relating to GxP, digital and medical device requirements. that impact the QMS
- Provides Quality leadership to the Compass business as it affects the QMS to ensure the QMS remains fit for purpose
- Report to senior management at Chief officer, senior leadership and VP level on the performance of the quality KPIs that reflect the effectiveness of the QMS
- Maintain awareness of customer requirements throughout the organisation and ensure these are supported by the QMS
- Lead implementation of SOP and GxP training program
- Implement Quality Champion network to ensure Quality embedded across the organisation
- Direct the QMS team to ensure provision of a first-class service to both internal and external customers of the QMS
- Broad based knowledge of the pharmaceutical and medical device 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 GDP, GCP, Pharmacovigilance and ISO 13485 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
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.