INSenior AssociateQMS ImplementationRC Internal AuditAdvisoryNoida

Noida - India

Monthly Salary: Not Disclosed

Posted on: 8 days ago

Vacancies: 1 Vacancy

Job Summary

Line of Service

Advisory

Industry/Sector

FS X-Sector

Specialism

Risk

Management Level

Senior Associate

Job Description & Summary

At PwC our people in risk and compliance focus on maintaining regulatory compliance and managing risks for clients providing advice and solutions. They help organisations navigate complex regulatory landscapes and enhance their internal controls to mitigate risks effectively.

Those in governance risk controls and compliance at PwC will be responsible for confirming regulatory compliance and managing risks for clients. Your work will involve providing advice and solutions to help organisations navigate complex regulatory landscapes and enhance their internal controls to mitigate risks effectively.

*WhyPWC

AtPwC you will be part of a vibrant community of solvers that leads with trust and creates distinctive outcomes forour clients and communities. This purpose-led and values-driven work powered by technology in an environment that drives innovation will enable you to make a tangible impact in the real world. We reward your contributions support your wellbeing and offer inclusive benefits flexibility programmes and mentorship that will help you thrive in work and life. Together we grow learn care collaborate and create a future of infinite experiences foreach other. Learn more

about us

AtPwC we believe in providing equal employment opportunities without any discrimination on the grounds of gender ethnic background age disability marital status sexual orientation pregnancy gender identity or expression religion or other beliefs perceived differences and status protected by law. We strive to create an environment where each one of our people can bring their true selves and contribute to their personal growth and the firms growth. To enable this we have zero tolerance for any discrimination and harassment based on the above considerations.

Job Description & Summary: PwC is looking for an experienced Senior Associate to lead and manage Quality Management System (QMS) implementation projects for clients including system selection configuration validation and deployment. This individual will collaborate with client stakeholders to establish or enhance QMS frameworks compliant with regulatory requirements and industrys best practices.

Responsibilities:

Lead client workshops to gather business and quality requirements related to QMS processes and software.
Design and configure QMS solutions tailored to client needs covering modules such as document control CAPA audit management training and change management.
Develop and execute validation protocols (IQ/OQ/PQ) and assist clients in maintaining compliance with regulatory and quality standards (e.g. FDA ISO 9001 ICH Q10).
Create detailed business process maps and system workflows ensuring alignment with quality objectives and compliance.
Manage project deliverables timelines and communicate status updates to both PwC and client leadership.
Support system integration with other enterprise platforms (ERP LIMS etc.) as part of digital quality transformations.
Provide change management and training strategy to ensure smooth system adoption and operational readiness.
Prepare user manuals SOPs validation documentation and deliver training to end-users.
Mentor junior associates and contribute to the development of QMS consulting practice.
3-5 years of experience with QMS system implementation and quality process consulting within regulated industries.
Hands-on experience with QMS software platforms such as Veeva Vault MasterControl Sparta TrackWise ETQ Reliance or similar.
Strong understanding of quality management principles and regulatory standards including ISO 9001 FDA 21 CFR Part 820 ICH Q10 and GxP frameworks.
Proven experience in system validation and documentation practices for compliance.
Experience supporting digital transformations and integration with ERP LIMS and other enterprise systems is beneficial.

Mandatory Skill sets:

Expertise in QMS system configuration workflow design and report generation.
Knowledge of validation lifecycle and quality documentation standards.
Ability to analyze and optimize quality processes leveraging digital tools.
Proficient in Microsoft Office Suite and familiar with project management tools.

Preferred Skill Sets:

Strong project management and leadership skills with ability to influence stakeholders.
Excellent communication skills including client-facing presentations and training delivery.

Years of Experience Required :

3 To 7

Education Qualification:

Bachelors degree in Life Sciences Quality Management Engineering or related fields.

Education (if blank degree and/or field of study not specified)

Degrees/Field of Study required: Bachelor of Engineering

Degrees/Field of Study preferred:

Certifications (if blank certifications not specified)

Required Skills

Quality Management Systems (QMS)

Optional Skills

Accepting Feedback Accepting Feedback Active Listening Analytical Thinking Business Decisions Business Performance Management C-Level Presentations Communication Compliance Frameworks Compliance Policies Compliance Program Implementation Compliance Review Controls Testing Corporate Governance Creativity Embracing Change Emotional Regulation Empathy External Audit Finance Target Operating Model Finance Transformation Financial Reporting Fraud Detection Fraud Prevention Group Facilitation 18 more

Desired Languages (If blank desired languages not specified)

Travel Requirements

Available for Work Visa Sponsorship

Government Clearance Required

Job Posting End Date

April 24 2026

Required Experience:

Senior IC

Line of ServiceAdvisoryIndustry/SectorFS X-SectorSpecialismRiskManagement LevelSenior AssociateJob Description & SummaryAt PwC our people in risk and compliance focus on maintaining regulatory compliance and managing risks for clients providing advice and solutions. They help organisations navigate ...