P2622 - Audit & CAPA Lead — Debiopharm
NouveauCHF 174 500 - 306 000
Debiopharm · Lausanne (VD)
- Lieu
- Lausanne
- Contrat
- other
- Publié
- il y a 5 jours
SalaireCHF 174 500 - 306 000
Vue d’ensemble du poste
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.
Responsabilités principales
- 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.
Exigences principales
- 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.
Ce que l’entreprise offre
- 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
Entreprise et contexte
- 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.
Détails supplémentaires
- 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 et contenu original
- 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
