QMS Specialist

MoonLake Immunotherapeutics (NASDAQ: MLTX); Cambridge; Hybrid; GBP 30,000 - 60,000; Full time

Job description

Job Purpose

As a QMS Specialist you will maintain and develop the systems used within the MoonLake Development Quality Management System.

Key Accountabilities

1. Assist the QMS Manager in set-up, management and administration of the Quality Management Systems (QMS), ensuring compliance with relevant regulatory standards.
2. Manage the training tracking systems used within the Development Quality System, ensuring compliance with relevant regulatory standards.
3. Assist the MoonLake Quality Team and QMS users in recording and tracking of Quality related events (quality issues, CAPA, effectiveness checks, changes, audits and audit schedules).
4. Maintain and develop QMS tracking tools.
5. Work with other members of the MoonLake Quality Team, ensuring the timely and logical location and storage of GxP documentation.
6. As part of the Quality Team, ensure actions are communicated to client groups and progress tracked.
7. As part of the Development Quality team, develop the QMS tools to ensure ongoing efficient support to client groups.
8. Provide help and support to Development and Corporate staff using QMS tools e.g. Qualio.

Your profile
Experience

1. Some experience working within a “knowledge management” environment or equivalent where data management and metrics are key skills.

Skills/knowledge/behavioural Competencies

1. Highly developed interpersonal skills including communication and influencing skills.
2. Proven Word processing, Spreadsheet and data management skills.
3. Working knowledge of document/information management systems, e.g. SharePoint.
4. Highly organised self-motivator, able to prioritise activities, work well under pressure and meet deadlines.
5. Ability to find pragmatic solutions for quality issues in a highly agile environment.
6. The ability to interrogate and analyse systems.

Work Location:

1. 2 days a week in our brand new Cambridge or Porto Office(s).

Why us?
An exciting job opportunity awaits!
MoonLake is a dynamic and innovative company pushing the boundaries of possibility, and we are looking for passionate individuals to join our stellar team.

What We Offer
Learning Environment: An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment.
Impactful Work: Contribute to ground-breaking projects that have the potential to transform global healthcare.
Flexibility and Balance: Work remotely/hybrid, enjoying a healthy work-life balance while making meaningful contributions to our team.
Career Growth: A clear path for career progression, with the chance to take on more responsibilities as you develop your skills.
Our Core Values
We look for potential MoonLakers that embody our three core values that drive our pursuit of excellence:
We do Stellar Science: We aspire to create novel therapies that elevate treatment horizons, with innovative science, and high quality, always.
We go beyond: We aspire to be positively disruptive in our field, and bold in the way we challenge the norms and each other.
We unlock value: We aspire to create long-term value for investors and communities.
About Us
MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody for the treatment of the inflammatory disease, to revolutionize outcomes for patients.
We continue to make significant progress in our Global Clinical Development Programs. The company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquartered in Zug, with hubs in Cambridge & Porto.
Further information is available at www.moonlaketx.com