T2513 - Clinical Development Quality Lead - Contractor 12 months

We are currently looking for a motivated and collaborative Clinical Development Quality professional to join our Quality Department based at our Headquarters in Lausanne, Switzerland as

Clinical Development Quality Lead - Contractor 12 months

If you thrive on providing strategic guidance, meticulous oversight, and driving continuous improvement, this is your opportunity.

1. GCP Support and Continuous Oversight

• Provide expert GCP guidance and support to all clinical development stakeholders.
• Maintain and manage the GCP query log, ensuring timely logging, tracking, and resolution of all GCP-related questions.
• Conduct study document training compliance follow-up for the Clinical Trial Team (CTT) to ensure protocol and study-specific updates are current.

1. Quality Risk Management & Trending

• Review and assess study risks in collaboration with stakeholders, facilitating the identification of study-specific critical data and processes.
• Develop, generate, and monitor Key Risk Indicators (KRIs) on a monthly/quarterly basis through advanced analytics.
• Perform comprehensive trending analyses on KRIs, protocol deviations, and quality events to identify patterns and communicate potential quality issues, supporting mitigation planning.

1. Vendor Qualification and Quality Event Management

• Lead the qualification assessment of clinical vendors to ensure compliance with regulatory requirements and internal processes.
• Ensure effective quality oversight and continuous monitoring by working closely with stakeholders and vendor QA representatives.
• Support stakeholders in managing Quality Events, including detailed investigations and Root Cause Analyses (RCA).
• Assist in the development and implementation of Corrective and Preventive Actions (CAPAs).

1. Audit & Inspection Readiness

• Provide input to audit management for risk assessments to support the annual audit plan.
• Assist stakeholders in meticulous preparation for audits (site, vendor, TMF) and regulatory inspections.
• Review CAPAs related to audits and inspections to ensure thoroughness and compliance alignment.

More than a checklist of skills, we’re looking for someone who shares our commitment to science with purpose.

• University Degree in Sciences or a relevant academic background
• 6-8 years’ experience in the clinical setting of the pharmaceutical/biotech industry, including at least 3 years in a similar role.
• Proven experience in managing and conducting GCP audits (CROs, TMF, Investigational Sites, and CSR).
• Excellent knowledge and current, strong working knowledge of GCP, CFR Title 21, and regulatory guidances, including ICH Quality, Clinical, Multidisciplinary Guidance documents, and 21 CFR Part 11 compliance.
• Strong experience in the mechanism of multiple QA vendor oversight.
• Must demonstrate pragmatism focused on efficiency and continuous improvement attitude
• Capacity to think strategically and maintain an overall view while bringing efficiency to daily detailed activities.
• Excellent communication in English, with strong interpersonal skills

What to Expect in the Recruitment Process:

If your application is selected, you’ll 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 Workable—check your spam folder for emails from *@outbound.workable.com.

Benefits

What we Offer:

• 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

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