Vice President, Quality and Regulatory Compliance

ppDescription /p h3JOB SUMMARY /h3 pThe Vice President of Quality Assurance is responsible to implement and support strategies for Quality System processes and supporting technology, and ensuring the integrity, consistency, and harmonization of these processes and systems for Clinilabs. /p pThis individual is also accountable for ensuring that the clinical activities are in compliance with current Good Clinical Practices (cGCP) and governmental regulations through creation and maintenance of quality and compliance systems within Clinilabs that monitor quality, efficiency, and uniformity of clinical trials and associated activities, both internally externally. /p pThis Vice President will provide regulatory expertise regarding all regulatory submissions for site services, clinical research organizations, client companies and internal project teams on regulatory requirements for all Clinilabs’ activities. /p pThis Vice President will develop staff to meet expanding needs of the business and to prepare capable individuals for areas of higher responsibility. This individual must have ability to lead and mentor a team of staff to ensure all key activities and objectives are met. /p h3RESPONSIBILITIES /h3 ulliProvide leadership and direction to a growing quality and regulatory department /liliManage and provide leadership and organizational capability development for quality system, to ensure succession planning and performance standards remain at an optimal level /liliMake decisions on process and system strategy recommendations, defining compliance-driven standards, determining boundaries for harmonization and alignment versus differentiation /liliProvide leadership in setting strategy, implementing, and maintaining Clinilabs Quality Systems /liliAct as quality systems subject matter expert and resource leader for focus areas by partnering with process owners to drive results by identification, selection, and/or facilitation skills /liliProvide leadership and guidance for computer system and software validation, with particular focus on GCP / regulated systems /liliConduct internal and external audits in compliance with company SOPs /liliProvide feedback to the quality control (QC) group /liliEstablish processes, standards, and procedures (as required); and ensure they remain current with regulatory requirements. /liliInteract with FDA and other regulatory bodies /liliProvide qualification audits of contractors and vendors, as needed /liliProvide leadership and guidance on quality agreements /liliDevelop measures to monitor the effectiveness of the deployed quality system /liliIdentify potential quality issues and/or areas for improvement /liliMonitor employee training and training program /liliOversight of controlled document management system /liliConduct / oversee Internal and external audits /liliDevelop and/or monitor vendor qualification program /liliOther duties as assigned /li /ul h3Requirements /h3 ulliThe position requires at least a Bachelor’s degree, although advanced degrees are preferred. /liliA minimum of 15 years working within GXP function is required. /liliA minimum of 10 years of experience in a leadership role in quality and/or compliance is required. /liliProven experience in leading regulatory (FDA, MHRA, Etc.) inspection readiness, inspection activities, and responses /liliStrong influencing, negotiations and leading without direct line authority experience is required. /liliThe ability to manage complexity and manage a diverse team is critical. /liliExcellent written and oral communication and interpersonal relationship skills are required. /liliExcellent leadership, influencing, and collaboration skills are expected. /liliThe selected candidate must come from a regulated industry. /liliAbility to work and communicate in a cross-cultural environment is highly required. /liliPrevious experience driving performance results is required /li /ul /p #J-18808-Ljbffr