Lead IT Systems (R, Q & RIMS) Expert

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

Brief team/department description:

Our Digital team at Azurity is building new capabilities utilizing cutting-edge Lead IT Systems (R, Q & RIMS) Expert. We are looking for a dynamic, change inspired, Dwell b/w multiple system, Individual self-driven hands-on Lead IT Systems (R, Q & RIMS) Expert. Team Member Ability to work onsite during flexible hours to support India, US and EU operations

Job Summary:

We are seeking a dynamic and versatile Lead IT Systems with strong hands-on experience in Research, Quality Management Systems (QMS) and Document Management Systems (DMS), coupled with a working knowledge of RIMS and Lab Systems. This role requires the ability to wear multiple hats, supporting a cross-functional pharma IT landscape that spans Quality, Regulatory, and Laboratory systems. The ideal candidate thrives in a regulated environment, collaborates across functions, and ensures systems remain compliant, validated, and business aligned.

Mandatory Qualifications:

• B.Tech / B.E. in Computer Engineering (Mandatory)
• M.Tech in Computer Engineering / IT (Preferred)

Experience Required:

• 8–10+ years in IT within the pharmaceutical industry
• Deep hands-on experience with TrackWise, Veeva Vault QMS/DMS, AmpleLogic QMS, and exposure to RIMS and Lab Systems
• Expertise in CSV, GxP compliance, 21 CFR Part 11, and audit preparedness
• Strong involvement in data migration activities and end-user training

Soft Skills (Mandatory):

• Strong verbal and written communication
• Effective cross-functional collaboration (Quality, Regulatory, Lab, IT)
• Growth mindset with ability to handle evolving platforms
• Product roadmap alignment and stakeholder influence
• Ability to navigate complexity and ambiguity in stakeholder conversations
• “Multiple Hats" mindset – flexibility to contribute across QMS, DMS, RIMS, and Lab Systems as needed Ability to confidently demonstrate system functionalities and conduct user workshops

Role Distribution:

Responsibilities:

Quality Systems (70%) –Core Hands-On Ownership

• Configure and manage QMS/DMS platforms (TrackWise, Veeva Vault QMS/DMS, AmpleLogic), Other evolving Systems
• Design and optimize CAPA, Change Control, Audit, Deviation, and Document Lifecycle workflows
• Execute and manage CSV lifecycle – URS, IQ/OQ/PQ, RTM
• Provide L2/L3 support, user training, SOP documentation, and handle audit readiness
• Coordinate directly with vendors for system updates, patching, and roadmap discussions
• Lead and execute data migration activities with validation and reconciliation
• Demonstrate QMS/DMS systems confidently to users and auditors

Regulatory Systems (20%) – Supportive Ownership

• Administer Veeva Vault RIM or equivalent RIMS platforms
• Manage registration tracking, submission workflows, and HA interactions
• Collaborate with RA teams to gather requirements, support compliance, and maintain inspection readiness

Lab Systems (10%) – Tactical Support

• Support AmpleLogic LIMS and MPower QC systems
• Monitor instrument integration and data flow (HPLC, GC, FTIR)
• Address sample tracking issues and logbook automation enhancements

Technical Skill Set:

Team Member is expected to wear multiple hats—flexibly contributing to QMS/DMS ownership, RIMS support, and Lab systems troubleshooting as business needs evolve. Agility, accountability, and collaboration are key to success in this hybrid role.

By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.