Head of Clinical Compliance

Key responsibilities:

• Act as a strategic driver to evaluate, optimize and implement the pro-active, fit-for-purpose and risk-based Clinical Quality Strategy ensuring compliance during the day-to-day clinical drug development activities
• Drive the quality culture and create quality awareness throughout the clinical development organization
• Drive effective planning/project management of Clinical Development Quality activities across DPI portfolio
• Lead/manage a team of Clinical Development Quality Leads ensuring proper risk-based quality support at a project level
• Allocate dedicated compliance resources to adequately support the respective Clinical Development activities
• Establish & monitor operational quality objectives of Clinical Development Quality Leads (applying cascading mechanism supporting the departmental Quality and DLT Objectives) and ensure timely Quality Plan development and execution in line with business/project timelines
• Coach and lead Quality representatives and Business stakeholders by providing leadership, expert advice, support and management for translating the Quality strategy into operations
• Contribute to preferred CRO/Vendor selection and qualification process, assess relevant CROs procedures during selection process
• Provide clinical development quality oversight and contribute / participate during CRO/Vendor Governance meetings
• Build collaborative working relationships with business stakeholders (including senior leaders) and ensure adequate communication within the compound-specific teams and cross-functional Quality peers
• Drive and ensure continuous alignment on the clinical development quality ways of working across the different projects/clinical trials through engaging with key stakeholders and functional teams
• Oversee and/or contribute to compound-specific Regulatory Authority Inspections / Due Diligence Activities
• Ensure adequate Audit / CAPA support of Clinical Development Quality Leads, by assisting the DPI business stakeholders to ensure proper CAPA formulation and follow-up
• Might act as Clinical Development Quality Lead of a specific project or as back-up if required

Your profile:

• At least 15 years’ experience in an agile, mid-size biopharmaceutical company, with at least 10 years in Clinical Quality
• Master’s degree in Science
• Ability to be a strategical thinker and be a driver to bring efficiencies and simplifications in daily activities
• Having demonstrated the ability to drive significant changes in a Clinical Quality Management organization
• Experience in strategic partnering with senior leaders and quality representatives
• A comprehensive working knowledge of data integrity and risk management (risk assessment and risk mitigation)
• Capacity to think strategically and to keep an overall view while bringing efficiency to daily detailed activities. Ability to make timely and appropriate decisions as related to the GCP expert and client area
• Capability to quickly analyze problems, communication options and take appropriate action for resolution
• Demonstrates consistent judgement under usual business conditions. Involves others in decision-making processes as appropriate
• Effective cross-functional and cross-cultural skills
• Global business thinking within GCP expert & client area
• A good and thorough understanding of current regulatory requirements.
• Ability to interpret current regulations and requirements is essential
• Excellent verbal and written communication and interpersonal skills
• Excellent presentation skills and ability to present content in front of senior management
• Rigor, flexibility, adaptability, and organization
• Pragmatism focused on efficiency and continuous improvement
• Technical skills in view of system / application / software related activities