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.

*Why PWCAt PwC, you will be part of a vibrant community of solvers that leads with trust and creates distinctive outcomes for our 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 for each other. Learn more about us.At PwC, 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 firm's 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 industry's 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:

Bachelor's 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
Not Specified

Available for Work Visa Sponsorship
No

Government Clearance Required
No

Job Posting End Date
April 24, 2026

Senior Quality Assurance Engineer-Software

IN_Senior Associate_QMS Implementation_RC - Internal Audit_Advisory_Noida

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