Exprienced AssociateManufacturing ExcellenceQuality

Job Description

AssociatePPDM Quality

Industry: Management Consulting

Job Family: Physical Product Development and Manufacturing (PPDM)

Specialism: Operations

Management Level:Associate/Senior Associate

Travel Requirements: Travel to client locations may berequiredas per project requirements.

Job Summary:

PwCs Operations TransformationPPDMQuality team partners with organizations across Pharmaceuticals and Life Sciences Medical Devices and Health Industries to modernize Quality end to end. We help clients design digital-first Quality operating models re-engineer QMS processes and embed scientific and operational excellence linking patient safety and regulatory compliance (CSV/GxP) to measurable business performance.

In this role you will lead Quality transformations across Digital Quality QMS and process optimization and shop-floor excellence. You will assess maturity define roadmaps implement and scale solutions such aseQMSand MES integrations and analytics enableinspectionreadiness and coach client teams. Outcomes include fewer deviations faster CAPA closure higherRight-First-Time(RFT)and uptime quicker batch release andlowercost of quality for global clients.

Knowledge Preferred:

• Digital Quality & Platforms Experience witheQMS(e.g. Veeva Sparta/TrackWise) platform architecture and configuration integrations with adjacent systems (MES/LIMS/ERP) and building real-time dashboards/analytics; ability to define Digital Quality maturity roadmaps aligned to Quality 4.0.

• QMS Compliance & Validation End-to-end QMS processexpertise(Change Control CAPA Deviations Document/Record Management Data Integrity Inspection Management) Quality Risk Assessment & Management remediation programs QA/QC aseptic and sterile manufacturing fundamentals Computer System Validation (CSV) and quality process validation and strong command ofGxPoperational controls.

• Scientific & Operational Excellence Proven application of Lean/Six Sigma/TPM to drive cycle-time right-first-timeyieldand uptime; establishment of engineering standards and lab/manufacturing excellence; benchmarking and tiered governance to sustain continuous improvement.

• Regulatory Clinical & Patient-Safety Processes Working knowledge of healthcare regulatory expectations and cross-functional processes including patient safety and clinical development with the ability to align quality processes and digital solutions to these lifecycle requirements.

• Operating Model & Culture Change Ability to design operating mechanisms and shape Organizational DNA and culture that enable adoption change management training and measurable business outcomes (e.g. reliability of

Skills Preferred:

• Leading and delivering significant business results by applying strategic thinking structured problem-solving innovation and taking individual initiative
• Managing complex client engagements and project workstreams with minimal supervision
• Building and sustaining trusted relationships with team members/clients and driving client value
• Communicating effectively across varied business contexts and stakeholder levels (verbal and written)
• Performing quantitative and qualitative analyses including benchmarking root cause analysis and operational assessments
• Demonstrated ability to manage cross-functional teams and mentor junior consultants
• Experience with digital quality systems including VeevaTrackWise ETQ etc.; certifications or implementation experience ineQMSand Computer System Validation/Configuration is highly desirable
• Exposure to or experience in business development (e.g. proposal development solution design client pitches) is preferred

Qualifications:

Educational Background:

Bachelorsin pharmacy Life Sciences or Engineering desirable

MBA in Operations (Preferred)

Past Experience:

Prior relevant work experience aligned with the required knowledge and skills.

Associate: 2-4years of experience