IT Compliance and Risk Management Lead
6 days ago
Biocon Biologics, a subsidiary of Biocon Ltd, is an innovation-driven global biopharmaceuticals company. Its mission is to expand access to cutting-edge therapies for patients worldwide by developing high-quality, affordable biosimilars.
As the IT Compliance and Risk Management Lead, you will play a crucial role in ensuring the IT function within our organization is compliant with regulatory requirements. Your expertise in implementing 21 CFR Part 11, EU Annex 11, and GAMP5 guidance will be invaluable in this position.
Key Responsibilities:
- Lead the IT audit and compliance function within the IT Quality and Compliance team.
- Ensure enterprise system audit readiness and compliance.
- Act as the SPOC for information security ISO 27001 for BBL IT.
- Manage multiple priorities (projects, operations, audits, periodic reviews).
- Represent IT during inspections and remediation efforts.
- Proactively identify risks and opportunities for improvement, define solution strategies, and roadmaps.
- Review and approve validation documents.
- Lead project milestone reviews to review all projects and approve milestone transitions.
Qualifications:
- 12+ years of experience in IT, with 8-10 years in the pharmaceutical industry in CSV, quality, and GxP compliance roles.
- Deep expertise in implementing 21 CFR Part 11, EU Annex 11, GAMP5 guidance.
- Experience managing internal/external audits and inspections.
- Strong verbal communication skills for managing global stakeholders.
- Experience in CAPA management, quality metrics, and reporting.
- Deep expertise in SDLC processes, ITIL processes, testing, computer systems validation, and GxP compliance.
- Experience managing senior stakeholder expectations.
- Ability to deal with uncertainties and navigate through ambiguities.
- Experience in pharma manufacturing or quality and clinical is preferred.
Estimated Salary: $120,000 - $180,000 per annum
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