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ProfileSenior Manager, R&D Quality The candidate must have work with GR&D Quality Management in the risk based identification and planning of CSV audits/audit program. Engage appropriate business partners in the planning of CSV audits (system/vendor) using a risk based approach to ensure the highest risks are identified and prioritized. Conduct and report CSV audits aligned to highest risks, engaging partner audit input as appropriate. Develop audit reports which support the business in addressing quality issues and continuous improvement. Work with management in the development and provision of meaningful audit metrics and trending reports. Provide expert CSV related consultation and advice to business partners in GCP, GLP, GMP, and PV regulated environments. Act as the key point of contact for nominated business partners to support identification of most significant CSV compliance risks. Liaise with business partners to discuss implications of relevant findings and/or share regulatory agency trends.
Qualification and Experience
The candidate must have demonstrated knowledge of Computer System Validation in a global GxP environment. General understanding of preclinical, clinical, pharmacovigilance, and manufacturing processes and systems. Experience in CSV auditing in a global GxP environment; In depth understanding of preclinical, clinical, pharmacovigilance, and manufacturing processes and systems Operational experience in a GLP, GCP, PV, GMP, CSV QA, or CSV IT capacity will be considered, Extensive knowledge of global regulatory requirements. Knowledge/understanding of the approach and perspectives of regulatory agencies. Ability to ensure strategic risk focus and prioritize activities in response to the myriad of complex, inconsistent, and constantly evolving global regulations and expectations. Excellent written and verbal communication skills including presentation skills. must have Bachelor’s degree (BA/BS) degree in a Technical Discipline (Life Sciences, Computer Science, Engineering, etc.). Preferred Education: Advanced degree (MS/PhD) in a Technical Discipline (Life Sciences, Computer Science, Engineering, JD, MD, etc.)
ref : 166093