QA Manager: Batch & Deviation Execution

INCOG BioPharma; Fishers, Northern (IN, KY); Hybrid; USD 95,000 - 130,000; Full time

Job summary

INCOG BioPharma in Fishers, IN is seeking a QA Manager for Batch & Deviation Execution to own the deviation lifecycle and ensure on-time batch disposition, partnering across Formulation/Filling, Inspection/Packaging, MS&T, QA, QC, Engineering, Validation, and Supply Chain.

The role requires leading cross-functional teams without direct reporting authority, driving process improvements within Veeva QMS, and delivering inspection-ready documentation.

Qualifications

• Bachelor's Degree required; degree preferred in science/engineering fields.
• Minimum of 3 years of Quality Assurance experience in pharmaceutical/biopharmaceutical manufacturing with deviation management.
• Experience owning or driving deviation/quality event closure to committed timelines in a cGMP environment.
• Hands-on proficiency with an electronic QMS; Veeva Vault QMS experience strongly preferred.
• Strong knowledge of cGMP requirements and regulatory expectations for deviation investigation and CAPA.
• Proficiency with structured investigation methodologies (5 Whys, Ishikawa, etc.).
• Excellent technical writing and document review skills for inspection-ready narratives.
• Ability to influence and drive accountability across functions without direct reporting authority.
• Strong project management and prioritization skills to manage high volume records.

Responsibilities

• Own oversight of batch-impacting deviations in Veeva QMS from initiation through closure with real-time visibility.
• Drive cross-functional deviation teams to on-time completion across multiple functions without direct reporting authority.
• Manage the full deviation lifecycle cadence from initiation to closure with CAPA integration.
• Track batch-gating records tied to open lots and maintain a prioritized disposition-driven queue.
• Chair recurring deviation and batch-gating review meetings to align priorities and decisions.
• Escalate promptly when timelines or data quality risk batch disposition commitments.
• Review deviation content for technical and compliance quality, including root cause and impact.
• Coach writers on investigation methodology and GMP-compliant writing for inspection readiness.
• Support batch disposition decisions by ensuring all events are closed or properly documented.
• Own deviation metrics and KPIs and present performance data to leadership and clients.
• Act as change agent for deviation process improvements and Veeva QMS enhancements.
• Author and update procedures, work instructions, and training content for deviation management.

Education

Bachelor's Degree in Science (Chemistry, Biology, Biochemistry, Microbiology, Engineering)

Job description

INCOG BioPharma in Fishers, IN is seeking a QA Manager for Batch & Deviation Execution to own the deviation lifecycle and ensure on-time batch disposition, partnering across Formulation/Filling, Inspection/Packaging, MS&T, QA, QC, Engineering, Validation, and Supply Chain.

The role requires leading cross-functional teams without direct reporting authority, driving process improvements within Veeva QMS, and delivering inspection-ready documentation.