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Senior Manager- EDMS

4 weeks ago

Noida, Uttar Pradesh, India HCLTech Full time

Position Summary -

Experienced IT Risk & Compliance professional responsible for managing Electronic Document Management Systems (EDMS), ensuring regulatory compliance (FDA, ISO, HIPAA, SOC2), and supporting audits, system validation, and risk mitigation across global teams. Strong expertise in IT controls, privacy, business continuity, and document lifecycle management within GxP environments.

Primary Skill : EDMS Management or auditing

Secondary Skill : Understanding of general IT Control framework, Change control, ISO 9001, IT compliance, and CAPA systems.

Key Responsibilities - Perform the following functions:

  • Required to have an excellent understanding of the IT Control framework, in particular risk assessment and control selection
  • Working experience in any two of the compliance programs (PCI DSS,HIPPA,ISO 27001,SOC2)
  • Partner with DCO/DCM and service delivery leadership to both communicate and manage risk in delivery to an acceptable level
  • Partner with DCO/DCM and delivery team to increase the level of awareness of compliance with policy and process
  • Develops and provides appropriate guidance on solutions to mitigate risks and enhance system security
  • Deep understanding of privacy and business continuity requirements and support R&C Privacy and BCM teams in execution of their respective program
  • Serve as the primary administrator for the validated Electronic Document Management System (EDMS) platform, overseeing day-to-day operations, user support, and system maintenance.

  • • Manage the end-to-end lifecycle of controlled documents including SOPs, Work Instructions, and Quality Policies, ensuring version control, periodic review, and audit readiness.

  • • Lead and support the validation team with the activities related to the EDMS, including developing and executing IQ/OQ/PQ protocols and maintaining validation documentation.

  • • Ensure the EDMS remains compliant with global regulatory requirements (e.g., FDA, EMA, ISO 13485), and support audit and inspection readiness.

  • • Administer user access controls, security roles, and training programs to ensure proper system use and compliance.

  • • Act as the first point of contact for document-related issues, troubleshooting, and escalation to technical teams when necessary.

  • • Collaborate with cross-functional teams (Service Delivery, IT) to drive system improvements and manage change controls related to EDMS functionality.
  • Participate in corporate initiatives, including internal audits, Software Development Life Cycle (SDLC) reviews, major system developments and other strategic initiatives
  • Demonstrates ability to work in virtual team with help of tools and technologies
  • Demonstrates ability to handle conflicting situation & should have strong verbal, written communication & analytical skills
  • Must have systematic and pragmatic approach to problem solving
  • Demonstrates good inter-personal skills, high standards of professional behaviour in dealings with business customers, colleagues and staff
  • Have a good technical awareness and the aptitude to remain up to date with information security and IT developments
  • Ability to communicate Risk to non-IT business owners and support function such as delivery, HR, GWS, Physical Security, Legal, Contracting and others

Education Qualification - Graduate or master's degree in IT, Risk Management, Business Management, or a related field.

Certifications Required - Certification such as ISO13485/ISO90001/ISO27001 are preferred.

Attributes of Ideal Candidate –

  • 10+ years of experience in in Electronic Document Management System or auditing.
  • Knowledge of document control processes in support of GxP operations (GMP, GVP, GCP).
  • Familiarity with change control, IT compliance, and CAPA systems.
  • Strong understanding of system validation principles and regulatory guidelines including GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity standards.
  • Experience supporting audits/inspections and preparing validation or compliance documentation.
  • Excellent organizational, communication, and problem-solving skills.
  • Ability to work independently and collaboratively across global teams.
  • Experience in pharmaceutical, biotechnology, or medical device industry settings is preferred.
  • Strong communication skills
  • Ability to multi-task, prioritize, and meet timelines on deliverables
  • Proficient in MS Office
  • Team Management Skills
  • Able to translate contractual terms into information security controls