Quality Manager

Position Summary

SoluFilm is establishing a new GMP manufacturing facility for oral thin-film (OTF) OTC drug products. We are seeking a full-time Quality Assurance (QA) Manager to build and lead the site's Quality System, oversee cleanroom qualification, and ensure full compliance with FDA 21 CFR 210/211 and OTC regulatory requirements.

This role is hands-on and critical to the startup and long-term operation of the manufacturing site. The QA Manager will partner closely with Engineering and Manufacturing leadership.

Key Responsibilities

Quality System Establishment

Develop, implement, and maintain the site Quality System in accordance with FDA cGMP (21 CFR 210/211).

Create and manage core SOPs: document control, change control, training, deviation/CAPA, vendor qualification, cleaning, gowning, environmental monitoring, etc.

Establish and maintain document control and record retention systems.

Cleanroom & Facility Qualification

Lead and approve all cleanroom qualification activities, including IQ/OQ/PQ.

Work with cleanroom builders, HVAC contractors, and third-party certifiers to ensure the facility meets ISO 8 requirements.

Review and approve cleanroom certification reports (ISO 14644, HEPA testing, pressure mapping).

Vendor & Material Qualification

Qualify cleanroom contractor, HVAC/certification vendors, equipment vendors, and ingredient suppliers.

Maintain approved supplier lists and vendor audit documentation.

GMP Compliance Oversight

Ensure compliance with FDA regulations for OTC drug manufacturing.

Establish and manage training programs for all personnel.

Lead deviation investigations, root cause analysis, and CAPA implementation.

Perform internal audits and ensure inspection readiness at all times.

Manufacturing Quality Oversight

Review and approve Master Batch Records (MBRs) and Batch Production Records (BPRs).

Oversee and approve cleaning procedures, equipment qualification, and facility readiness.

Release batches, equipment, and cleanrooms for use.

Interaction with Regulators & Leadership

Prepare for and support FDA inspections and other regulatory audits.

Provide regular quality status updates to senior leadership.

Serve as the primary site contact for all quality-related matters.

Qualifications

Required

Bachelor's degree in a scientific or engineering discipline (Chemistry, Biology, Engineering, etc.).

3–7 years experience in pharmaceutical, OTC drug, dietary supplement, or medical device QA.

Strong working knowledge of FDA 21 CFR 210/211 and GMP expectations.

Experience with cleanroom operations, environmental monitoring, and/or facility qualification.

Hands-on experience writing and approving SOPs.

Experience with deviations, CAPA, change control, and training systems.

Strong communication, documentation, and organizational skills.

Preferred

Experience with new facility build-out, cleanroom commissioning, or IQ/OQ/PQ.

Experience with OTC monograph or oral solid dosage forms.

Familiarity with ISO 14644 cleanroom standards.

Experience in startup or small-team environments.

Working Environment

On-site role at the Indianapolis manufacturing location.

Requires collaboration with engineering, manufacturing, and external contractors.

Must be comfortable working in a small, fast-moving team establishing a new GMP facility.

Why Join SoluFilm

Opportunity to build the Quality Unit from the ground up.

Lead the launch of a new GMP manufacturing site.

High-impact role with strong growth potential as the company scales

Job Type: Full-time

Pay: $80, $120,000.00 per year

Benefits:

• Flexible schedule
• Health insurance
• Paid time off
• Relocation assistance

Experience:

• Quality assurance: 5 years (Required)
• Microsoft Excel: 5 years (Required)

Work Location: In person