P2622 - Audit & CAPA Lead — Debiopharm
- Location
- Lausanne
- Contract
- other
- Posted
- 37 days ago
Role overview
The Role: Mission
As the Audit & CAPA Lead, you will ensure an effective, pragmatic, and risk-based Audit & CAPA framework at Debiopharm.
Your focus will be on strengthening quality oversight, supporting inspection readiness, and driving continuous improvement for all our clinical trials programs across all GxP activities, and GCP/GcLP in particular.
- The Role: Mission
- As the Audit & CAPA Lead, you will ensure an effective, pragmatic, and risk-based Audit & CAPA framework at Debiopharm.
- Key Responsibilities
- In this role, you will be responsible to define a risk-based audit strategy in close collaboration with key stakeholders, and will act 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: Requirements
- 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 size structures would be a real asset.
Main responsibilities
- Key Responsibilities
- In this role, you will be responsible to define a risk-based audit strategy in close collaboration with key stakeholders, and will act 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: Requirements
- 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 size structures 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.
- Solid, comprehensive knowledge of GxP and practical familiarity with risk-based approaches like ICH Q9.
- Proven experience implementing risk-based approaches in alignment with current ICH E6(R3) and ICH E8(R1) regulatory frameworks.
Key requirements
- 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 size structures 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.
- Solid, comprehensive knowledge of GxP and practical familiarity with risk-based approaches like ICH Q9.
- Proven experience implementing risk-based approaches in alignment with current ICH E6(R3) and ICH E8(R1) regulatory frameworks.
- Proven ability to maintain quality SOPs and translate business priorities/risk signals into a pragmatic, inspection-ready program.
- A strategic thinker who can maintain an overarching global view while bringing rigor and efficiency to daily, detailed activities. Agile communicator being strongly exposed to matrix organizations and cross-functional collaborations.
- High degrees of organization, flexibility, and a hands-on, pragmatic mindset focused on continuous improvement.
What the company offers
- Being part of a company where innovation, collaboration, and impact aren’t just values — they’re how 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
Company and context
- Agile communicator being strongly exposed to matrix organizations and cross-functional collaborations.
- High degrees of organization, flexibility, and a hands-on, pragmatic mindset focused on continuous improvement.
Additional details
- In this role, you will be responsible to define a risk-based audit strategy in close collaboration with key stakeholders, and will act 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:
- GCP Inspection Experience: Recent and strong experience in leading preparation of Regulatory Authorities GCP inspections (eg.
- Grow in a culture that values people, purpose, and performance A chance to grow, share, and shape the future of healthcare
Notes and original content
- In this role, you will be responsible to define a risk-based audit strategy in close collaboration with key stakeholders, and will act 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:
- Requirements
- FDA, EMA, MHRA…)
- Grow in a culture that values people, purpose, and performance
- A chance to grow, share, and shape the future of healthcare
Questions about this listing
What salary does Debiopharm offer for this role?
Debiopharm lists CHF 174'500 - 306'000 gross per year for this position in Lausanne. This is the salary published in the original listing (or, when the employer omits a figure, a realistic estimate for the role and sector) — the calculator on this site converts it to your actual net take-home once cross-border tax and social contributions are applied.
Is this a full-time role, and what type of contract does Debiopharm offer?
This listing is a full-time position. The contract type shown here comes directly from the employer's original posting; always confirm exact hours, notice period and probation length with Debiopharm during the application process, since these details can vary by role even within the same contract category.
Do I need a cross-border work permit for a role in Vaud?
EU/EFTA residents living in the border zone of the country adjoining Canton Vaud can apply for a G permit; the Swiss employer files it with that canton's migration office after the contract is signed. Border-zone rules and processing times vary by neighbouring country and canton, so confirm the specifics with Vaud's cantonal migration office or with HR during the application.
How do I apply for this position at Debiopharm?
Use the "Apply now" button on this page — it links directly to Debiopharm's original listing at apply.workable.com, so your application goes straight to the employer's own applicant-tracking system. Frontaliere Ticino does not collect or forward applications itself.
