Serialization Validation Manager

TITLE:
Senior Serialization Validation Manager / CQV Lead

LOCATION:
Flowery Branch, GA (Preferred)
Hybrid with periodic onsite support required

PROJECT DURATION:
6–12 Months

INDUSTRY:
Pharmaceutical Manufacturing / Medical Device Packaging / GMP-Regulated Environment

OVERVIEW

Medmix is implementing its first DSCSA-compliant serialization solution and seeks a senior Validation Manager or CQV Lead to independently own the qualification and validation effort for a new serialization packaging line. This individual will serve as the validation subject matter expert responsible for ensuring the project is executed in compliance with FDA expectations, DSCSA requirements, GMP standards, and internal quality requirements.

The consultant will partner directly with the Healthcare Program Manager and cross-functional Quality, Engineering, Manufacturing, and IT teams while taking ownership of validation strategy, protocol execution, documentation review, gap remediation, and audit readiness.

This is a hands-on execution role requiring a professional capable of operating with minimal oversight and delivering a complete, inspection-ready validation package.

PRIMARY RESPONSIBILITIES

Validation Leadership

• Serve as validation lead and primary owner for serialization qualification activities.
  • Develop and execute overall validation strategy for packaging line serialization implementation.
  • Review project scope and perform validation impact assessments.
  • Conduct validation gap assessments and risk evaluations.
  • Ensure alignment with FDA, GMP, GAMP 5, 21 CFR Part 11, and DSCSA requirements.
  • Provide validation guidance to Engineering, Quality, Operations, and external vendors.

Qualification & Validation Execution

• Review, revise, and execute IQ, OQ, and PQ protocols.
  • Support SAT planning and execution activities.
  • Review and integrate vendor qualification documentation.
  • Lead protocol execution and deviation management.
  • Develop final validation summary reports.
  • Drive issue resolution and CAPA support where required.
  • Ensure complete traceability from requirements through testing and approval.

Serialization & Packaging Systems

• Lead qualification activities associated with Wipotec serialization equipment.
  • Support validation of line-level serialization and aggregation processes.
  • Verify proper operation of print, vision inspection, reject, aggregation, and labeling functions.
  • Validate serialization data flow between packaging equipment and Level 3 serialization systems.
  • Support review of Vimicim serialization platform validation deliverables.
  • Review connectivity to customer serialization repositories and MAH reporting requirements.

Documentation & Compliance

• Review and enhance existing validation templates and protocols.
  • Ensure validation packages are inspection-ready.
  • Maintain audit-ready documentation throughout the project lifecycle.
  • Coordinate review and approval workflows with Quality and Engineering.
  • Minimize document revisions through thorough technical review and planning.
  • Ensure all deliverables support future regulatory inspections and customer audits.

REQUIRED EXPERIENCE

• 10+ years of pharmaceutical, biotech, medical device, or regulated manufacturing validation experience.
  • 5+ years leading qualification and validation programs.
  • Demonstrated ownership of IQ/OQ/PQ execution.
  • Experience supporting FDA-regulated manufacturing environments.
  • Experience authoring validation protocols and summary reports.
  • Strong understanding of GMP validation lifecycle methodologies.
  • Experience working directly with Quality Assurance organizations.
  • Proven ability to independently drive validation activities with minimal supervision.

PREFERRED EXPERIENCE

• DSCSA serialization implementation experience.
  • Serialization equipment qualification experience.
  • Wipotec equipment validation experience.
  • Serialization platform experience including Vimicim, TraceLink, Rfxcel, SEA Vision, Systech, Antares Vision, or Optel.
  • Packaging line qualification experience.
  • Pharmaceutical packaging operations experience.
  • Validation Manager, CQV Lead, or Commissioning & Qualification leadership background.
  • Experience supporting FDA inspections, customer audits, or regulatory readiness programs.

TECHNICAL KNOWLEDGE

• GMP
  • GAMP 5
  • FDA 21 CFR Part 11
  • DSCSA
  • Risk-Based Validation
  • Computer System Validation (CSV)
  • Equipment Qualification
  • Serialization
  • Aggregation
  • IQ/OQ/PQ
  • SAT/FAT
  • Traceability Matrix Development
  • CAPA Management
  • Change Control
  • Validation Lifecycle Management

SUCCESS PROFILE

The ideal consultant is a former Validation Manager or CQV Lead who can immediately assume ownership of the serialization validation effort, independently execute qualification activities, proactively identify compliance gaps, and deliver a complete audit-ready validation package for Medmix's first serialization implementation.