About Us
Headquartered in Princeton, New Jersey, USA, with offices in United Kingdom, Australia, Canada, India, and Germany, we are a leading privately-owned global SaaS company that helps enterprise life sciences organizations accelerate new drug development into approved medicines that save lives and keep employees safe. Through our intelligently designed low-code software platforms, we digitize drug research and development, laboratory testing, regulatory approvals, and pharmaceutical manufacturing on a single, unified cloud platform that is cost-effective, ready to deploy, and easy to use.
Highly regulated companies choose Xybion to help them become more efficient, reduce costs and manage compliance, regulatory adherence and risk. Since our founding in 1977, we have supported through software, services, and consulting, 100% of the top 20 global life sciences companies.
Serving more than 300 customers in 25 countries, we have the global scale and expertise to bring our employees around the world together to drive innovation, manage complex business processes, improve program administration and client service delivery.
Role: Manager Software Quality Assurance
Location: Chennai/Pune
The Senior QA Auditor/Specialist assists the QA Director in the maintenance of Xybion’s Quality Management System, including SOPs and work instructions governing all Xybion companies; completion of internal quality audits and external vendor quality audits, and ongoing monitoring and reviews of applicable product and activity records.The Senior QA Auditor/Specialist assists the QA Director in the maintenance of Xybion’s Quality Management System, including SOPs and work instructions governing all Xybion companies; completion of internal quality audits and external vendor quality audits, and ongoing monitoring and reviews of applicable product and activity records.
Responsibilities:
- Responsible to Xybion’s QA Director for completion of required QA activities associated with Xybion’s office in Chennai, India and
- To have primary responsibility as assigned by Xybion’s QA Director for completion of scheduled internal audits
- To have primary responsibility as assigned by Xybion’s QA Director for vendor audits of Xybion vendors in India, and possibly further afield
- To track follow-up activities and action items resulting from internal audits findings
- Coordinate the creation of Corrective and Preventive Action plans and required follow-up activities
- Assist Xybion’s QA Director with primary QA reviews of product SDLC documentation, including development and QC records, and in-process monitoring to determine level of ongoing compliance to defined process requirements
- Provide QA oversight and guidance to Xybion employees.
Technical Knowledge:
- Able to demonstrate above average understanding of the principles governing good quality auditing and application of quality concepts across different models of software system development lifecycles
- Proficient in SDLC terminology and application of GAMP and ICH quality management principles as they relate to software validation
- Proficient in MS Office
- Able to work independently and in a team-leadership role
- Must be able to independently juggle several priorities
Proficient in written and spoken English – must be able to correct and edit documents authored by others
Experience:
- Minimum 10 Years’ experience in quality assurance in a GxP (FDA or EPA) regulated environment including direct participation in quality systems audits and record reviews – ideally should include experience as a Lead Auditor
- Direct experience validating software for use in an FDA or EPA regulated environment desirable
Education:
Minimum of Bachelor’s degree in a life science or technology field (work experience will be considered in lieu of required degree)
Compensation:
We offer highly competitive compensation, including base salary, sales commission, performance-linked bonus, along with a comprehensive benefits package.
We thank all applicants for their interest; however, only those selected for an interview will be contacted. For more information about Xybion, please visit https://www.xybion.com/.
Xybion is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
What We Do
Digitize - Transform - Innovate
Xybion is a Digital Acceleration cloud platform company with end-to-end all-inclusive Solutions for business processes for highly regulated industries with embedded Quality and Predictive Compliance with Real-Time Monitoring unified on a Single Platform to Help You Manage Your Entire Business Process Seamlessly. Personalize Our Preconfigured Apps or Let us Rapidly Configure New Apps On Our Low-Code XDP Platform To Your Specifications. Your Process- Your Way.
Our out-of-the-box solutions include:
• R&D Execution System: Gold Standard for End-to-End Discovery, Preclinical Research, Development, SEND & Submission.
• Digital Lab Execution System: Quality & Compliance Embedded Cloud-based LIMS, ELN, Scientific Data & Total Laboratory Process Management
• Total Predictive, Quality, Compliance & Risk Management: Total Predictive Compliance, Quality, Risk & Real-time Data Integrity Compliance Monitoring
• Workplace Health and Safety, Medical Care, Case, Compliance & Claims Management: One cloud connecting all stakeholders in a single database.
• Enterprise Content Management: Document Creation, Review, Imaging, Annotation Unified with Core Business Processes and with Quality and Compliance Systems
Xybion has over 160 clients in 29 countries including all of the top 20 biopharmaceutical companies.
