P2516 - Clinical Development Quality Team Lead

At Debiopharm every step we take is guided by one purpose: improving the lives of people affected by cancer and infectious diseases. As a privately-owned Swiss biopharmaceutical company were driven by science but above all by the people behind every treatment the patients and their families.

Through our unique development only model we bring forward promising therapies and transform them into treatments that can reach those who need them most faster.

To strengthen our Quality Management organization in Lausanne we are looking for a

Clinical Development Quality Team Lead ( 100%)

As a hands-on Clinical Development Quality Team Lead you will lead the Clinical Development Quality Team driving compliance to the DPIs Quality Management System (QMS) ensuring consistent adherence to regulatory requirements and guaranteeing the company is always Good Clinical Practice (GCP) - inspection ready. You will also actively contribute to the operational implementation of our Clinical Quality strategy. This role is ideal for someone who is as comfortable with supporting and partnering with cross-functional project teams as with working with Line Functions Leadership to build a foundational risk-based pragmatic quality framework.

Your Mission

• Evaluate optimize and implement a proactive risk-based Clinical Quality Strategy that ensures compliance throughout our day-to-day clinical development efforts.
• Monitor the external GCP environment including trends and lead the interpretation of the impact to the organization of regulatory changes.
• Lead the evaluation of necessary changes in internal processes to ensure compliance with the evolving regulatory landscape.
• Champion a pragmatic quality culture within the Clinical Development Quality Team and throughout the organization.
• Manage a team of Clinical Development Quality Leads (CDQLs) ensuring they provide robust risk-based and pragmatic quality support at the project level aligned with the business objectives.
• Lead the effective planning and project management of Clinical Development Quality activities across our portfolio. This includes strategically allocation of CDQL resources to adequately support our clinical development activities ensuring effective and efficient operations.
• Coach Quality representatives and business stakeholders providing expert advice and management to seamlessly translate our Quality strategy into pragmatic actionable operations.
• Ensure appropriate contribution of the Clinical Development Team for the selection and qualification process for CROs and vendors
• Ensure Clinical Development Quality oversight and actively participate in CRO/Vendor Governance meetings
• Foster collaborative working relationships with key business stakeholders including senior leaders to ensure alignment and shared success.
• Drive continuous alignment on clinical development Quality ways of working across different projects and clinical trials by coaching CDQLs and engaging with key stakeholders and functional teams.
• Oversee Regulatory Authority Inspections and GCP audits performed by licensees of DPI compounds; contribute to compound-specific Due Diligence Activities.
• Ensure adequate audit and CAPA support assisting business stakeholders in formulating and following up on corrective and preventive actions.
• Act as a CDQL for selected projects

More than a checklist of skills were looking for someone who shares our commitment to science with purpose.

• Masters degree in a scientific field or equivalent
• 15 years of experience in the biopharma industry ideally in small to mid-sized fast-moving biotech settings with at least 10 years in Clinical Quality with a track record of implementing quality systems and processes in operational settings
• Comfortable in both strategic planning and operational execution you thrive on turning vision into reality
• Capability to quickly analyze problems propose options and take appropriate action for resolution
• Strong knowledge of GCP data integrity and risk-based quality management principles
• Experience working closely with CROs and contributing to their selection and oversight
• Hands-on collaborative leadership style with the ability to coach influence and partner across teams and organizational levels
• Demonstrated ability to balance compliance with business pragmatism focused on efficiency and delivering fit-for-purpose solutions
• Excellent problem-solving skills and decision-making ability especially in dynamic changing environments
• Rigor flexibility adaptability with strong ability to prioritize
• Excellent verbal and written communication and interpersonal skills in English able to engage scientific stakeholders auditors and executives alike

• Being part of a company where innovation collaboration and impact arent just values theyre 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

What to Expect in the Recruitment Process:

If your application is selected youll be invited to interviews with Talent Acquisition and the Hiring Manager via Teams followed by a panel interview and reference checks. Communication is handled via Workablecheck your spam folder for emails from *@.

Please contact our HR Department prior to submitting any profiles. We cannot accept unsolicited applications from agencies or recruiters