V&V Functional QA Sr. Consultant

Work You'll Do/Responsibilities

• 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.
• 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 User Acceptance Testing (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 Corrective Action Preventative Action (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.

Qualifications

• 5+ years of executing 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.
• 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.
• Bachelor's degree, preferably in information technology, business, or healthcare related field; or equivalent experience.
• Limited immigration sponsorship may be available.

Pay

The wage range for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Deloitte, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.

Schedule

A reasonable estimate of the current range is $120,200 - $145,000.