Biocon
Website:
biocon.com
Job details:
Global Quality & Corporate IT – Technical Manager
Location: Bengaluru, Karnataka
Department: Information Technology – Quality and Corporate IT.
Purpose
Responsible for end-to-end support, technical architecture oversight, vendor, stakeholder management and compliance of GxP-regulated Quality & Corporate IT Systems (QMS, DMS, Artwork. CLMS, GRC Digital platform etc.) within a Life Sciences / Pharmaceutical environment. Ensures availability, validation, data integrity, and audit readiness of Quality applications, with exposure to technical management of assigned IT applications.
Key Responsibilities
IT Application management
- Support Veeva QMS, DMS - document management system, Artwork and other regulated global Quality platforms
- Manage incidents, problems, changes, and releases as per ITIL
- Ensure system uptime, performance, and data integrity
- Coordinate releases, upgrades, and validation impact assessments of the assigned IT systems
Technical management
- Own application architecture, integrations, APIs, and data flows
- Perform architectural impact and validation assessments
- Ensure scalability, security, and compliance
- Ensure all systems adhere to IT security guidelines and standards.
- Support entire Global Quality & Corporate IT team for all technical requirements.
Stakeholder & Vendor Management
- Act as primary IT point of contact for Quality, Compliance and Business stakeholders for all technical-related questions.
- Manage and coordinate vendors, SaaS providers, and system integrators
- Lead service reviews, SLA tracking, and vendor performance management
- Communicate effectively with global stakeholders and leadership
GxP / GMP / Validation/ QMS Governance
- Ensure compliance with GxP, GMP, 21 CFR Part 11, EU Annex 11
- Support CSV (IQ, OQ, PQ)
- Participate in audits and inspections
- Work closely with QA and Compliance teams
- Maintain SOPs, validation documents, and system review artifacts
Skills and Experience
Mandatory
- Experience in support/maintenance of Quality Management Systems in Life Sciences
- ITIL-based application support
- GxP, GMP, CSV, QMS knowledge
- Application architecture exposure with in-depth knowledge of integration to other systems.
Soft Skills and Competencies
- Strong verbal and written communication skills
- Proven stakeholder engagement and relationship management abilities
- Vendor management and negotiation skills
- Ability to work cross-functionally with IT, Quality, Regulatory, and Business teams
- High ownership, accountability, and problem-solving mindset
Preferred
- QMS, Veeva Quality, DMS
- SAP, LIMS, MES integrations
- ITIL certification
- Good understanding of release management
- Expert in GxP understanding
Experience
- 7-12 years overall IT experience
- 4-6+ years in Life Sciences Quality IT
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