Join to apply for the Senior Manager Quality GCP Compliance role at MoonLake Immunotherapeutics (NASDAQ: MLTX)
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Join to apply for the Senior Manager Quality GCP Compliance role at MoonLake Immunotherapeutics (NASDAQ: MLTX)
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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.
Key accountabilities:
* As part of the MoonLake Quality GCP Team, in consultation with the Director, GCP Quality, Key stakeholders, and using available resources:
* 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 pro-grammes 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
* To 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 working in Clinical Quality Assurance and/or Clinical Operations (e.g., Clinical Trial Management, Clinical Monitoring) will be considered. Substantial knowledge of Good Clinical Practice (GCP) requirements 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 and knowledge of GCP requirements in USA, EU, UK and experience with providing clinical GCP/Quality Assurance expertise on 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 ensure the detection of 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 skills.
* Highly developed negotiation and influencing skills.
* Highly developed conflict resolution abilities.
* Demonstrates an in-depth knowledge of GCP and GCLP and related industry/regulatory guidelines governing clinical trials in the EU & USA as applied to late-stage product development and licensure.
* Some knowledge of other GxPs, including GMP, as applied to clinical development would be an advantage
* Critical thinking, risk management and risk-based mindset.
* Ability to clearly communicate with members of staff at all levels through-out the organization, up to and including executive level.
* 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.
* Highly developed decision-making skills, including dealing with ambiguity when reaching decisions.
* 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.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
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