V&V Functional QA Sr. Consultant

Are you an experienced, passionate pioneer in technology who wants to work in a collaborative environment? As an experienced Verification & Validation Test Lead Senior Consultant you will have the ability to share new ideas and collaborate on projects as a consultant without the extensive demands of travel.

If so, consider an opportunity with Deloitte under our Project Talent Model.

Project Talent Model (PTM) is a talent model that is tailored specifically for long-term, onsite client service delivery.

Recruiting for this role ends on 9/11/2026

Work you'll do/Responsibilities

The Verification & Validation Test Lead Senior Consultant will lead the Verification & Validation (V&V) activities for a Hayward, CA manufacturing site - an 8-application GMP portfolio (all High priority) including TrakSYS v3.1 (MES), EtQ Reliance v2020 (QMS), Genesis v2.0, MESA ViewPoint v1.4.3, MPort v3.2, ITS Data Warehouse, Subversion, and Acronis.

The candidate must bring hands-on V&V lifecycle experience (IQ/OQ/PQ), 21 CFR Part 11 and GAMP 5 compliance knowledge, and the ability to lead site-based stakeholder communication in a cGMP drug-device manufacturing environment.

Act as the onsite V&V testing representative at the Hayward CA site, building trusted relationships with site quality, engineering, and application owners.

Execute V&V lifecycle activities (IQ/OQ/PQ) for validated manufacturing systems - MES (TrakSYS), QMS (EtQ Reliance), process control (Genesis), plant dashboards (MESA ViewPoint), and data integration (MPort).

Author and execute V&V protocols, test scripts, and summary reports aligned to CSV/CSA methodology and risk-based testing framework.

Ensure all V&V documentation meets 21 CFR Part 11, cGMP, and GAMP 5 standards including electronic records, audit trail verification, and data integrity (ALCOA++) compliance.

Lead UAT and qualification coordination - organizing sessions, aligning business testers and quality reviewers, and driving sign-off.

Manage defect and deviation lifecycle with clear stakeholder communication on status, severity triage, and closure timelines.

Support CAPA, change control, and periodic review activities for validated manufacturing systems.

Deliver regular V&V status reports and qualification readiness updates to Hayward site stakeholders and central Testing Shared Services team.

The successful candidate would possess these skills:


* Ability to work independently and collaborate as part of a team


* Effective written and verbal communication skills


* Meticulous attention to detail and quality of work product


* Ability to build and sustain professional relationships


* Ability to lead projects or workstreams


* Ability to manage and prioritize multiple tasks in a fast-paced and dynamic environment


* Strong interpersonal skills and professional demeanor


* Ability to meet deadlines


* Ability to provide clear guidance to others

The Team

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