At a Glance
- Tasks: Lead quality assurance for innovative mental health products and ensure compliance with regulations.
- Company: Join a pioneering biotech company focused on transforming mental health treatment.
- Benefits: Flexible working options, competitive pay, and a commitment to employee wellbeing.
- Other info: Opportunity for growth in a supportive and diverse workplace.
- 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.
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, US. It focuses on developing treatment options that could improve the lives of those suffering with mental health conditions and who are not helped by current treatments.
The Senior Manager, Quality - GMP/GDP supports all GMP/GDP-related activities for commercial products, ensuring that products, processes, systems and supply chains are compliant and inspection-ready for launch and ongoing distribution. The role bridges development and commercial operations, focusing on regulatory compliance, inspection readiness and cross-functional alignment.
Roles and responsibilities
- Commercial Readiness Planning
- Execute Quality Commercial Readiness strategy for product launches
- Define readiness criteria across GMP (manufacturing, QC, release) and 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
- Warehouse oversight
- Transportation management
- Cold‑chain management
- Oversee qualification of logistics providers and distribution partners
- Ensure traceability, serialization and product integrity requirements are met
- Cross‑Functional Collaboration
- Partner with manufacturing & supply chain, regulatory affairs, technical operations and commercial teams
- Align on launch timelines and risk mitigation
- Serve as Quality SME for commercial readiness governance forums
- Identify and manage risks impacting commercial readiness (supply disruptions, compliance gaps, process robustness)
Candidate profile
- Education: Bachelor’s or master’s degree in Pharmacy, Life Sciences, Engineering or a related field
- Experience: 10+ years in Quality within Pharma/Biotech/Life Sciences
- Technical skills: Deep knowledge of EU GMP / FDA 21 CFR Parts 210/211 and GDP Guidelines (EU GDP 2013/C 343/01), 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: US product launches, working with CMOs/CDMOs
Benefits & Compensation
For an overview of our benefits package and compensation information, please visit “Working at Compass”.
Equal opportunities & diversity
We are committed to building a workplace where everyone’s wellbeing matters. UK and US applicants are welcome to request reasonable accommodation. Compass Pathways proudly supports diversity and equality under the Equality Act 2010 (UK) and relevant U.S. laws.
Sponsorship
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 legal and data privacy requirements. Please see our recruitment Privacy Notice for further information.
Contact & application
Please submit your application through our online portal.
Senior Manager, Quality - GMP/GDP (Contract) employer: Compass Pathways
Compass Pathways plc is an exceptional employer, offering a dynamic work environment in the heart of London, where innovation in mental health treatment is at the forefront. With a strong commitment to employee wellbeing and professional growth, the company fosters a culture of collaboration and inclusivity, providing opportunities for meaningful contributions to life-changing projects. Employees benefit from a comprehensive package that supports both personal and professional development, making it an ideal place for those looking to make a significant impact in the biotech industry.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager, Quality - GMP/GDP (Contract)
✨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!
✨Tip Number 2
Prepare for interviews by researching Compass Pathways and their recent projects. Show them you’re not just another candidate; you’re genuinely interested in their mission to improve mental health treatments. Tailor your answers to reflect their values and goals.
✨Tip Number 3
Practice your STAR technique for behavioural questions. Think of specific situations where you demonstrated leadership or problem-solving skills, especially in high-pressure environments. This will help you stand out as a strong candidate for the Senior Manager role.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re serious about joining the team at Compass Pathways. Let’s get you that interview!
We think you need these skills to ace Senior Manager, Quality - GMP/GDP (Contract)
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior Manager, Quality role. Highlight your experience in GMP and GDP regulations, and any relevant commercial product launches. We want to see how your background aligns with what we're looking for!
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 mission at Compass Pathways. Keep it concise but impactful!
Showcase Your Leadership Skills:In your application, don’t forget to highlight your leadership and stakeholder management skills. We’re looking for someone who can thrive in high-pressure environments, so share examples of how you've successfully led teams or projects.
Apply Through Our Website:We encourage you to submit your application through our online portal. It’s the easiest way for us to review your materials and get back to you. Plus, it shows you’re serious about joining our team!
How to prepare for a job interview at Compass Pathways
✨Know Your GMP/GDP Inside Out
Make sure you brush up on your knowledge of GMP and GDP regulations. Be prepared to discuss how these regulations impact commercial product launches and what specific compliance measures you've implemented in past roles.
✨Showcase Your Cross-Functional Collaboration Skills
This role requires working closely with various teams. Think of examples where you've successfully collaborated with manufacturing, regulatory affairs, or supply chain teams. Highlight your ability to align on timelines and manage risks effectively.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in high-pressure situations. Prepare scenarios where you've had to manage compliance gaps or supply disruptions, and be ready to explain your thought process and the outcomes.
✨Demonstrate Your Leadership Style
As a Senior Manager, you'll need strong leadership skills. Be ready to discuss your leadership style and provide examples of how you've influenced stakeholders and driven quality initiatives in previous roles.
