Disruptive
Care
Consumer
Connection &Quality Manager
COMPASS Pathways
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:
The Quality Manager is responsible to support manufacturing and to advise on vendor onboarding, technical transfer and validation.
This role will act as a GMP/GDP advisor to the manufacturing and supply team for activities in the US. This role will also provide operational Quality support through QMS oversight and record management.
Location: Hybrid in our New York City office or Remote in the United States.
Reports to: Quality Director, Manufacturing and Operations.
Roles and responsibilities
(Include but are not limited to):
- Operational Quality Support
- Act as Quality point of contact for US GMP/GDP vendors and ensure requirements within QTA’s are maintained with partners
- Quality oversight of GXP vendor qualification, process analytical and shipping validation, non-conformances and changes at vendors
- Quality oversight of technical transfer and validation activities at partners
- QMS
- Ensure that company Quality related processes are harmonised and standardised to drive compliance and improve efficiency
- Responsible to keep up to date with current and evolving regulatory requirements, including changes relating to GxP and requirements that impact the QMS
- Measure and monitor the performance of the QMS
- 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
- 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
- Quality Risk Management
- Make Risk based Quality decisions
- Identify, assess, prioritise and address risks and opportunities
- Investigate non-conformances effectively and manage risks
Candidate Profile:
- Broad based knowledge of the pharmaceutical industry at least 10 years’ experience in the industry
- 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 GxP and Quality Management requirements as applied in the industry
- Excellent understanding of continuous improvement in a pharmaceutical environment, with 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.
- Excellent verbal and written communication skills, including the ability to interact effectively with different audiences.
- Ability to understand quality issues in a complex a highly regulated environment and make data driven recommendation/decisions and take appropriate action.
- Good knowledge of GxP and pharmaceutical regulations
- Ability to influence and challenge others in a constructive way
- Good at prioritising tasks and delivering against milestones in a fast-paced environment
- Alignment to our company values
【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.
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.