Manager Quality (GCP) - Fixed Term Contract

Moonlaketx; Portugal; Híbrido; EUR 60 000 - 90 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Learning Environment

Impactful Work

Flexibility and Balance

Career Growth

Resumo da oferta

MoonLake seeks a Manager Quality (GCP) to ensure robust GCP compliance across clinical development programmes. You will lead audits, manage quality risks, and support inspections readiness while providing operational quality support to clinical teams and vendors.

Responsibilities include governance of quality issues, CAPA, and collaboration with CRO leads. This role requires strong GCP knowledge and excellent communication in a hybrid Porto-based environment.

Qualificações

• Bachelor's degree in life science or healthcare preferred.
• Experience managing quality issues and CAPAs in biotechnology/biopharma.
• Proven track record monitoring GCP compliance in biotech/biopharma.
• Experience conducting GCP clinical audits as lead or support auditor.
• Experience with quality oversight of clinical trials from protocol development to reporting.

Responsabilidades

• Provide GCP Quality Oversight and clinical trial support across MoonLake and vendors.
• Offer quality guidance to assigned clinical trial teams as sponsor Study GCP Quality Lead.
• Attend internal clinical meetings and provide Quality representation on trials.
• Collaborate within GCP team to oversee all GCP activities in MoonLake and subcontractors.
• Oversee quality risk management processes to ensure inspection readiness.
• Lead CAPA and CAPA-effectiveness checks for assigned programmes.
• Conduct internal and external GCP/GCLP audits; support vendor qualifications and QA assessments.
• Support GCP inspection readiness activities and regulatory inspections.
• Maintain and monitor the QMS to meet regulatory requirements for GCP compliance.
• Track quality metrics and dashboards for senior management and study teams.
• Report progress and issues to the Director, GCP.

Conhecimentos

GCP knowledge

Audit processes

CAPA management

Quality risk management

Regulatory compliance

Clinical trial oversight

Stakeholder communication

CRO collaboration

Quality documentation

GxP systems

Formação académica

Bachelor's degree in life science or healthcare

Descrição da oferta de emprego

Manager Quality (GCP)

The Manager Quality (GCP) ensures robust GCP compliance and quality oversight across MoonLake´s clinical development programmes by serving as a quality expert, leading and supporting audits, managing quality risks, and supporting inspections readiness. The role provides operational quality support to clinical teams and vendors to ensure trials are conducted to the highest regulatory standards.

Key Accountabilities

• GCP Quality Oversight & Clinical Trial Support: Support implementation and delivery of GCP Quality oversight requirements within MoonLake and our vendors.
• Provide quality guidance to assigned clinical trial teams (acting as sponsor Study GCP Quality Lead).
• Attend internal clinical meetings and provide Quality representation on assigned clinical trials.
• Collaborate and share information within GCP team to ensure ongoing oversight of all GCP activities within and subcontracted by MoonLake.
• Ensure proactive oversight of quality risk management processes in assigned clinical programme/trials, including quality risk assessments and management to ensure clinical programmes are always complying and inspection ready.
• Quality Issues, CAPA & Risk Management: Act as Study GCP Quality lead for Quality issues, CAPAs, and CAPA effectiveness checks for assigned clinical programmes/trials and working with Owners and counterpart CRO leads to resolution.
• Audits, Inspections & Vendor Oversight: Conduct (as Lead or Support auditor depending on areas of expertise) assigned internal and external (vendor) GCP and/or GCLP audits. Conduct vendor qualifications and QA assessments. Support GCP inspection readiness activities and management of regulatory inspections of MoonLake (e.g. mock inspection activities and backroom activities, etc.).
• Quality Systems & Documentation: As a member of the MoonLake Quality Team, maintain and monitor the GxP Quality Management System (QMS). Ensuring that the QMS meets all necessary regulatory requirements, including good practice guidelines and standards, with specific emphasis on GCP compliance. To maintain awareness of, and ensure compliance with, policies and procedures relating to quality standards within the Company.
• Performance Monitoring & Quality Metrics: Maintain agreed quality metrics and dashboards to enable clear communication to senior management and clinical study teams of compliance performance and any risks or issues identified. To provide support and advice to clinical study teams with regards to management of quality issues, CAPAs and changes.
• Reporting & Governance: Ensure that Director, GCP is kept informed of progress, highlighting successes as well as potential issues on clinical programmes or Moonlake Quality management system activities.

Education

Bachelor´s degree in life science or healthcare field is preferred.

Experience

• Experience of managing quality issues and CAPAs in a biotechnology or biopharma setting.
• Proven track record in monitoring GCP compliance within biotechnology or biopharma companies.
• Conducting GCP clinical audits as lead or support auditor (investigator site audits, GCP vendor audits, process/system audits during end-to-end clinical lifecycle).
• Experience of quality oversight of clinical trials, from protocol development to clinical study reporting is preferred.

Skills / knowledge / behavioural competencies

• Demonstrable knowledge of GCP and related industry/regulatory guidelines.
• Working knowledge of audit processes and audit conduct.
• Confident communicator, both verbally and written.
• Critical thinking, risk management and risk-based mindset.
• 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.
• The ability to interrogate and analyse systems to identify new ways of working.

Work Location

2 days a week in our brand new Porto office.

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 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 pos