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Emmes Group
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Senior Manager Quality Assurance

Senior Manager Quality Assurance

Emmes Group

47 years

0 Lacs

bengaluru karnataka india

Posted:1 day ago| Platform:

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Skills Required

research discovery ophthalmology collaborative management leadership regulations support ai software audits verification documentation auditing audit data reports training gcp security nist certification connect twitter

Work Mode

Remote

Job Type

Full Time

Job Description

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Bengaluru, India
Quality Assurance
No
Regular Full-Time
2694

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Overview

Job Description

Job Posting Title

India Remote/Ahmedabad/Bengaluru/New Delhi

Emmes Group: Building a better future for us all.Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.We believe the work we do will have a direct impact on patients’ lives and act accordingly. We strive to build a collaborative 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 embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

The Senior Manager, Computer Systems Quality job oversees aspects of the Quality Management System (QMS) at Emmes and manages staff within 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 quality support for computer system validation activities for Emmes’ proprietary, Veridix AI, and commercial off-the-shelf (COTS) software systems used in clinical trials.
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 related to computerized systems
Manages one of multiple components of Emmes’ Quality 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 quality data for improvements in the QMS
Leads process improvement activities
Leads client 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 related 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 related industry standards required with familiarity with security regulations such as NIST SP 800-53 and FISMA preferred.
CQA, CCRP, ISO certification (or equivalent) preferred

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Senior Manager Quality Assurance