Senior Manager Quality GCP Compliance

Overview

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Senior Manager Quality GCP Compliance

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MoonLake Immunotherapeutics (NASDAQ: MLTX) .Direct message the job poster from MoonLake Immunotherapeutics (NASDAQ: MLTX).Job Purpose

As the Senior Manager Quality GCP Compliance, you will ensure robust GCP quality oversight across MoonLake’s clinical programs and vendors by providing expert guidance, leading audit and inspection readiness activities, and supporting continuous compliance with regulatory standards.Your responsibilities

Support implementation and delivery of GCP Quality oversight requirements within MoonLake and our vendors, including taking part in internal, vendor and clinical site audits as necessary.Serve as GCP Subject Matter Expert, providing independent quality guidance to assigned clinical trial teams (acting as sponsor Quality Representative).Attend clinical meetings (internal and external) and provide Quality Representation on assigned clinical trials, ongoing review of quality and compliance risks including deviations, trends, cross-programme risks, clinical trial audit trending, etc.Act as GCP QA lead for Quality Issues, CAPAs, and CAPA effectiveness checks for assigned clinical programmes/trials, and working with Owners and counterpart CRO leads to resolution.Development and management of clinical trial audits and management of audits assigned to audit vendor.Ensure that Director, GCP and Associate VP, Quality are kept informed of progress, highlighting successes as well as potential issues on clinical programmes or MoonLake Quality management system activities.Working with the broader Quality Team, provide input to the development of the MoonLake Quality Systems, ensuring they meet GCP requirements relevant to the phase of development (including Quality Document reviews, computer system validation deliverables, etc.).Support GCP inspection readiness activities and management of regulatory inspections of MoonLake (e.g. mock inspection activities, dossier preparations, front room and backroom activities, etc.).Collaborate and information sharing within GCP team to ensure ongoing oversight of all GCP activities within and subcontracted by MoonLake.Provide training, advice, and guidance to staff on regulatory GCP compliance matters and continuous quality improvement initiatives.Maintain awareness of, and ensure compliance with, policies and procedures relating to quality standards within the Company.Your profile

Education

Bachelor’s degree in life science or healthcare field required. Advanced degree or equivalent education/degree in life sciences/healthcare preferred (PhD/MD/PharmD/Masters) desirable.Experience

Comprehensive (8+ years) experience in Clinical Quality Assurance and/or Clinical Operations with knowledge of Good Clinical Practice (GCP) across all phases of clinical development (phase 1-3).Conducting GCP clinical audits (investigator site audits, GCP vendor audits, process/system audits during end-to-end clinical trial lifecycle).Knowledge of marketing authorization application activities desirable.Strong familiarity with GCP requirements in USA, EU, UK and experience with global clinical trials.Supporting GCP inspection readiness activities and hosting regulatory GCP inspections (FDA, MHRA, EMA).Delivering risk-based audit programmes (clinical trial, internal and external).Monitoring risk assessment of relevant indicators/metrics/thresholds to detect potential issues, early signals or trends of risks at clinical study or programme level.Experience in project management and independently working on Quality process improvements as well as part of a team.Authorship, review and approval of Policies, SOPs, and Working Instructions.Quality oversight of clinical trials from protocol development to clinical study reporting.Experience with electronic Quality Management Systems and development of electronic systems to support clinical trial activities and Quality initiatives.Highly developed communication, negotiation and influencing skills; conflict resolution abilities.Demonstrates in-depth knowledge of GCP and GCLP and regulatory guidelines for clinical trials in the EU and USA as applied to late-stage product development and licensure.Some knowledge of other GxPs, including GMP, as applied to clinical development is an advantage.Critical thinking, risk management and risk-based mindset.Ability to communicate with staff at all levels up to executive level; ability to work in a flexible, collaborative style with internal teams and external CROs/consultants.Highly organised, able to prioritise, work under pressure and meet deadlines; strong decision-making in ambiguity; ability to find pragmatic solutions in a dynamic biotech environment.Ability to lead quality improvements and ensure quality issues are resolved efficiently.Work Location

2 days a week in our brand new office in Porto or Cambridge with some travelWhy 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, with a healthy work-life balance while making meaningful contributions.Career Growth:

A clear path for progression with opportunities to take on more responsibilities as you develop your skills.Our Core Values

We do Stellar Science:

Create novel therapies with high quality and innovative science.We go beyond:

Be positively disruptive and bold in challenging norms.We unlock value:

Create long-term value for investors and communities.Seniority level

Mid-Senior levelEmployment type

Full-timeJob function

Quality ..... full job details .....