Job Description

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

We are seeking an experienced and dedicated Clinical Development Quality Lead (CDQL) to provide expert quality oversight across our clinical development portfolio. This critical contractor role is responsible for the proactive identification and mitigation of risks to maintain the highest standards of GCP compliance, protect patient safety, and ensure the integrity of our clinical trial data. If you thrive on providing strategic guidance, meticulous oversight, and driving continuous improvement, this is your opportunity.

Your Mission.

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.

2. 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.

3. 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).

4. 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.

Requirements

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.