At PwC, our people in operations consulting specialise in providing consulting services on optimising operational efficiency and effectiveness. These individuals analyse client needs, develop operational strategies, and offer guidance and support to help clients streamline processes, improve productivity, and drive business performance. In connected supply chain at PwC, you will focus on optimising supply chain operations and improving end-to-end visibility and collaboration. You will work closely with clients to analyse supply chain processes, identify areas for improvement, and develop strategies to enhance efficiency, reduce costs, and increase responsiveness. Working in this area, you will provide guidance on technology and data analytics to create a connected and agile supply chain network.
Job Overview
PwC US ADVISORY - Manager, CSV/CSA (Pharmaceuticals & Life Sciences Advisory)
The
Manager – CSV/CSA
will lead project delivery and team execution in the Computer System Validation (CSV) and Computer Software Assurance (CSA) space, focusing on Pharmaceuticals & Life Sciences (PLS), including medical devices and biotech clients. This role requires both
hands-on expertise in validation and compliance
as well as
strong leadership skills to manage teams, client stakeholders, and project outcomes
.
Position Requirements
Client & Compliance Leadership
- Lead design and process discussions with clients to ensure compliance with 21 CFR Part 11, Annex 11, and GxP regulatory requirements.
- Act as a trusted advisor to client leadership, guiding decision-making on quality, validation, and compliance transformation initiatives.
- Support client pursuits by showcasing validation expertise, regulatory knowledge, and PwC’s approach to CSA/CSV.
Validation Frameworks & Technical Oversight
- Design and architect validation frameworks for computerized systems, ensuring secure, compliant, and scalable implementations aligned with GAMP 5.
- Oversee end-to-end validation activities for ERP, data warehouses, eQMS, LIMS, MES, and legacy system integrations, ensuring data integrity and regulatory compliance.
- Provide expert technical guidance and troubleshooting through validation, testing, and system implementation.
Deliverables & Quality Assurance
- Develop, review, and approve validation deliverables including Validation Master Plans, Test Strategies, Requirement Specifications, Protocols (IQ/OQ/PQ), Traceability Matrices, Risk Assessments, and Summary Reports.
- Identify process and system gaps; develop risk-based, custom validation specifications to address compliance challenges.
- Ensure best practices, documentation standards, and quality frameworks are consistently followed across engagements.
Team Leadership & Capability Building
- Lead project teams through execution and hyper care phases, actively coaching and mentoring junior consultants.
- Conduct training sessions and knowledge transfer workshops on validation best practices, CSA risk-based approaches, and Part 11 compliance.
- Mentor and guide a team of validation consultants, fostering capability-building in CSV/CSA, regulatory compliance, and digital quality.
Engagement & Delivery Management
- Own project scope, timelines, budgets, and delivery quality, ensuring successful outcomes across multiple client programs.
- Manage client relationships, facilitate workshops, and present findings/recommendations to senior stakeholders.
- Collaborate with cross-functional client teams (Quality, IT, Regulatory) and PwC leadership to ensure seamless delivery.
Business Development & Practice Growth
- Contribute to proposals, solution development, and thought leadership in the CSV/CSA and digital quality space.
- Drive internal knowledge development, playbook creation, and process optimization for future engagements.
Skills Preferred
- Technical / Domain
- Strong expertise in Computer System Validation (CSV) lifecycle and Computer Software Assurance (CSA) methodologies.
- Familiarity with cGMP, GxP, FDA 21 CFR Part 11, Annex 11, and relevant regulatory frameworks.
- Prior experience in validating systems such as eQMS (Veeva, Sparta), LIMS, MES, ERP, CRM or cloud-hosted applications.
- Experience with quality systems (QMS), regulatory inspections, and audit readiness.
- Familiarity with risk-based validation strategies for AI tools, including assessment of intended use, auditability of model outputs, and integration of validation deliverables into GxP workflows
- Consulting / Leadership
- Successfully led at least 2–3 end-to-end CSV/CSA implementation projects, covering planning, execution, and hyper care. (preferably also operated in a managed service environment)
- Demonstrated ability to lead teams of 4–10 resources across multiple engagements.
- Strong problem-solving, executive communication, and stakeholder management skills.
- Proven track record of delivering validation projects on time and within scope.
Educational Background
- MBA (Tier-2 or above) with relevant CSV/CSA background OR B.Tech. / M.Tech. / Life Sciences degree with strong experience in validation and regulatory compliance.
PAST EXPERIENCE:
7–10 years of relevant experience in
Pharmaceuticals, Biotech, or Medical Devices
; prior consulting or client-facing delivery experience preferred.
Additional Information
- Line of Service: Advisory
- Specialism: Operations Transformation – Quality (CSV/CSA)
- Designation: Manager
- Location: Bangalore / Hyderabad (with global client travel as required)
