P2622 Audit & CAPA Lead

Description

TheRole: Mission

As the Audit & CAPA Lead you will ensure an effective pragmatic and risk-based Audit & CAPA framework atDebiopharm. Your focus will be on strengthening quality oversight supporting inspection readiness and driving continuous improvement for all our clinical trials programs across allGxPactivities and GCP/GcLP in particular.

Key Responsibilities

In this role you willbe responsible to definearisk-based audit strategy in close collaboration with keystakeholders andwillact as the global Audit & CAPA process and system owner serving as the single point of contact to support business representatives. Your core duties will include:

• Strategic Audit Management:Define the risk-based audit strategy alongsideGxPQuality Leads and Business Partners. Createmaintain and execute the Master Audit Plan (covering third parties systems studies and documents).
• Perform Internal Audit : on clinical trials programs or Debiopharm internal processes (mainly in GCP area).
• Vendor & Auditor Oversight:Selecting and managing qualified outsourced auditors (when appropriate) to ensuretimelyexecution and compliance with regulatory standards.
• Risk-Based Quality Assurance:Embed ICH Q9 concepts and quality risk management practices across the entire audit and CAPA lifecycle. Use trend analysis and key quality indicators to escalate critical issues and focus assurance where it matters most.
• Inspection Readiness & CAPA:Lead the preparation and conduct of Regulatory Authority Inspections. Partner withGxPQuality Leads to developtimely impactful CAPAs.
• Metrics & Continuous Improvement:Develop and generate meaningful Audit/CAPA metrics to provide clear oversight for department heads and drive global continuous improvement initiatives.
• Hands-on Auditing:Conduct targeted audits on behalf ofDebiopharmInternational S.A.

Requirements

Your Profile

Education & Experience:

• University Degree:Pharmacist Diploma PhD MSc or BSc in Science (or equivalent experience).
• Industry Experience:At least 5 to 8 years managing quality assurance within the pharmaceutical and/or biotech industry. Hybrid experience in both large and small/medium sizestructures would be a real asset.
• Audit Expertise:Minimum 5 years of experience conducting audits and supervising audits in GCP environments (mandatory) and GLP / other GxP audits is a plus.
• GCP Inspection Experience: Recent and strong experience in leading preparation of Regulatory Authorities GCP inspections (eg. FDA EMA MHRA)
• Systems Experience:Minimum 3 years tracking CAPAs deviations and changes (e.g. for GCP: CROs TMF Investigational Sites and CSR). Direct experience with validated electronic quality tools (e.g. Veeva Ennov) and knowledge of computerized systems validation is highly desirable.

Skills & Core Competencies:

• Solid comprehensive knowledge ofGxPand practical familiarity with risk-based approaches like ICH Q9.
• Proven experience implementing risk-based approaches in alignment withcurrentICH E6(R3)andICH E8(R1)regulatory frameworks.
• Proven ability tomaintainquality SOPs and translate business priorities/risk signals into a pragmatic inspection-ready program.
• A strategic thinker who canmaintainan overarching global view while bringing rigor and efficiency to daily detailed communicator being strongly exposed to matrix organizations and cross-functional collaborations.
• High degrees of organization flexibility and ahands-onpragmatic mindset focused on continuous improvement.

Benefits

WhatweOffer:

• Being part of a company where innovation collaboration and impactarentjust values theyrehow we work every day
• Partner with teams across disciplines at the forefront of oncology and anti-infective development
• An inclusive and respectful workplace proud to be Equal-Pay certified
• Grow in a culture that values people purpose and performance
• A chance to grow share and shape the future of healthcare

What to Expect in the Recruitment Process:

If your application is selectedyoullbe invited to interviews with Talent Acquisition and the Hiring Manager via Teams followed by apanelinterview and reference checks. Communication is handled via Workablecheck your spam folder for emails from*@.

Please contact our HR Department prior tosubmittingany profiles. We cannot accept unsolicited applications from agencies or recruiters.

Employment Type : Full Time
Experience: years
Vacancy: 1