SRG are currently looking for RDQA Area Associate for a Global Pharmaceutical Company who have opened a new vacancy within their Clinical team on an initial 12 Month basis to be based at their office in Maidenhead.The Role:The RDQA Associate is responsible for supporting the RDQA AREA Head and AREA managers across global regions with the implementation/execution of activities related to proactive quality management within Affiliates.
Key Responsibilities:* Maintain a close, collaborative relationship with RDQA functions impacting clinical research activities including clinical trials within designated Affiliates in the assigned AREA. * Establish collaborative-working relationships in order to advance the Quality System, drive quality excellence, and achieve first pass approval for market authorization by health authorities. * Oversight of quality and compliance in a regulated environment. * Support AREA managers with operational aspects linked to the following:o development of risk identification and risk mitigation or control strategies for clinical research activities.o ensuring consistent understanding of the quality requirements for clinical research activities within Affiliates, works closely with Affiliates R&D Management on health of Quality System, identifies issues of quality and compliance that will impact overall goals and desired outcomes.o Inspection support in collaboration with AREA Head and relevant functions and provide inspection-readiness support for all local Health Authority inspections. Provides governance, oversight, support and follow-up for local Health Authority inspections.o supporting the development of robust audit and inspection responses through coaching and education.* The incumbent must be agile and able to respond rapidly to unplanned events, changing needs of development programs as well as changing regulatory requirements and expectations. * Must apply critical thinking and be able to formulate decisions and approaches in the complex, matrix world of the clinical research & development with all associated business partners.* Strong understanding of ICH GCP.Skills/Experience Required:* Bachelor's degree required preferably in Biology, Nursing, Pharmacy, or other medical science degree combined with equivalent technical experience. * Well-developed collaboration attributes including ability to influence colleagues to bring about alignment and motivate towards a shared purpose. * Strong analytical skills and the ability to organize work. Ability to work at an experienced level, demonstrating effective leadership in interactions with business partners at all levels.* Excellent communication (written and oral) skills. * Ability to work in a fast-paced, high pressure and changing environment in an autonomous manner.* Project management, interpersonal, and communication skills. Strong team player or team lead and builds relationships. * Extensive knowledge of the clinical development for biopharmaceuticals.* Biopharmaceutical industry experience in quality assurance, compliance, regulatory affairs, clinical research and/or other related development functions * Ability to travel as neededIf you are interested in this role or would like to have a confidential career discussion regarding other Clinical Regulatory Opportunities. Please contact me: email@example.com or +441615077288
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