Supervisor. Manufacturing Investigations

Adare Pharma Solutions•Vandalia, OH

6d•Onsite

About The Position

The Supervisor, Manufacturing Investigations is responsible for overseeing and coordinating manufacturing investigations related to deviations, non-conformances, batch discrepancies, equipment failures, environmental excursions, out-of-trend (OOT) events, and other GMP-related incidents. This role provides day-to-day leadership to the investigations team while ensuring investigations are conducted in a scientifically sound, compliant, and timely manner.

Requirements

Bachelor’s degree with 4+ years of experience in the life sciences industry
Demonstrated experience leading investigations, conducting root cause analyses, and implementing CAPAs.
Previous direct management experience
Experience with deviation management, non-conformance investigations, change control, and quality systems activities.

Nice To Haves

Experience in oral solid dose (OSD) manufacturing environment preferred.

Responsibilities

Supervise and coordinate investigations related to manufacturing deviations, non-conformances, batch discrepancies, process failures, equipment malfunctions, material discrepancies, environmental excursions, and GMP-related events.
Provide leadership and guidance to investigators, ensuring investigations are completed accurately, thoroughly, and within established timelines.
Partner with cross-functional departments including Manufacturing, Quality, Engineering, Validation, QC, MS&T, and Supply Chain to gather data, conduct fact-finding activities, and assess product and process impact.
Review investigation reports for accuracy, completeness, technical content, and compliance with internal procedures and regulatory expectations.
Facilitate root cause analyses using structured problem-solving methodologies such as 5 Whys, Fishbone diagrams, process mapping, human factors analysis, and equipment troubleshooting techniques.
Lead investigations through closure, ensuring appropriate containment actions, root cause determination, and CAPA implementation.
Collaborate with process owners to identify, develop, and implement effective CAPAs that address root causes and reduce recurrence.
Support and maintain Manufacturing Quality Systems including CAPA, Change Control, deviation management, and non-conformance investigation programs.
Develop and maintain departmental metrics and dashboards to measure investigation performance, compliance, and operational effectiveness.
Support continuous improvement initiatives by identifying process weaknesses and recommending procedural, training, system, or equipment enhancements.
Review, revise, and approve SOPs, work instructions, and quality documentation related to manufacturing investigations and quality systems.
Maintain a visible presence on the manufacturing floor to observe operations, interview personnel, and support real-time investigations.
Support internal audits, customer audits, and regulatory inspections by presenting investigation documentation, CAPA strategies, and effectiveness data.
Assist with manufacturing readiness and pre-campaign activities to support compliant production operations.