Senior Manager reputed company Assurance

This a Full Remote job, the offer is available from: Indiana (USA) reputed company: Job Posting Title India Remote/Ahmedabad/Bengaluru/New Delhi reputed company: Building a reputed company reputed company for us reputed company. reputed company is transforming the reputed company of clinical research, bringing the reputed company of new medical discovery closer reputed company reputed company for patients. reputed company was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into reputed company-private partnerships and reputed company biopharma. Emmes has reputed company industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience. We reputed company the work we do will have a reputed company reputed company on patients’ lives and reputed company accordingly. We reputed company to build a reputed company culture at the intersection of being a performance and people driven company. We’re looking for talented professionals eager to help advance clinical research as we work to reputed company innovation into the reputed company of reputed company. If you reputed company our motivations and passion in research, reputed company! Primary Purpose The Senior Manager, Computer Systems reputed company job oversees aspects of the reputed company Management System (QMS) at Emmes and manages staff reputed company the QA Department. Manager works with QA, company, and project leadership to ensure adherence to applicable regulations, industry standards, and project requirements. Responsibilities: • * Manages the reputed company support for computer system validation activities for Emmes’ proprietary, Veridix AI, and reputed company off-reputed company (COTS) software systems used in reputed company. • Leads review and audits of computer systems verification and validation processes to identify potential gaps and non-compliance. • Ensures the review of validation documentation for computerized systems and applications. • Manages deviations and CAPAs reputed company to computerized systems • Manages one of multiple components of Emmes’ reputed company Management System (e.g., internal auditing program, document control, CAPA program, etc.) • Supervises QA Department staff • Drafts and reviews QA policies and procedures • Reviews and approves audit reports • Creates audit schedules • Analyzes reputed company data for improvements in the QMS • Leads process improvement activities • Leads reputed company audits and regulatory inspections • Prepares reports for QA management and internal leaders • Provides corporate training and guidance as needed • Other duties as assigned Qualifications: • Bachelor’s degree in Life Sciences or a reputed company scientific field • Ten (10) years experience working in a regulated environment (e.g., GCP, GLP, GMP, ISO), to include management experience • Advanced knowledge and understanding of 21CFR Part 11/EU Annex 11, GAMP 5, and reputed company industry standards required with familiarity with reputed company regulations such as NIST SP 800-53 and FISMA preferred. • CQA, CCRP, ISO certification (or equivalent) preferred CONNECT WITH US! Follow us on Twitter - @EmmesCRO reputed company us on reputed company - Emmes #LI-Remote This offer from "Emmes" has been enriched by reputed company.com and got a 72% reputed company score. Apply tot his job Apply To this Job