Director, GCP/GVP Quality & Compliance
Location: Basel areaLength: 12-MonthWorkload: 100%Start Date: ASAP
We are supporting a leading biotech organization and are looking for an experienced Director, GCP/GVP Quality & Compliance to strengthen the R&D Quality function. This is a hands‑on role focused on developing, implementing, and overseeing the GCP and GVP quality framework while ensuring inspection readiness and strong compliance across clinical development activities. The position plays a key role in driving quality oversight, managing risk‑based audit programs, and supporting cross‑functional teams and external vendors in maintaining high regulatory standards. You will work closely with clinical development teams, quality leadership, and external partners to ensure compliant processes, effective risk management, and a strong quality culture across the organization.
Responsibilities
Provide quality oversight for clinical development activities to ensure compliance with GCP and GVP requirements
Act as the GCP Quality interface and provide expert guidance to internal stakeholders and project teams
Ensure inspection readiness by identifying compliance gaps and ensuring CAPA actions are implemented effectively
Collaborate with internal teams and external partners to implement global regulatory and industry compliance standards
Manage and execute risk-based GCP/GVP audit programs
Strengthen QA oversight of key CRO vendors, including development and monitoring of quality KPIs
Plan, conduct, and report internal and external audits including vendors and clinical sites
Identify and assess compliance risks and implement appropriate mitigation strategies
Ensure timely follow‑up and resolution of identified quality issues
Develop, review, and implement Clinical QA SOPs and quality processes
Support and lead continuous improvement initiatives within the Quality organization
Support preparation and review of regulatory submissions to global health authorities
Lead or support health authority inspections and related readiness activities
Provide QA oversight of clinical systems such as eTMF, CTMS, and vendor quality systems to ensure compliance
Deliver training on regulatory requirements and quality compliance topics
Contribute to quality strategy, departmental objectives, and broader organizational goals while promoting a strong quality culture
Requirements
Bachelor’s or Master’s degree in a scientific discipline
10+ years of experience within the pharmaceutical or biotech industry in Quality roles
Extensive knowledge of GCP and working knowledge of GVP regulations
Strong familiarity with international regulatory frameworks including FDA, EMA, MHRA and ICH guidelines (including ICH E6)
Experience supporting or leading regulatory inspections
Demonstrated experience managing audits and vendor oversight in clinical development
Strong leadership and stakeholder management skills across cross‑functional teams
Excellent communication, presentation, and training abilities
Highly organized with strong attention to detail and ability to manage multiple priorities in a fast‑paced environment
Ability to work independently while collaborating effectively across global teams
Willingness to travel internationally when required
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