Director, GCP/GVP Quality & Compliance m/f/d, Basel-Stadt The Director, GCP/GVP Quality & Compliance will be responsible for further development, implementation and oversight of the Good Clinical Practices and Good Pharmacovigilance Practices quality system.
This is a hands-on, individual contributor role centered on leading a risk-based audit program, leading QA support for clinical development activities, and providing QA oversight of key vendors.
The position requires an expert knowledge of GCP and a good working knowledge of GVP. This person will act as a subject matter expert within the department and for partner functions , as well as providing compliance oversight to external vendors. This person must be capable of formally and informally influencing, leading, and guiding both internal functions and external vendors through collaborative relationship building.
Contract duration: 12 months
Location: Basel
Travel: up to 20%
Responsibilities - Provide oversight on day-to-day activities in GCP/GVP which includes clinical trial team support for selected studies to ensure compliance standards are achieved.
- Manage the GCP Quality interface and provide expert consultancy to key stakeholders.
- Ensure GCP inspection concerns are identified and any CAPA actions completed to close gaps
- Collaborate with internal and external stakeholders and partners to enable and ensure appropriate implementation of applicable global compliance requirements and associated industry guidelines as applicable to GCP/GVP.
- Manage and implement assigned GCP/GVP risk-based audit programs.
- Strengthen QA oversight of key CRO vendors, including development and monitoring of GCP quality KPIs Plan, prepare, conduct and report internal and external GCP/GVP audits as assigned, including vendors and clinical sites.
- Identify, document and assess compliance risk areas and implement risk mitigation measures, maintain the RQA Risk-Register.
- Ensure timely and effective follow up of all identified quality issues.
- Develop, review and implement Clinical QA SOPs and processes.
- Support process improvement initiatives; Lead continuous process improvements within Quality as assigned.
- Lead in the preparation and review of regulatory submissions for FDA and global health authorities, as required.
- Lead or support managing Health Authority inspections as required.
- Maintain high level of awareness and expertise in international GCP (including GVP)regulations and provide input into the development of quality standards and procedures in related system and processes.
- Develop and conduct training on current regulations and compliance issues.
- Contribute to R&D Quality strategy, departmental objectives, and company goals .
- Continue to drive Quality Culture. Provide routine quality updates and risk reporting to QA leadership.
- Provide QA oversight of clinical systems (eTMF, CTMS, vendor quality systems) to ensure inspection readiness and compliance.
- Other duties as assigned.
Requirements - BS/MS or equivalent in a scientific discipline and 10+ years of relevant experience within the pharmaceutical industry including a leadership role in Quality.
- Extensive knowledge of pharmaceutical/biotech industry centered on ICH Regions such as FDA, EU and Japan, including ICH E6 R2/R3, and MHRA, EMA and FDA inspection experience
- Strong leadership with demonstrated ability to interface with senior leaders and different levels of the organization.
- Excellent organizational, interpersonal, and communication skills, both verbal and written, with the ability to facilitate meetings, conduct training and to present information in an advisory capacity.
- Attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment.
- Able to travel (some international) up to 20%.
- Ability to work both independently and collaboratively with project teams and cross functionally, to build productive relationships with internal and external partners, to influence decision making and to engage in conflict resolution.
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