P2622 - Audit & CAPA Lead — Debiopharm
- Location
- Lausanne
- Contract
- other
- Posted
- 27 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 across all GxP activities.
- 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, or MSc in Science (or equivalent experience).
- Industry Experience: 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: 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 GxP audits, with a strong preference for GCP & GLP environments.
- 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.
- Recent inspection experience with official Regulatory Authorities (FDA, EMA, Swissmedics) a strong asset.
- 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, or MSc in Science (or equivalent experience).
- Industry Experience: 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 GxP audits, with a strong preference for GCP & GLP environments.
- 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.
- Recent inspection experience with official Regulatory Authorities (FDA, EMA, Swissmedics) a strong asset.
- 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:
- 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
- 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.
