10.0 - 14.0 years

0 Lacs

karnataka

On-site

As the Manager overseeing audit and inspection programs, your primary responsibility is to ensure the proper execution of these programs to maintain compliance with the master audit plan. You will be in charge of designated global audit programs and oversee all aspects such as procedures, execution, quality control, compliance to processes, etc. Your role will involve identifying the scope of audits and leading a global audit team, prioritizing projects for risk-based audits, and ensuring the consistent implementation, use, and review of Standard Operating Procedures (SOPs). It will also be crucial for you to escalate any issues to management promptly and implement appropriate solutions, including preventive actions. You will be expected to negotiate with internal stakeholders to enhance quality and efficiency, analyze and interpret data to drive process improvement initiatives, manage interactions with clients or regulatory agencies effectively, interpret quality regulations/standards, and create relevant policies and procedures. Additionally, you will have responsibilities related to Regulatory Compliance and Quality Assurance (RC and QA) management, ensuring that applicable controlled documents are followed. Your role may also involve other duties as needed or assigned. Minimum qualifications for this role include a bachelor's degree in Life Sciences or equivalent experience. You should have at least 10 years of experience in a regulatory environment, with expertise in GXP roles, GCP, and GVP audits, as well as industry quality systems/standards. You must be able to interpret regulations/standards, lead process improvement initiatives, and effectively communicate and negotiate with internal stakeholders. Preferred qualifications may include relevant experience in place of educational requirements. The job may require some overtime and travel, and it will be office-based with hybrid arrangements as requested by the line manager. Please refer to our EEO & Accommodations policies for further information.,

Posted 2 days ago

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