Investigation Supervisor

Adare Pharma Solutions; Vandalia (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

Adare Pharma Solutions is seeking an Investigations Supervisor in Vandalia, OH to oversee manufacturing investigations related to deviations, non-conformances, batch discrepancies, equipment failures and GMP events. This role provides day-to-day leadership to the investigations team and ensures scientifically sound, compliant investigations.

You will collaborate with Manufacturing, Quality, Engineering, Validation, QC, MS&T and Supply Chain to drive root-cause determinations, CAPA

Qualifications

• Bachelor’s degree with at least 1 year of leadership experience and 4+ years in the pharmaceutical industry.
• Experience leading investigations and implementing CAPAs.
• Experience with deviation management, non-conformance investigations, change control, and quality systems activities.

Responsibilities

• Supervise and coordinate investigations related to 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 and within established timelines.
• Partner with cross-functional departments (Manufacturing, Quality, Engineering, Validation, QC, MS&T, Supply Chain) to gather data and assess impact.
• Review investigation reports for accuracy, completeness, and regulatory compliance.
• Facilitate root cause analyses using 5 Whys, Ishikawa diagrams, process mapping, human factors analysis, and equipment troubleshooting.
• Lead investigations through closure with containment actions, root cause determination, and CAPA implementation.
• Collaborate with process owners to develop and implement CAPAs addressing root causes and recurrence.
• Support and maintain Manufacturing Quality Systems including CAPA, Change Control, deviation management, and NCR programs.
• Develop and maintain departmental metrics and dashboards to measure investigation performance and effectiveness.
• Support continuous improvement by identifying weaknesses and recommending procedural or equipment enhancements.
• Review, revise, and approve SOPs and quality documentation related to manufacturing investigations.
• Maintain visibility on the manufacturing floor to observe operations and support real-time investigations.
• Assist with internal and customer audits and regulatory inspections by presenting investigation documentation and CAPA data.

Skills

Leadership experience

Investigations

CAPA implementation

Cross-functional collaboration

Education

Bachelor’s degree in life sciences

Job description

Adare Pharma Solutions is a global Contract Development and Manufacturing Organization (CDMO) with locations across North America and Italy. We offer a wide range of manufacturing, packaging, and research and development services. Our clients range from growing biotech firms advancing groundbreaking clinical trials to established pharmaceutical companies producing high volumes of approved, widely used medicines.

By combining top talent from the life sciences industry with modern research and manufacturing technologies, Adare enables clients to deliver potentially lifesaving medicines in more easily consumable formats - particularly for patients such as infants or the elderly. This is the meaning behind “Transforming Drug Delivery – Transforming Lives.”

Our Culture

When it comes to being an employee of Adare, although we are located across multiple countries and come from diverse backgrounds, we work together toward a common purpose. Supported by leadership that is experienced and highly regarded in the industry, we are paving the way for a brighter and better future by attracting top talent from both within and beyond the CDMO space.

In addition to delivering high-quality results for our external clients, we foster a collaborative, client-centric culture internally - one where employees support one another, share knowledge, and encourage each other to bring their best selves to work each day.

Why Come to Adare?

Adare is Private Equity owned and poised for growth. Employees are provided with internal development opportunities to progress within the organization, enhancing their professional skills and industry knowledge through Adare’s investment in their growth.

We offer a variety of fields to embark in, including manufacturing, engineering, quality, chemistry, formulations, analytical research and development, finance, supply chain, sales, marketing, project management, human resources, and environmental health and safety. Our benefits package is highly competitive, offering medical, dental, and vision coverage; a retirement plan with company match, paid time off and company holidays, tuition reimbursement with no waiting period, life insurance, pet insurance, Flexible Spending Accounts (medical and dependent care), and disability coverage.

Position

Investigations Supervisor

Location

Vandalia, OH

Summary

The Investigations Supervisor 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.

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 (Ishikawa) 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.

Experience, Education, and Skills Required

• Bachelor’s degree with at least 1 year of leadership experience and 4+ years of experience in the pharmaceutical industry
• Demonstrated experience leading investigations, conducting root cause analyses, and implementing CAPAs.
• Experience with deviation management, non-conformance investigations, change control, and quality systems activities.
• Experience in oral solid dose (OSD) manufacturing environment preferred.

Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.