Manager, QA Floor Operations

Penn Life Sciences is seeking an experienced Manager, QA Floor Operations to join our team in Langhorne, PA.

The Manager, QA Floor Operations is responsible for providing real-time Quality Assurance leadership and oversight of sterile manufacturing and packaging activities. This role serves as the primary QA authority on the manufacturing floor, ensuring aseptic operations are executed in compliance with cGMP requirements, approved procedures, and internal quality standards. The position partners closely with Manufacturing, Quality Control, and Facilities to support compliant batch execution, effective issue resolution, and ongoing inspection readiness within a sterile injectable environment.

This position’s responsibilities will include, but not be limited to the following:

• Provide continuous, on-floor Quality Assurance oversight of sterile manufacturing and packaging operations, including aseptic processing and critical process controls.
• Review and approve line clearances, room and equipment release, and product changeovers to ensure compliance with aseptic and procedural requirements.
• Review executed batch production and packaging records for accuracy, completeness, and compliance prior to batch disposition.
• Exercise real-time QA decision-making authority during manufacturing operations, including assessment and escalation of deviations, interventions, and aseptic risks.
• Oversee and support deviation investigations, root cause analyses, and CAPA related to on-floor manufacturing activities.
• Support sterility assurance initiatives, including environmental monitoring oversight, media fills, and contamination investigations.
• Provide leadership during internal audits and regulatory inspections, including direct on-floor interaction with inspectors as required.

We are looking for applicants with:

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biology, Engineering, or a related scientific discipline required.
• 7–10 years of progressive Quality Assurance experience within a cGMP-regulated sterile injectable manufacturing environment.
• Demonstrated experience providing on-floor QA oversight of aseptic manufacturing operations.
• Prior experience leading or managing QA Operations or QA Floor teams in a sterile manufacturing facility.
• Strong knowledge of aseptic processing, sterility assurance, data integrity (ALCOA+), and cGMP regulations (21 CFR Parts 210/211).

What we offer:

• 401(k) with company match
• Health, vision, and dental Insurance
• Childcare expense reimbursement
• Tuition reimbursement
• Annual bonus eligibility
• Annual merit increases
• Paid Time Off and Flexible Holidays

Penn Life Sciences is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status.

We encourage you to apply if you feel that you are a match! We look forward to hearing from you.