Clinical Development Quality Lead

Key responsibilities:

• Develop a “risk-based” compound-specific compliance program contributing to document / data accuracy, ultimately resulting in “dossier acceptability” by respective out-licensing partners (emphasis on eCTD Module 5)
• Contribute to CRO/Vendor selection and qualification process, assess relevant CROs procedures during selection process to establish a pro-active quality approach, guaranteeing compliance with regulatory requirements
• Collaborate with the Clinical Trial Manager and other Functional Area Representatives in the Study Team to ensure proper DPI set-up & oversight of outsourced CRO activities, with primary focus on critical data points (primary endpoints) and critical processes
• Provide compliance support and contribute to “in process / ongoing” oversight through evaluation & follow-up on reported quality events potentially jeopardizing the validity of the clinical study
• Collaborate cross-functionally to the development and review of critical clinical study documents to ensure cross-document consistency e.g. IB versus Clinical Trial Protocol versus Master Informed Consent Form, …
• Applying the risk-based approach, identify the need to & conduct co-auditing activities / quality visits with DPI and / or CRO representatives
• Provide continuous compliance support by acting as an internal advisor on relevant procedures and regulations to ensure correct interpretation and proper implementation
• Create KQI to identify areas for improvement based on risk-based compliance activities and audit observations
• Lead / contribute to compound-specific Regulatory Authority Inspections / Due Diligence Activities
• Build collaborative working relationships and ensure adequate communication within the compound-specific study team and cross-functional Quality peers, assist in driving change to build a culture of compliance throughout the Clinical Development organization
• Provide Audit / CAPA support to the execution of Master Audit Plan executed, assist the DPI business stakeholders to ensure proper CAPA formulation and follow-up
• Provide support to the development / maintenance of QM andclinical developmentrelated procedural documents

Your profile:

• University Degree in Sciences or relevant academic background
• 6-8 years’ experience in the clinical setting of the pharmaceutical/biotech industry, including at least 3 years within Clinical Quality Management System & Compliance
• Experience in managing and conducting GCP audits (CROs, TMF, Investigational Sites and CSR)
• Excellence knowledge of GCP. Current and strong working knowledge of GCP, CFR Title 21 and regulatory guidance’s including, ICH quality, clinical, multidisciplinary guidance documents, and 21 CFR Part 11 compliance
• Strong experience in the mechanism of multiple QA vendor’s oversight
• Experience in setting and updating SOPs
• Knowledge of computerized systems validation
• Rigor, flexibility, adaptability and organization
• Pragmatism focused on efficiency and continuous improvement
• Capacity to think strategically and to keep an overall view while bringing efficiency to daily detailed activities
• Fluent in English, French an asset