Senior Manager
- HCLTech
- 11 - 20 years
- Noida, Gurugram
- 5 months ago
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Job Description
Role & responsibilities :
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
Job Classification
Industry: IT Services & ConsultingFunctional Area / Department: Risk Management & ComplianceRole Category: Risk Management & Compliance - OtherRole: Risk Management & Compliance - OtherEmployement Type: Full timeContact Details:
Company: HCLTechLocation(s): Noida, Gurugram
Keyskills: EDMS SDLC ISO9001 Software Development Life Cycle CAPA ISO27001 ISO13845 QMS Documentation 21 Cfr Gxp
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