Senior Quality Expert

6 months ago

Cambridge, United Kingdom MoonLake Immunotherapeutics Full time

**Job Purpose**:
**As a Senior Quality Expert (GCP), you will support senior management in ensuring Quality is at the heart of all company initiatives and, specifically, you will act as advisor to the Clinical Development teams on all quality related GCP activities.**
**Key accountabilities**:

- To play a key role in maintaining and monitoring the GxP Quality Management System (QMS)
- To ensure that the QMS meets all necessary regulatory requirements, including good-practice guidelines and standards, with specific emphasis on GCP compliance.
- To provide support and advice to Clinical Development teams with regards to:

- Definition of appropriate compliant procedures within GxP functions
- Management of quality issues
- To ensure external contracted organisations supporting GxP activities are selected and responsibilities defined and documented.
- To monitor the performance of GxP service providers with regards to the relevant quality standards.
- To define and manage clinical audit programme.
- To perform GCP audits if required (for example audits to be conducted at short notice).
- Maintain agreed quality metrics and dashboards to enable clear communication to senior management of compliance performance and any risks or issues identified.
- To maintain awareness of, and ensure compliance with, policies and procedures relating to quality standards within the Company.

**Your profile**:
**Education**: Scientific degree (ideally pharmaceutical science, Biology, chemistry or related)
**Experience**: Minimum 5+ years in a similar role

**Skills/Knowledge/Behavioural Competencies**:

- Substantial experience of successfully managing quality issues in a biotechnology or biopharmaceutical environment
- Proven track record in defining, implementing and maintaining Quality Management Systems for biotechnology or biopharmaceutical companies
- Proven track record of monitoring and influencing the quality performance of internal functions and contracted service providers, including self-inspection and external audit experience
- Comprehensive knowledge of GCP requirements as applied to biologics and related industry/regulatory guidelines governing clinical trials in the EU & USA
- Basic understanding of GLP and GMP requirements for biologics
- Strong communication, negotiation and influencing skills
- Strong conflict resolution abilities
- Basic Knowledge of GLP and cGMP and related industry/regulatory guidelines governing the manufacture of biologics in the UK, EU & US
- Ability to work in a flexible, collaborative style with colleagues and teams within the company and with external entities including CROs and consultants.
- Highly organised self-motivator, able to prioritise activities, work well under pressure and meet deadlines
- Ability to find pragmatic solutions for quality issues in a highly agile biotech environment

**Work Location**:

- 2 days a week in our brand new office in Porto or Cambridge with some travel

**Why us?**:
**An exciting job opportunity awaits you**

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 groundbreaking 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 headquarted in Zug, with hubs in Cambridge & Porto.

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