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T2513 Clinical Development Quality Lead Contractor 12 months
T2513 Clinical Development Quality Lead Contractor 12 monthsDebiopharm • Lausanne, Vaud, Switzerland
T2513 Clinical Development Quality Lead Contractor 12 months

T2513 Clinical Development Quality Lead Contractor 12 months

Debiopharm • Lausanne, Vaud, Switzerland
Vor 30+ Tagen
Stellenbeschreibung

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 were 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 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

  • @ .
  • Benefits

    What we Offer :

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

    Required Experience :

    Contract

    Key Skills

    Administrative Skills,Facilities Management,Biotechnology,Creative Production,Design And Estimation,Architecture

    Employment Type : Temp

    Experience : years

    Vacancy : 1

    Jobalert für diese Suche erstellen

    Clinical Development • Lausanne, Vaud, Switzerland

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