Provides technical and managerial leadership to one or more scientists supporting site deviations/investigations. Lead and conducts site deviations and ensure that root cause analysis, execution of resulting solutions (CA/ PA) are completed in a timely, effective and compliance manner. Support global investigation program. Participates in multi-disciplinary teams for investigations and technology transfer in support of pharmaceutical processes. Manage the assigned resources toward the fulfilment of investigation function based on a Tier Management process with effective communication. Participate and foster collaboration within the global investigation community within MS&T Manati. Conducts Quality/ Safety Risk management assessments to establish required control systems to minimize risk. Provide technical assistance to supports the establishment of corrective actions to prevent recurrence of Quality Events focused on root cause. Provides training to manufacturing operators, product scientists, and other functions as needed on topics related to the investigation process and procedures. Promotes and model the BMS Core Behaviors, facilitating teamwork. Oversee the certification program for new investigators. Oversees the execution of the investigation processes for Manufacturing Operations at BMS Manati. Assesses Investigation performance and develops improvement plans to advance area maturity in conjunction with site QA, Compliance and Investigations-Global Process Owner. Provides coaching and developmental activities for seniors and juniors scientists investigators. Support BMS Corporate Audits and other regulatory agencies (DEA, FDA, MHRA, ANVISA, etc.) by providing expertise. Knowledge and Skills Required. BS in Engineering, Pharmaceutical or Science with nine (9) years of experience in pharmaceutical operations, specifically in parenteral products or master’s degree in engineering, Pharmaceutical Sciences, Science or Management with six (6) years of experience in pharmaceutical operations, with broad knowledge in specifically in parenteral products. Proficient knowledge of FDA regulatory requirements. Broad knowledge of relevant governmental regulations, cGMPs and guidelines pertaining to a biopharmaceutical manufacturing plant. Ability to write detailed technical reports. Ability to effectively present detailed technical information and respond to technical questions. Knowledge of pharmaceutical business processes. Ability to review SOPs and work instructions. Ability and aptitude to analyze data detecting inconsistencies, determining relative importance and to solve complex technical situations based on data. Excellent technical writing/oral communication skills (English/ Spanish)Excellent Time Management, planning and organization capabilities, Project management skills, leadership and teamwork skills. Able to interact effectively with people to establish and maintain excellent working relationship with at all organizational levels. Able to plan and prioritize multiple complex activities simultaneously. Willing to work irregular hours, rotating shifts, weekends and holidays, when necessary. Ability to make decisions while balancing speed, quality and risk. Experience in identifying and taking informed business risks and escalating issues if needed. Capability to challenge the status quo to simplify work and improve results. Strategic and proactive mindset. Working Conditions. The incumbent may be expose to the chemical, biological, and pharmaceutical substances, and the mechanical and electronic equipment used to process, test and document manufacturing operations. Regular BMS sites meeting/training are expected within all BMS PR facilities or outside BMS facilities. Outside seminars are expected; frequency depends on project needs. Some travels required to perform evaluations, participate in multi-site initiatives or administrative meetings. Travel will depend on actual management needs but will be of approximately 15% of the incumbent's time.