At a Glance
- Tasks: Lead quality assurance for innovative mental health treatments and ensure compliance with industry standards.
- Company: Join Compass Pathways, a pioneering biotech firm transforming mental health care.
- Benefits: Enjoy competitive pay, flexible working options, and a commitment to your wellbeing.
- Other info: Work in a supportive culture that values diversity and equality.
- Why this job: Make a real difference in mental health while advancing your career in a dynamic environment.
- Qualifications: 10+ years in Quality within Pharma/Biotech and strong knowledge of GMP/GDP regulations.
The predicted salary is between 60000 - 80000 € 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.
Job overview: The Senior Manager, Quality - GMP/GDP is responsible for supporting the business in all GMP/GDP related activities as related to commercial product. This position is responsible for ensuring that products, processes, systems, and supply chains are fully compliant and inspection-ready to support successful commercial launch and ongoing distribution in line with GMP and GDP requirements. This role ensures seamless transition from development to commercial operations, with a strong focus on regulatory compliance, inspection readiness, and cross-functional alignment.
Reports to: Director, Product Quality.
Location: United Kingdom (Home-based or office-based/hybrid in our London office).
Duration: 9-month contract.
Roles and responsibilities (Include but are not limited to):
- Commercial Readiness Planning
- Execute Quality Commercial Readiness strategy for product launches
- Define readiness criteria across:
- GMP (manufacturing, QC, release)
- GDP (distribution, logistics, temperature control)
- Lead readiness assessments and track progress against milestones
- Ensure alignment with global regulatory requirements and expectations
- GDP Readiness & Distribution Oversight
- Ensure distribution networks meet GDP standards:
- Warehousing
- Transportation
- Cold chain management
- Oversee qualification of:
- Logistics providers
- Distribution partners
- Ensure traceability, serialization, and product integrity requirements are met
- Cross-Functional Collaboration
- Partner with:
- Manufacturing & Supply Chain
- Regulatory Affairs
- Technical Operations
- Commercial teams
- Ensure alignment on launch timelines and risk mitigation
- Serve as Quality SME for commercial readiness governance forums
- Risk Management
- Identify and manage risks impacting commercial readiness
- Implement mitigation strategies for:
- Supply disruptions
- Compliance gaps
- Process robustness
Candidate Profile:
- Education: Bachelor’s or master’s degree in: Pharmacy, Life Sciences, Engineering or related field
- Experience: 10+ years in Quality within Pharma / Biotech / Life Sciences
- Strong experience in: GMP and GDP regulations, Commercial product launches, Global regulatory interactions
- Technical Skills: Deep knowledge of EU GMP / FDA 21 CFR Parts 210/211 and GDP Guidelines (EU GDP 2013/C 343/01)
- Understanding of: Serialization and supply chain compliance, Validation lifecycle (IQ/OQ/PQ) and Familiarity with eQMS systems
- Leadership & Behavioural Competencies: Strong leadership and stakeholder management skills, Ability to operate in high-pressure, launch-driven environments, Excellent problem-solving and risk management capability, Strong communication and influencing skills, Strategic mindset with attention to operational detail
- Preferred Experience: Experience in US product launches, Experience working with CMOs / CDMOs
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.
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.
Senior Manager, Quality - GMP/GDP (Contract) in London employer: Compass Pathways
Compass Pathways plc is an exceptional employer, offering a dynamic work environment that prioritises innovation in mental health treatment. With a strong commitment to employee wellbeing and professional growth, the company fosters a collaborative culture where every team member can contribute to meaningful advancements in healthcare. Located in London, employees benefit from a vibrant city atmosphere while engaging in groundbreaking projects that aim to transform lives.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager, Quality - GMP/GDP (Contract) in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the biotech and pharma sectors. Attend industry events or webinars, and don’t be shy about introducing yourself. You never know who might have the inside scoop on job openings at Compass Pathways.
✨Tip Number 2
Prepare for interviews by diving deep into Compass Pathways’ mission and values. Understand their innovative approach to mental health treatments. This will not only help you answer questions but also show your genuine interest in the company’s work.
✨Tip Number 3
Showcase your expertise in GMP and GDP during interviews. Be ready to discuss specific examples from your past experiences that highlight your compliance knowledge and problem-solving skills. This is your chance to shine!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re serious about joining the team at Compass Pathways and contributing to their groundbreaking work in mental health.
We think you need these skills to ace Senior Manager, Quality - GMP/GDP (Contract) in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior Manager, Quality role. Highlight your experience with GMP and GDP regulations, as well as any relevant product launch successes. We want to see how your background aligns with our mission at Compass Pathways!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about mental health innovation and how your skills can contribute to our goals. Keep it concise but impactful – we love a good story!
Showcase Your Leadership Skills:In your application, don’t forget to highlight your leadership and stakeholder management experience. We’re looking for someone who can thrive in high-pressure environments, so share examples of how you've successfully led teams or projects in the past.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re serious about joining our team at Compass Pathways!
How to prepare for a job interview at Compass Pathways
✨Know Your GMP and GDP Inside Out
Make sure you brush up on your knowledge of GMP and GDP regulations. Be prepared to discuss how these standards apply to commercial product launches and what steps you've taken in previous roles to ensure compliance. This will show that you're not just familiar with the terms, but that you can actively contribute to the company's quality assurance efforts.
✨Demonstrate Cross-Functional Collaboration Skills
Since this role involves working closely with various teams, think of examples from your past where you successfully collaborated across departments. Highlight how you managed to align different stakeholders on project timelines and risk mitigation strategies. This will illustrate your ability to work in a team-oriented environment, which is crucial for success at Compass Pathways.
✨Prepare for Risk Management Scenarios
Be ready to discuss specific instances where you identified risks in a project and how you implemented mitigation strategies. Compass Pathways is looking for someone who can handle high-pressure situations, so showcasing your problem-solving skills in real-world scenarios will set you apart from other candidates.
✨Show Your Passion for Mental Health Innovation
Compass Pathways is dedicated to improving mental health treatments, so it’s important to convey your enthusiasm for this mission. Research their investigational COMP360 treatment and be prepared to discuss how your background aligns with their goals. This will demonstrate that you’re not just looking for a job, but that you genuinely care about making a difference in the field.
