Associate Director, Good Clinical Practice, GCP Audits and Inspections

🕒 February 18

🌐 Switzerland, France, +2 more countries – Remote

🇨🇭 Switzerland – Remote 🇫🇷 France – Remote 🇬🇧 United Kingdom – Remote 🇳🇱 Netherlands – Remote

💵 CHF148.9k - CHF186.1k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 46%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Lead and conduct risk-based GCP audits, including investigator site, vendor, process/system, internal, and for-cause audits • Plan, prepare, conduct, document, and report audits • Evaluate audit findings, corrective and preventive actions (CAPAs), and follow up through closure • Develop and execute GCP audit strategies and plans • Identify audit trends, systemic compliance risks, and quality improvement opportunities • Lead or co-lead GCP inspection readiness activities and support Health Authority inspections • Develop and execute risk-based inspection readiness strategies with clinical study teams and subject matter experts • Support inspection preparation, including risk assessments, storyboards, mock inspections, and readiness assessments • Coordinate inspection requests and support subject matter experts during inspections • Support post-inspection activities and CAPA follow-up • Provide GCP quality leadership and guidance for assigned compounds or clinical development programs • Identify, assess, communicate, and mitigate GCP compliance and quality risks • Provide independent quality perspectives and strategic GCP advice • Provide GCP quality oversight of CROs and other GCP service providers • Support vendor qualification and risk-based quality oversight • Lead or conduct vendor audits and quality assessments • Review vendor quality performance, compliance issues, deviations, and emerging trends • Provide GCP quality input into vendor governance and continuous improvement • Serve as a GCP subject matter expert for internal stakeholders • Build partnerships across Clinical Operations, Regulatory Affairs, Quality, and other functions • Improve GCP audit and inspection processes, tools, and quality systems • Maintain awareness of evolving global GCP regulations and industry practices • Mentor auditors and other Quality personnel • Utilize Veeva Vault and other quality systems for planning, documentation, tracking, and oversight

🎯 Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Business, or related field • Minimum 8 years of relevant experience in GCP Quality Assurance, GCP auditing, regulatory inspection support/management, Clinical Operations, or related pharmaceutical/biotechnology clinical research activities • Demonstrated experience conducting and leading GCP audits, including investigator site, vendor, process/system, and/or internal audits • Experience supporting or leading GCP regulatory inspection readiness and Health Authority inspection activities • Strong knowledge of ICH GCP, applicable global clinical trial regulations, and regulatory expectations • Demonstrated ability to identify, assess, communicate, and support mitigation of complex GCP compliance and quality risks • Excellent leadership, communication, analytical, and problem-solving skills • Ability to manage multiple projects and stakeholders in a fast-paced environment • Proficiency in relevant vendor management systems • PC literacy required: MS Office skills (Outlook, Word, Excel, PowerPoint) • Certification in GCP auditing or clinical research is a plus • Experience working with electronic Trial Master File (eTMF) and Clinical Trial Management Systems (CTMS) • Familiarity with risk-based quality management (RBQM) principles • Advanced experience in Veeva Vault Quality Suite implementation and management • Leadership experience and mentoring skills may be required for supervisory responsibilities • Flexible to travel, including international; may require up to 35% travel • Audit travel mostly overnight for on-site audits is required, anticipating a minimum of 2 audits per month

🏖️ Benefits

• Flexible to travel, including international • Equal opportunity employment