*Associate Director, Digital Systems, Validation & Governance

Pharmanovia; Maharashtra; In loco; INR 6.000.000 - 12.000.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive salary

Career development

Digital transformation

Inclusive culture

Descrizione del lavoro

Pharmanovia is seeking an Associate Director, Digital Systems, Validation & Governance to lead strategy and governance of digital systems across the organisation. You will ensure validation, data integrity and risk management throughout the lifecycle, collaborating with Quality, IT and business units.

The role focuses on enabling digital transformation, robust documentation, and ensuring systems remain compliant and fit for purpose to support reliable business processes.

Competenze

• ITIL V3/V4 Foundation (essential).
• CSV/GxP training (desirable).
• Degree-level education and equivalent experience (desirable).

Mansioni

• Own the CSV lifecycle for all relevant business systems with validation and audit readiness.
• Act as SME during audits, defending system controls and supporting regulatory discussions.
• Lead cross-functional Change & Release procedures and ensure validated processes.
• Map and document end-to-end business processes with SOPs and governance.
• Provide governance for system configurations, access controls and integrations.
• Mentor teams and drive governance maturity across functions.

Conoscenze

ITIL V3/V4 Foundation

CSV/GxP training

Degree-level education

Formazione

Degree-level education

Descrizione del lavoro

We are seeking an Associate Director, Digital Systems, Validation & Governance to lead the strategy, oversight and governance of digital systems across the organisation. The role ensures systems are fit for purpose, secure, compliant and maintained throughout their lifecycle, with particular focus on validation, data integrity and risk management. Working closely with business, technology, quality, compliance and operational teams, the Associate Director will strengthen governance, enable effective digital transformation and support reliable, compliant business processes.

Key Responsibilities

• Computer Systems Validation (CSV) & Compliance

  • Own the CSV lifecycle for all relevant business systems, ensuring validation, documentation, traceability, and audit readiness.
  • Coordinate and collaborate with CSV Quality Specialists to define validation approaches, risk classifications, and documentation standards.
  • Ensure all system changes follow validated processes and meet regulatory expectations.
  • Maintain validation packages, risk assessments, and evidence for internal and external audits.

• Audit Support & Regulatory Engagement

  • Act as a key SME during internal and external audits, providing evidence, defending system controls, and supporting regulatory discussions.
  • Ensure all systems and processes under ownership consistently achieve zero findings.
  • Strengthen audit readiness through robust documentation, governance, and risk management.

• Governance, Change & Release Management

  • Lead the cross functional definition of the CSV approved Change & Release Procedure used across all business systems.
  • Govern how system changes are assessed, validated, documented, approved, and released.
  • Ensure alignment between Quality, IT, system owners, and business stakeholders.
  • Approve or block system go lives based on validation status, risk assessment, and compliance impact.
  • Detect and mitigate change collisions across systems and departments.

• Business Process Architecture & Documentation

  • Lead cross functional process mapping initiatives across Finance, Supply Chain, and other departments.
  • Coordinate workshops, gather requirements, and document end to end business processes.
  • Produce foundational SOPs, KBAs, and procedural documentation to support business operations.
  • Establish governance for documentation ownership and handover to business process owners.
  • Standardise training delivery across departments to ensure consistent adoption of validated processes.

• Systems Ownership & Technical Governance

  • Act as systems technical and governance SME for key platforms including SAP ERP, Veeva RIM’s, TrackWise QMS, SolarWinds Service Management, IT Infrastructure, and other critical business systems,
  • Ensure system configurations, access controls, and workflows meet compliance and operational requirements.
  • Provide SME input on system integrations, upgrades, and new implementations.
  • Maintain oversight of system performance, stability, and risk.

• Cross Functional Leadership & Collaboration

  • Work closely with Quality, Finance, Supply Chain, Commercial, and IT to ensure alignment of systems and processes.
  • Lead the onboarding and integration of newly acquired sites and systems into Pharmanovia’s governance framework.
  • Mentor and delegate to the Digital Transformation Analyst, ensuring quality and consistency of outputs.
  • Drive continuous improvement initiatives to enhance governance maturity and operational efficiency.

Qualifications

• ITIL V3/V4 Foundation (essential)
• CSV/GxP training (desirable)
• Degree‑level education and equivalent experience (desirable)

Required Skills

• 10+ years of relevant experience
• Minimum 3 years’ experience managing employees in a similar environment/role.
• Project management.
• Budget and forecasting management.
• Good understanding of similar business environment.
• Service management or support incident management, escalation and related disciplines.
• Experience working with major business systems
• Ability to handle difficulties, performance problems and conflict between team members.
• Systems Audit Defence Experience
• Systems Change and Release Delivery Experience
• Experience with major business systems (e.g., QMS, ERP, CRM, HR, ITSM monitoring platforms).
• Experience with Computer Systems Validation against Change and Release Practices.
• Experience with Business Process Analysis and Design
• Good communication, both written and verbal, technical and non-technical.
• Be able to demonstrate IT related problem-solving skills
• Strong technology landscape and app support.
• Support and mentor junior staff.
• Focus on project opportunities and transformation initiatives.
• Good reporting skills to board level.
• Good technical knowledge outside of the details.
• Good level of professionalism.
• Leadership and management skills.
• ITIL qualified, minimum Service Operations and CSI.
• Agile Change/Release Management Experience
• Strong experience in Microsoft Collaboration technologies focusing on SharePoint Online.
• Service desk/management systems experience.
• Ability to manage multiple priorities in a dynamic environment.
• Approachable, friendly and confident personality.
• Interpersonal communication.
• Proactive and enthusiastic.
• Honesty, integrity and passion for the business.
• Attention to detail.
• Good organisational skills.

What we offer (benefits & career development)

• Competitive salary and benefits package.
• Opportunity to shape digital systems governance and validation across the organisation.
• Professional development and opportunities to contribute to strategic digital transformation initiatives.
• An inclusive workplace culture that supports collaboration and work-life balance.

We are an equal opportunities employer and welcome applications from candidates of all backgrounds.