Quality Manager, GMP posted about 2 months ago Psychedelic Alpha London, United Kingdom

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.

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):

• Act as a GMP Quality SME to support the business
• Provide GMP QA expertise to support commercial product
• Conduct gap analyses and drive closure of gaps in the QMS and support the business in doing the same
• Manage the PAI program and GMP inspection readiness at Compass and its vendors
• Lead investigations into significant quality issues, facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness
• Deputise for the Senior Quality Director, Manufacturing and Operations when required
• Provision of support to Quality Leaders as required
• 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 GMP and requirements that impact the QMS
• Measure and monitor the performance of the QMS
• 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
• A proven understanding of GMP and Quality Management requirements as applied in the industry
• Excellent 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 Sigma
• Demonstrated cross functional project management skills
• Excellent verbal and written communication skills, including the ability to interact effectively with different audiences
• Ability to understand quality issues in a complex 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
• Ability 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 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.

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