Senior Manager – Quality eCompliance
Location: Mumbai (Kurla), Maharashtra, India
Business Unit: Piramal Critical Care (PCC)
Department: Quality eCompliance
Reporting To: Associate General Manager
Travel Requirement: Low
Job Overview
Piramal Critical Care (PCC) is seeking an experienced Senior Manager – Quality eCompliance to ensure regulatory compliance of IT and electronic systems across global PCC sites and corporate functions. This leadership role supports the implementation of IT automation initiatives for quality processes and ensures adherence to global regulatory standards including 21 CFR Part 11, Annex 11, CSV, CSA, and Data Integrity requirements.
The position requires strong cross-functional collaboration with global stakeholders across India, the UK, the US, and APAC regions to drive governance, compliance, audit readiness, and digital transformation initiatives in regulated pharmaceutical environments.
Key Responsibilities
Support IT and Quality eCompliance initiatives across central and site locations.
Lead and support Computer System Validation (CSV) and IT compliance activities aligned with global regulatory requirements.
Establish governance frameworks across PCC sites (India, UK, US) and conduct periodic compliance review meetings.
Perform central audits and Data Integrity (DI) audits; support regulatory inspections and ensure closure of observations.
Define validation strategies and review CSV deliverables for IT and automation projects.
Ensure lifecycle compliance of computerized systems and CSV documentation.
Monitor third-party vendors and shared service partners engaged in IT compliance activities.
Review and approve QMS documents including change controls, deviations, incidents, and discrepancies.
Perform root cause analysis and define effective CAPA based on compliance findings.
Conduct periodic system reviews and audit trail reviews as per defined frequency.
Perform IT supplier assessments and ensure timely remediation of audit findings.
Liaise with site QeC SPOCs for alignment on CSV and IT compliance initiatives.
Guide and train corporate and site teams on CSV, Data Integrity, and regulatory compliance standards.
Collaborate with CSV and Project Managers to ensure project timelines and compliance milestones are achieved.
Author, review, and approve SOPs, guidelines, and compliance policies.
Escalate data integrity breaches to designated DI champions and management as required.
Minimum Qualifications & Experience
Graduate or Post-Graduate degree in Science, Pharmacy, or related Life Sciences discipline.
10–14 years of experience in pharmaceutical or life sciences domain with strong exposure to IT compliance and CSV.
Hands-on experience with 21 CFR Part 11, EU Annex 11, Data Integrity, GAMP 5, CSV, and CSA methodologies.
Experience working in global pharmaceutical environments with stakeholders across US, Europe, and APAC.
Proven experience managing audits, regulatory inspections, and cross-functional compliance initiatives.
Prior experience in Pharma or regulated IT environments preferred.
Core Competencies
Strong knowledge of IT compliance frameworks and regulatory guidelines.
Expertise in Computer System Validation (CSV), Computer Software Assurance (CSA), and GAMP 5.
Deep understanding of pharmaceutical Data Integrity requirements.
Functional knowledge of manufacturing, quality control, SAP systems, and IT infrastructure qualification.
Knowledge of ITIL processes including backup/restoration, infrastructure qualification, and user access management.
Experience in automation and digitization validation projects preferred.
Awareness of Pharma 4.0 and industry best practices.
Strong leadership, stakeholder management, and communication skills.
About Piramal Critical Care (PCC)
Piramal Critical Care (PCC), a business unit of Piramal Pharma Limited, is a global leader in hospital generics and inhaled anaesthetics. PCC is among the world’s largest producers of inhalation anaesthetics including Sevoflurane, Isoflurane, and Halothane, and also offers Intrathecal Baclofen therapy for spasticity management.
With a presence in over 100 countries and state-of-the-art manufacturing facilities in the US and India approved by US FDA, UK MHRA, and other global regulators, PCC delivers high-quality critical care solutions worldwide. The organization continues to expand its global footprint through innovation, operational excellence, and regulatory compliance leadership.
Equal Employment Opportunity
Piramal Group is an Equal Employment Opportunity and Affirmative Action employer. Employment decisions are based on merit, qualifications, performance, and business needs without discrimination on legally protected grounds. The organization is committed to fair and inclusive workplace practices and provides reasonable accommodations where applicable.
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