Quality Assurance Deviation Lead – Batch & QMS

INCOG BioPharma Services; Fishers (IN); On-site; USD 110,000 - 145,000; Full time

Job summary

INCOG BioPharma Services in Fishers, IN seeks a Quality Assurance Manager to own batch-impacting deviations and QMS records, guiding cross-functional teams through complex investigations without direct reports.

You will manage the deviation lifecycle from initiation to closure, drive on-time disposition, and lead Veeva QMS improvements while reporting metrics to site leadership and clients.

A Bachelor’s degree in Science and 3+ years of pharma QA experience are required.

Qualifications

• Bachelor's degree in Science required; fields may include Chemistry, Biology, Biochemistry, or Engineering.
• Minimum 3 years of QA experience in pharmaceutical/biopharmaceutical manufacturing focused on deviations.
• Direct Veeva Vault QMS experience preferred, including workflows and dashboards.
• Strong working knowledge of cGMP and regulatory expectations.
• Proven ability to influence cross-functional teams without direct authority.

Responsibilities

• Own oversight of batch-impacting deviations in Veeva QMS from initiation through closure.
• Drive cross-functional deviation teams to on-time completion across multiple functions.
• Manage full deviation lifecycle cadence: initiation, triage, investigation, and closure.
• Track batch-gating records tied to open lots and maintain a prioritized work queue.
• Chair deviation and batch-gating review meetings to align priorities.
• Escalate promptly when timelines or data are at risk with recommended paths.

Skills

Deviation management

Root cause analysis

Technical writing

Cross-functional collaboration

GMP/compliance knowledge

Project management

Education

Bachelor's degree in Science (Chemistry, Biology, Biochemistry, Engineering, etc.)

Tools

Veeva Vault QMS

Job description

INCOG BioPharma Services in Fishers, IN seeks a Quality Assurance Manager to own batch-impacting deviations and QMS records, guiding cross-functional teams through complex investigations without direct reports.

You will manage the deviation lifecycle from initiation to closure, drive on-time disposition, and lead Veeva QMS improvements while reporting metrics to site leadership and clients.

A Bachelor’s degree in Science and 3+ years of pharma QA experience are required.